Chinese Medicine Bill



Make provisions for the registration of practitioners in Chinese medicine; the licensing of traders in Chinese medicines; the registration of proprietary Chinese medicines; and other related matters.

Enacted by the Legislative Council.

PART I
Preliminary

1. Short title and commencement

(1) This Ordinance may be cited as the Chinese Medicine Ordinance.

(2) This Ordinance shall come into operation on a day to be appointed by the Secretary for Health and Welfare by notice in the Gazette, and different days may be so appointed for different provisions.

2. Interpretation

In this Ordinance, unless the context otherwise requires---

"active ingredient" (有效成分) in relation to a proprietary Chinese medicine, means a substance or compound that is used or is intended to be used in the manufacture of the proprietary Chinese medicine and that contributes to the pharmacological effect or effects of the proprietary Chinese medicine;

"board" (組) means the Practitioners Board or the Medicines Board established under section 12;

"certificate of registration" (註冊證明書)---

(a) in relation to a registered Chinese medicine practitioner registered under section 69, means a certificate issued under section 72;

(b) in relation to a proprietary Chinese medicine, means a certificate issued under section 121;

"Chairman" (管委會主席) means the Chairman of the Council and includes any person elected to act as temporary Chairman at any meeting of the Council in accordance with the standing orders made under section 49;

"Chinese herbal medicine" (中藥材) means any of the substances specified in Schedule 1 or 2;

"Chinese Medicines Committee" (中藥管理小組) means the committee established under section 25(1)(b)(i);

"Chinese Medicines Traders Committee" (中藥業管理小組) means the committee established under section 25(1)(b)(ii);

"committee" (小組) means a committee established under section 25 or 39;

"Council" (管委會) means the Chinese Medicine Council of Hong Kong established under section 3;

"Director" (署長) means the Director of Health or a Deputy Director of Health;

"Disciplinary Committee of Chinese Medicine Practitioners" (紀律小組) means the committee established under section 25(1)(a)(iii);

"dispense" (配發) means the preparation and supply of Chinese herbal medicines on or in accordance with a prescription given by a registered Chinese medicine practitioner, a listed Chinese medicine practitioner or a person who continues to practise Chinese medicine by virtue of section 90(7), and "dispensing" (配發) and

"dispenser" (配劑員) shall be construed accordingly;

"due inquiry" (適當的研訊) means an inquiry by the Practitioners Board conducted substantially in accordance with the prescribed procedure;

"Examination Committee" (考試小組) means the committee established under section 25(1)(a)(ii);

"functions" (職能) includes duties and powers;

"label" (標籤) includes any statement forming part of or affixed to the container or package of Chinese herbal medicines or proprietary Chinese medicines;

"Licensing Examination" (執業資格試) means the Chinese Medicine Practitioners Licensing Examination set and conducted by the Practitioners Board under section 59;

"limited registration" (有限制註冊)means registration under section 85;

"listed Chinese medicine practitioner" (表列中醫) means a Chinese medicine practitioner whose name is entered on the list maintained by the Practitioners Board under section 90;

"manufacture" (製造) in relation to a proprietary Chinese medicine, means the preparation, production, packing or re-packing of the proprietary Chinese medicine for sale or distribution, and "manufacturer" (製造商) shall be construed accordingly;

"manufacturer licence" (製造商牌照) means a licence issued under section 132;

"Medicines Board" (中藥組) means the Chinese Medicines Board established under section 12(b);

"package" (包裝)---

(a) means any box, packet or other article in which any proprietary Chinese medicine is enclosed; and

(b) in the case where such box, packet or other article is enclosed in one or more other boxes, packets or other articles, includes each of the boxes, packets or articles in question;

"package insert" (說明書) means any leaflet, notification or other written material supplied with the package of a proprietary Chinese medicine to provide information in respect of the proprietary Chinese medicine, but does not include a label;

"practising certificate" (執業證明書) means a certificate issued under section 76;

"practising Chinese medicine" (作中醫執業、以中醫方式行醫) means any of the following act or activities---

(a) the diagnosis, treatment, prevention or alleviation of any disease or any symptom of a disease;

(b) the prescription of Chinese herbal medicines or proprietary Chinese medicines;

(c) the regulation of the functional states of the human body,

on the basis of traditional Chinese medicine in general practice, acupuncture or bone-setting, and "Chinese medicine practice" or "practice of Chinese medicine" (中醫執業) shall be construed accordingly;

"Practitioners Board" (中醫組) means the Chinese Medicine Practitioners Board established under section 12(a);

"prescribed" (訂明) means prescribed by regulations made under section 160;

"process" or "processing" (炮製) means any type of treatment or preparation applied to a Chinese herbal medicine or mixture of Chinese herbal medicines based on traditional Chinese medicine before it is being---

(a) offered for sale;

(b) supplied to a patient; or

(c) used for the manufacture of a proprietary Chinese medicine;

"proprietary Chinese medicine" (中成藥) means any proprietary product---

(a) composed of any Chinese herbal medicines or any other materials of herbal, animal or mineral origin customarily used by the Chinese;

(b) formulated in a finished dose form; and

(c) known or claimed to be used for the diagnosis, treatment, prevention or alleviation of any disease or any symptom of a disease in human beings, or for the regulation of the functional states of the human body;

"Register" (註冊名冊) means the Register of Chinese Medicine Practitioners kept in accordance with section 52;

"registered Chinese medicine practitioner" (註冊中醫)---

(a) means a person whose name appears on the Register and who is registered under section 69 or 85;

(b) excludes a person whose name is entered on the list maintained by the Practitioners Board under section 90;

"registered particulars" (註冊詳情) means the particulars of a proprietary Chinese medicine required under section 121(1)(b);

"Registrar" (註冊主任) means the Registrar of Chinese Medicine Practitioners appointed under section 51;

"registration assessment" (註冊審核) means the assessment conducted by the Practitioners Board under section 94;

"Registration Committee" (註冊事務小組) means the committee established under section 25(1)(a)(i);

"Regulatory Committee of Chinese Medicines Traders" (中藥業監管小組) means the committee established under section 25(1)(b)(iii);

"retail" or "retailing" (零售) means the selling of any Chinese herbal medicines to a person who obtains the same other than for the purpose of wholesale, and

"retailer" (零售商) shall be construed accordingly;

"retailer licence" (零售商牌照) means a licence issued under section 114;

"Secretary" (局長) means the Secretary for Health and Welfare;

"sell" (銷售、出售) includes---

(a) offer or expose for sale;

(b) supply without payment; and

(c) offer or expose for supply without payment,

and "sale" (銷售) and "seller" (銷售商) shall be construed accordingly;

"trade of Chinese medicines" (中藥業) means the carrying out of business in the dispensing, retailing, wholesale dealing, manufacturing, importing, or processing of any Chinese herbal medicine or proprietary Chinese medicine, as the case may be, and "Chinese medicines trader" (中藥業者) shall be construed accordingly;

"wholesale" (批發) or "wholesale dealing" (批發交易) means---

(a) the importing and selling; or

(b) the obtaining and selling,

of any Chinese herbal medicine or proprietary Chinese medicine to---

(i) a manufacturer; or

(ii) a person who obtains such medicine for the purpose of---

(A) selling again; or

(B) supplying or causing to supply,

such medicine to a third party in the course of business or activity carried out by that person, and "wholesaler" and "wholesale dealer" (批發商) shall be construed accordingly;

"wholesaler licence in Chinese herbal medicines" (中藥材批發商牌照) means a licence issued under section 115;

"wholesaler licence in proprietary Chinese medicines" (中成藥批發商牌照) means a licence issued under section 135.

PART II
The Chinese Medicine Council of Hong Kong

3. Establishment of Council

There is established a council called the Chinese Medicine Council of Hong Kong.

4. Composition of Council

The Council shall consist of---

(a) the Director who shall be an ex officio member; and

(b) the following 18 members, each of whom shall be appointed by the Chief
Executive---

(i) a Chairman;

(ii) 2 public officers;

(iii) 5 Chinese medicine practitioners;

(iv) 5 persons from the trade of Chinese medicines;

(v) 2 persons from educational institutions in Hong Kong; and

(vi) 3 lay persons.

5. Terms of appointment of members

(1) Subject to subsection (3) and section 7, a member of the Council appointed under section 4(b) shall hold office for such period not exceeding 3 years as may be specified in the letter of his appointment.

(2) A member may, upon the expiry of his term of office, be reappointed.

(3) A member appointed under section 4(b) or reappointed under subsection (2) may, at any time before the expiry of his term of office, resign his office by giving notice in writing---

(a) in the case of a member other than the Chairman, to the Chairman;

(b) in the case of the Chairman, to the Chief Executive.

6. Replacement members

Where, before the expiry of his term of office, a member of the Council appointed under section 4(b) resigns or his office becomes vacant, the Chief Executive may appoint a person who is suitably qualified for appointment under section 4(b) to hold office in place of that member until the expiry of the period for which he was appointed.

7. Vacation of office

Where---

(a) a member of the Council---

(i) is sentenced to imprisonment, whether suspended or not, for any offence by any court or magistrate in Hong Kong or elsewhere;

(ii) is the subject of an order made under section 98; or

(iii) becomes bankrupt or enters into a composition or scheme of arrangement with his creditors within the meaning of the Bankruptcy Ordinance (Cap. 6); or

(b) the Chief Executive---

(i) is satisfied that a member of the Council is no longer ordinarily resident in Hong Kong; or

(ii) is of the opinion that a member of the Council is unable or unfit to perform his duties and exercise his powers as a member of the Council, the Chief Executive may declare his office as a member of the Council to be vacant, and shall notify the fact in such manner as the Chief Executive thinks fit; and upon such declaration the office shall become vacant.

8. Temporary members

(1) If a member of the Council appointed under section 4(b) is, because of illness or any other reasons, unable to perform his duties and exercise his powers as a member of the Council for any period, the Chief Executive may appoint another person who is suitably qualified for appointment under section 4(b), not being one whose office has been declared vacant under section 7 or who is disqualified from holding office under section 9, to be a temporary member of the Council in place of the member during that period.

(2) While any person is acting as a temporary member of the Council, he shall be capable of performing all the duties and of executing all the powers of the member whom he is temporarily replacing.

9. Disqualification

Notwithstanding anything in the foregoing provisions, a person---

(a) against whom an order under section 98 has at any time been made;

(b) who is---

(i) undergoing a sentence of imprisonment;

(ii) an undischarged bankrupt;

(iii) not ordinarily resident in Hong Kong; or

(c) whom the Chief Executive considers unfit for appointment,

shall not be eligible for appointment or reappointment, as the case may be, as a member of the Council.

10. Council secretary and legal adviser

(1) The Council shall have---

(a) a Council secretary; and

(b) a legal adviser who shall be a solicitor or counsel.

(2) The persons specified in subsection (1)(a) and (b) shall be appointed by the Secretary.

11. Functions of Council

(1) The functions of the Council shall be---

(a) to ensure adequate standards of professional practice and professional conduct in the profession of Chinese medicine practitioners;

(b) to promote professional education of Chinese medicine practitioners;

(c) to ensure adequate standards of practice and conduct in the trade of Chinese medicines;

(d) to promote and ensure---

(i) the proper use of Chinese herbal medicines;

(ii) the safety, quality and efficacy of proprietary Chinese medicines;

(e) to co-ordinate and supervise the activities of the boards; and

(f) to carry out any other functions assigned to it under this Ordinance.

(2) Without prejudice to the generality of subsection (1)(e), the Council shall co-ordinate and supervise the activities of the boards by---

(a) determining the policies to be implemented by the boards;

(b) examining policy matters in relation to the activities of the boards;

(c) examining any proposals, recommendations and reports from the boards regarding the activities of the boards or the implementation of policies and directing the boards to amend any of such proposals or recommendations as it thinks fit;

(d) handling appeals against decisions of the boards as provided for under this Ordinance;

(e) providing any advice and assistance as may be required by the boards; and

(f) exercising its powers under this Ordinance in such manner as it considers most conducive to the satisfactory performance by each board of the board's functions under this Ordinance.


(3) In this section, "boards" (各組) means the Practitioners Board and the Medicines Board.

PART III
The Chinese Medicine Practitioners Board
and the Chinese Medicines Board

12. Establishment of boards

There are established---

(a) the Chinese Medicine Practitioners Board; and

(b) the Chinese Medicines Board.

13. Composition of Practitioners Board

The Practitioners Board shall consist of the following members, each of whom shall be appointed by the Secretary---

(a) a chairman who shall be a member of the Council;

(b) 2 public officers;

(c) 6 Chinese medicine practitioners, 2 of whom shall be members of the Council;

(d) 1 person from the trade of Chinese medicines;

(e) 1 person from an educational institution in Hong Kong; and

(f) 3 lay persons.

14. Composition of Medicines Board

The Medicines Board shall consist of the following members---

(a) the Director who shall be the chairman; and

(b) the following persons, each of whom shall be appointed by the Secretary---

(i) 2 public officers;

(ii) 5 persons from the trade of Chinese medicines, 2 of whom shall be members of the Council;

(iii) 2 Chinese medicine practitioners;

(iv) 1 person from an educational institution in Hong Kong; and

(v) 3 lay persons.

15. Appointment to boards

(1) Subject to sections 13 and 14, the Secretary may appoint members of the Council, and persons who are not such members, to be members of the Practitioners Board and the Medicines Board.

(2) Unless a contrary intention appears in the context, a reference to a member of a board includes a reference to the chairman of the board. 16. Terms of appointment of members

(1) Subject to subsections (3) and (4) and section 18, a member of the Practitioners Board appointed under section 13 and a member of the Medicines Board appointed under section 14(b), as the case may be, shall hold office for such period not exceeding 3 years as may be specified in the letter of his appointment.

(2) A member of a board may, upon the expiry of his term of office, be reappointed.

(3) A member of the Practitioners Board appointed under section 13 or reappointed under subsection (2) may, at any time before the expiry of his term of office, resign his office by giving notice in writing---

(a) in the case of a member other than the chairman, to the chairman;

(b) in the case of the chairman, to the Secretary.

(4) A member of the Medicines Board appointed under section 14(b) or reappointed under subsection (2) may, at any time before the expiry of his term of office, resign his office by giving notice in writing to the chairman.

17. Replacement members

Where, before the expiry of his term of office, a member of a board resigns or his office becomes vacant, the Secretary may appoint a person who is suitably qualified for appointment to hold office in place of that member until the expiry of the period for which he was appointed.

18. Vacation of office

Where---

(a) a member of a board---

(i) is sentenced to imprisonment, whether suspended or not, for any offence by any court or magistrate in Hong Kong or elsewhere;

(ii) is the subject of an order made under section 98; or

(iii) becomes bankrupt or enters into a composition or scheme of arrangement with his creditors within the meaning of the Bankruptcy Ordinance (Cap. 6); or

(b) the Secretary---

(i) is satisfied that a member of a board is no longer ordinarily resident in Hong Kong; or

(ii) is of the opinion that a member of a board is unable or unfit to perform his duties and exercise his powers as a member of the board, the Secretary may declare his office as a member of the board to be vacant, and shall notify the fact in such manner as the Secretary thinks fit; and upon such declaration the office shall become vacant.

19. Temporary members

(1) If a member of a board is, because of illness or any other reasons, unable to perform his duties and exercise his powers as such member for any period, the Secretary may appoint another person suitably qualified for appointment to such membership to be a temporary member in place of the member during that period.

(2) While any person is acting as a temporary member of a board, he shall be capable of performing all the duties and of executing all the powers of the member whom he is temporarily replacing. 20. Disqualification

Notwithstanding anything in the foregoing provisions, a person---

(a) against whom an order under section 98 has at any time been made;

(b) who is---

(i) undergoing a sentence of imprisonment;

(ii) an undischarged bankrupt;

(iii) not ordinarily resident in Hong Kong; or

(c) whom the Secretary considers unfit for appointment,

shall not be eligible for appointment or reappointment, as the case may be, as a member of a board.

21. Cessation of membership

If during the period of his office, a member of a board who is not a member of the Council when appointed, becomes a member of the Council, he ceases to be a member of the board.

22. Continuation of membership

If during the period when the Practitioners Board or the Medicines Board, as the case may be, is---

(a) considering a complaint;

(b) considering any information;

(c) conducting an inquiry; or

(d) conducting a review,

a member of the board---

(i) gives a notice of resignation; or

(ii) ceases to be a member by reason of the expiry of his term of office or other circumstances referred to in section 21,the member may continue to be a member of that board for the purpose of completing the performance of his function in respect of paragraph (a), (b), (c) or (d), as the case may be.

23. Board secretary and legal adviser


(1) On each board, there shall be---

(a) a board secretary; and

(b) a legal adviser who shall be a solicitor or counsel.

(2) The persons specified in subsection (1)(a) and (b) shall be appointed by the Secretary.

24. Functions of boards

(1) The functions of the Practitioners Board and the Medicines Board are set out in Parts I and II of Schedule 3 respectively.

(2) The Secretary may, after consultation with the Council, by order published in the Gazette, amend Schedule 3.

PART IV
Committees of the Chinese Medicine Practitioners Board
and the Chinese Medicines Board

25. Committees of boards to be set up

(1) The Council shall establish---

(a) under the Practitioners Board, the following committees---

(i) the Registration Committee;

(ii) the Examination Committee; and

(iii) the Disciplinary Committee of Chinese Medicine Practitioners;

(b) under the Medicines Board, the following committees---

(i) the Chinese Medicines Committee;

(ii) the Chinese Medicines Traders Committee; and

(iii) the Regulatory Committee of Chinese Medicines Traders,

and these committees shall have the functions specified in Parts I, II, III, IV, V and VI of Schedule 4 respectively.

(2) The Secretary may, after consultation with the Council, by order published in the Gazette, amend Schedule 4.

26. Registration Committee

The Registration Committee shall consist of the following members, each of whom shall be nominated by the Practitioners Board and appointed by the Council---

(a) a chairman who shall be a member of the Practitioners
Board;

(b) 5 Chinese medicine practitioners; and

(c) 1 person from an educational institution in Hong Kong.

27. Examination Committee

The Examination Committee shall consist of the following members, each of whom shall be nominated by the Practitioners Board and appointed by the Council---

(a) a chairman who shall be a member of the Practitioners
Board;

(b) 4 Chinese medicine practitioners; and

(c) 2 persons from educational institutions in Hong Kong.

28. Disciplinary Committee of Chinese
Medicine Practitioners

The Disciplinary Committee of Chinese Medicine Practitioners shall consist of the following members, each of whom shall be nominated by the Practitioners Board and appointed by the Council---

(a) a chairman who shall be a member of the Practitioners Board;

(b) a deputy chairman who shall be a member of the Practitioners Board;

(c) 4 Chinese medicine practitioners; and

(d) 1 person who shall be a lay member of the Practitioners Board.

29. Chinese Medicines Committee

The Chinese Medicines Committee shall consist of the following members---

(a) 1 public officer who shall be appointed by the Director;

(b) the Government Chemist or his representative; and

(c) the following persons, each of whom shall be nominated by the Medicines Board and appointed by the Council---

(i) a chairman who shall be a member of the Medicines Board;

(ii) 2 persons from the trade of Chinese medicines;

(iii) 1 Chinese medicine practitioner; and

(iv) 1 person from an educational institution in Hong Kong.

30. Chinese Medicines Traders Committee

The Chinese Medicines Traders Committee shall consist of the following members---

(a) 2 public officers who shall be appointed by the Director; and

(b) the following persons, each of whom shall be nominated by the Medicines Board and appointed by the Council---

(i) a chairman who shall be a member of the Medicines Board;

(ii) 2 persons from the trade of Chinese medicines;

(iii) 1 Chinese medicine practitioner; and

(iv) 1 lay person.

31. Regulatory Committee of Chinese

Medicines Traders

The Regulatory Committee of Chinese Medicines Traders shall consist of the following members---

(a) 1 public officer who shall be appointed by the Director; and

(b) the following persons, each of whom shall be nominated by the Medicines Board and appointed by the Council---

(i) a chairman who shall be a member of the Medicines Board;

(ii) a deputy chairman who shall be a member of the Medicines Board;

(iii) 2 persons from the trade of Chinese medicines;

(iv) 1 Chinese medicine practitioner; and

(v) 1 person who shall be a lay member of the Medicines Board.

32. Provisions applicable to Disciplinary Committee
of Chinese Medicine Practitioners
and Regulatory Committee of
Chinese Medicines Traders

(1) If during the period when the Disciplinary Committee of Chinese Medicine Practitioners or the Regulatory Committee of Chinese Medicines Traders, as the case may be, is considering any complaint or information, a member of the committee---

(a) gives a notice of resignation; or

(b) ceases to be a member by reason of the expiry of his term of office or other circumstances referred to in section 38,

the member may continue to be a member of that committee for the purpose of completing the performance of his function in respect of that complaint or information.

(2) At a meeting of the Disciplinary Committee of Chinese Medicine Practitioners or the Regulatory Committee of Chinese Medicines Traders, as the case may be, the chairman or, in his absence, the deputy chairman, shall preside.

(3) Notwithstanding subsection (2), if both the chairman and the deputy chairman declare their interest in respect of a particular case which is to be considered at a meeting, neither of them may preside or sit at the meeting and the members present (including the chairman and the deputy chairman) shall elect another member to preside at the meeting.

(4) The quorum of a meeting is 3, subject to 1 of whom being a lay member.

(5) In considering a case which has been brought to the attention of---

(a) the Disciplinary Committee of Chinese Medicine Practitioners for considering whether the Practitioners Board should be recommended to hold an inquiry; or

(b) the Regulatory Committee of Chinese Medicines Traders for making suitable recommendations to the Medicines Board,

both committees shall act in accordance with the prescribed procedure.

(6) Where the Disciplinary Committee of Chinese Medicine Practitioners or the Regulatory Committee of Chinese Medicines Traders, as the case may be, is considering any complaint or information received in respect of a particular case and a member of the committee is subject of such complaint or information---

(a) the member shall not take part in the consideration of such complaint or information or attend any meeting held for such purposes;

(b) the Council shall at the same time appoint a temporary member; and

(c) the committee shall consider the complaint or information afresh.

33. Terms of appointment to committees
under this Part

(1) Subject to subsection (3), a member appointed under this Part shall hold office for such period not exceeding 3 years as may be specified in the letter of his appointment.

(2) The member may, upon the expiry of his term of office, be reappointed.

(3) A member appointed or reappointed under this Part may, at any time before the expiry of his term of office, resign his office by giving notice in writing---

(a) in the case of a member other than the chairman of a committee, to the chairman of the committee;

(b) in the case of the chairman of a committee, to the Council.

34. Replacement members

Where, before the expiry of his term of office, a member of a committee under this Part resigns or his office becomes vacant, the Council may appoint a person who is suitably qualified for appointment to hold office in place of that member until the expiry of the period for which he was appointed.

35. Vacation of office

Where---

(a) a member of a committee under this Part---

(i) is sentenced to imprisonment, whether suspended or not, for any offence by any court or magistrate in Hong Kong or elsewhere;

(ii) is the subject of an order made under section 98; or

(iii) becomes bankrupt or enters into a composition or scheme of arrangement with his creditors within the meaning of the Bankruptcy Ordinance (Cap. 6); or

(b) the Council---

(i) is satisfied that a member of a committee under this Part is no longer ordinarily resident in Hong Kong; or

(ii) is of the opinion that a member of a committee under this Part is unable or unfit to perform his duties and exercise his powers as a member of the committee, the Council may declare his office as a member of the committee to be vacant, and shall notify the fact in such manner as the Council thinks fit; and upon such declaration the office shall become vacant.

36. Temporary members

(1) If a member of a committee under this Part is for any reason unable to perform his duties and exercise his powers as such member for any period, the Council may appoint another person suitably qualified for appointment to be a temporary member in place of the member during that period.

(2) While any person is acting as a temporary member after appointment to such membership under subsection (1), he shall be capable of performing all the duties and of executing all the powers of the member whom he is temporarily replacing.

37. Disqualification

Notwithstanding anything in the foregoing provisions, a person---

(a) against whom an order under section 98 has at any time been made;

(b) who is---

(i) undergoing a sentence of imprisonment;

(ii) an undischarged bankrupt;

(iii) not ordinarily resident in Hong Kong; or

(c) whom the Council considers unfit for appointment, shall not be eligible for appointment or reappointment, as the case may be, as a member of a committee under this Part.

38. Cessation of membership

If during the period of his office, a member of a committee under this Part who is not a member of a board when appointed under section 26, 27, 28, 29, 30 or 31, as the case may be, becomes a member of a board, he ceases to be a member of that committee.

PART V
Miscellaneous Committees

39. Establishment of committees

In addition to the power to establish committees under section 25, the Council may, upon the recommendation of the Practitioners Board or the Medicines Board---

(a) establish a committee or committees of the board for the purposes of performing such functions as may be prescribed by the Council; and

(b) vary, modify or extend the functions of such committee or committees.

40. Appointment to committees

(1) Subject to subsection (2) and section 41, the Council may appoint members of the boards, and persons who are not such members, to be members of a committee.

(2) The Council shall not appoint to any committee a person against whom an order under section 98 has at any time been made.

(3) A member appointed to a committee may, at any time before the expiry of his term of office, resign his office by giving notice in writing to the Council.

41. Chairmen of committees

(1) Subject to subsection (2), the Council may appoint a person to be the chairman of a committee.

(2) Only a member of a board is eligible to be appointed as the chairman of a committee.

(3) Unless a contrary intention appears in the context, a reference to a member of a committee includes a reference to the chairman of the committee. 42. Legal adviser to committees

(1) A committee may have a legal adviser who shall be a solicitor or counsel.

(2) A legal adviser shall be appointed by the Secretary.

43. Dissolution of committees

The Council may, at any time, upon the recommendation of a board, dissolve a committee of the board established under section 39.

44. Application of provisions

Unless a contrary intention appears in the context, sections 40, 41 and 42 shall apply to a committee established under section 25 as they apply to a committee established under section 39.

PART VI
Meetings

45. Meetings

(1) The Council, a board or committee shall meet at such times and such places as the Chairman or the chairmen of the respective boards or committees may appoint.

(2) The Chairman or the chairman of a board or committee shall, on a requisition signed by not less than such number of members being a number forming the quorum of the Council, board or committee, as the case may be, summon a meeting of the Council, board or committee, as the case may be, and appoint the time and place for the meeting.

46. Validity of proceedings

The validity of any proceedings of the Council, a board or committee shall not be affected by any defect in the appointment of any member of the Council, board or committee or by any vacancy among the members of the Council, board or committee, as the case may be.

47. Questions to be decided by majority

All questions coming or arising before the Council, a board or committee shall be decided by a majority of votes of members present at a meeting and voting thereon, and in the case of an equality of votes, the Chairman or the chairman of the board or committee shall have a casting vote in addition to his original vote.

48. Transaction of business by
circulation of papers

The Council, a board or committee may transact any of its business by circulation of papers, and a resolution in writing which is signed by all the members of the Council, board or committee for the time being present in Hong Kong (being not less than the number required to constitute a majority of the Council, board or committee, as the case may be,) shall be as valid and effectual as if it had been passed at a meeting by the votes of the members so signing.

49. Standing orders relating to meetings

The Council, a board or committee may, subject to this Ordinance, make standing orders---

(a) governing its procedure in the transaction of business;

(b) regulating the procedure at, and in connection with its meetings including the election of a temporary chairman at a meeting and the casting of votes for the determination of any questions coming or arising before its meeting;

(c) specifying the circumstances under which invitees may attend or make representations at its meetings;

(d) governing the declaration of interest by its chairman and members.

50. Application of Part VII of Interpretation
and General Clauses Ordinance

For the avoidance of doubt, Part VII of the Interpretation and General Clauses Ordinance (Cap. 1) applies to the Council, a board or committee and appointments to the Council, board or committee except in so far as it is inconsistent with this Ordinance.

PART VII
Registration of Chinese Medicine Practitioners
Register

51. Registrar

For the purpose of this Ordinance, there shall be a Registrar of Chinese Medicine Practitioners who shall be the Director or his designated representative.

52. Register

(1) The Registrar shall cause a register, to be called the Register of Chinese Medicine Practitioners, to be kept in such form as he may determine, containing the names, addresses and qualifications and such other particulars of all persons who are registered under section 69 or 85 as the Registrar considers appropriate.

(2) The Registrar may maintain separate parts under the Register in respect of persons registered under section 69 or 85.

(3) The Registrar is responsible for the maintenance and custody of the Register. 53. Publication of Register and evidence of registration, etc.

(1) The Registrar shall publish in the Gazette once every 12 months a list of the names and addresses of all persons whose names appear in the Register.

(2) The publication of the list referred to in subsection (1) shall be prima facie evidence that each person named in the list is registered.

(3) A certificate under the hand of the Registrar stating that the name of a person is at any date or was at any date registered in the Register shall be conclusive evidence in all courts of law of the facts stated in such certificate.

54. Alterations to Register

The Registrar may, upon application by a registered Chinese medicine practitioner, amend any entry in the Register as to the address or qualifications of or any other particulars relating to the registered Chinese medicine practitioner, if he is satisfied that such amendment is necessary for the purposes of maintaining the accuracy of the Register.

55. Powers of Practitioners Board to direct
or order alterations to Register

If, in the exercise of its powers under the Ordinance, the Practitioners Board directs or orders that any alterations be made to the Register, the Registrar shall make such alterations as directed or ordered.

56. Powers of Practitioners Board to order
removal of names from Register

(1) The Practitioners Board may order the removal from the Register the name of any person who---

(a) has requested in writing that his name be removed;

(b) is deceased;

(c) by reason of health, in its opinion, is unfit to practise Chinese medicine;

(d) being a person required to be the holder of a practising certificate under section 76, has not obtained such a certificate for a period exceeding 6 months since he was first registered under this Ordinance or since the expiry of a practising certificate issued to him under section 76;

(e) is subject of an order made under section 98(3)(a), (b) or (c); or

(f) has failed to supply the Registrar with an address in Hong Kong at which notices may be served on him.

(2) For the purpose of subsection (1)(f), any person who fails to acknowledge within 4 months after the date of dispatch the receipt of a registered letter addressed to him at his address as recorded in the Register, or the last address in Hong Kong supplied by him to the Registrar shall be deemed to have failed to supply the Registrar with an address in Hong Kong.

57. Service of notice and order of
removal from Register

(1) Where the Practitioners Board intends to order the removal from the Register the name of a Chinese medicine practitioner under section 56(1)(c), (d) or (f), it shall serve a notice on the Chinese medicine practitioner stating the reasons for its intention to make the order and inviting him to give any written representations to the Practitioners Board.

(2) Where an order is made under section 56(1)(c), (d) or (f), the Registrar shall serve a copy of the order on the Chinese medicine practitioner concerned.

58. Restoration to Register

(1) Any person whose name has been removed under the provisions of this Ordinance from the Register may apply to the Practitioners Board for the restoration of his name to the Register.

(2) An application under subsection (1) shall be made in such form and accompanied by such documents and particulars as the Practitioners Board may determine.

(3) Without prejudice to the generality of subsection (2), the Practitioners Board may request an applicant to submit a declaration as to---

(a) whether he has been convicted in Hong Kong or elsewhere of any offence punishable with imprisonment since his name---

(i) was first entered on the Register; and

(ii) was removed from the Register;

(b) whether he has been found guilty in Hong Kong or elsewhere of misconduct in a professional respect since his name---

(i) was first entered on the Register; and

(ii) was removed from the Register;

(c) in the case of his having been so convicted or having been so found guilty of misconduct, the place and nature of each such offence or record of misconduct, as the case may be;

(d) whether there are outstanding legal proceedings against him at the time of the application.

(4) In considering an application for restoration, the Practitioners Board may, in its absolute discretion and after such inquiry as may be necessary, either allow or refuse the application.

(5) If the Practitioners Board allows an application, it---

(a) shall direct the Registrar, on payment of a prescribed fee by the applicant, to restore the name of the applicant to the Register and the Registrar shall restore the name as directed; and

(b) may determine that the restoration is subject to such conditions as it considers desirable.

Licensing Examination

59. Practitioners Board to set and conduct
Licensing Examination

(1) The Practitioners Board shall set and conduct an examination, called the Chinese Medicine Practitioners Licensing Examination, the passing of which shall qualify a person under section 67(a) to apply to be registered as a registered Chinese medicine practitioner in Hong Kong.

(2) Without prejudice to section 61, the Practitioners Board may impose such conditions as it thinks fit, being conditions which are relevant to the assessment or improvement of a person's professional knowledge and practice in Chinese medicine and which a person must comply with before the Practitioners Board allows him to undertake the Licensing Examination.

60. Practitioners Board to determine
syllabus, etc.

The Practitioners Board shall determine the examination syllabus, format, standard of assessment and other related matters in respect of the Licensing Examination.

61. Eligibility for undertaking
Licensing Examination

(1) A person shall be eligible to undertake the Licensing Examination if---

(a) he satisfies the Practitioners Board that at the time of the application he has satisfactorily completed such undergraduate degree course of training in Chinese medicine practice or its equivalent as is approved by the Practitioners Board; or

(b) he is a person whose name is entered on the list maintained under section 90 and is required to undertake the Licensing Examination under section 95.

(2) Any person who seeks to undertake the Licensing Examination under subsection

(1)(a) shall---

(a) make an application to the Practitioners Board in such form as may be determined by the Practitioners Board; and

(b) pay a prescribed application fee.

62. Notification and review, etc. of results of
Licensing Examination

(1) Where a Licensing Examination is conducted under section 59, the Practitioners Board shall notify the person who undertook the Examination in writing of the relevant result.

(2) Within 14 days of the receipt of the written notification made in accordance with subsection (1), the person may request, in writing stating the reasons relied upon, the Practitioners Board to review the result of the Licensing Examination, to which the written notification relates.

(3) Upon receipt of a request for review under subsection (2) and payment of a prescribed review fee, the Practitioners Board shall review the result and notify the person in writing of its decision within 1 month after the completion of the review.

63. Certificate of passing Licensing Examination

The Practitioners Board may issue a certificate to a person who has passed the Licensing Examination.

64. Restriction on number of attempts

(1) The Practitioners Board may restrict the number of consecutive attempts which a person may make in respect of the Licensing Examination.

(2) The Practitioners Board shall publish such number of consecutive attempts referred to in subsection (1) as it may determine by notice in the Gazette.

(3) For the avoidance of doubt, the notice published under subsection (2) is not subsidiary legislation.

65. Fees payable in respect of
Licensing Examination

(1) Any person who undertakes the Licensing Examination shall pay a prescribed fee before he may take the Examination.

(2) Different fees shall be payable in respect of different parts of the Licensing Examination, where applicable.

66. Review of decision in relation to
Licensing Examination

(1) Where the powers under sections 59(2), 61(1)(a) and 63 have been delegated to the Examination Committee pursuant to section 156, any person aggrieved by its decision made in pursuance of the powers conferred on it may request the Practitioners Board to review the decision of the Examination Committee.

(2) A request for a review under subsection (1) shall be in writing stating the reasons relied upon and shall be made to the Practitioners Board within 14 days of the receipt of the notification of the decision of the Examination Committee.

(3) Upon receipt of the request, the Practitioners Board shall review the decision of the Examination Committee, and shall notify the person concerned of its decision in writing.

(4) A review under this section shall be conducted in accordance with the prescribed procedure.

Registration

67. Qualifications for registration
under section 69

A person is qualified to apply to be registered as a registered Chinese medicine practitioner under section 69 if---

(a) he has passed the Licensing Examination; or

(b) the Practitioners Board has determined that he is so qualified under section 92.

68. Application for registration

(1) Any person qualified to apply to be registered as a registered Chinese medicine practitioner may apply to the Practitioners Board within such period of time as may be determined by the Practitioners Board.

(2) An application under subsection (1) shall be accompanied by---

(a) such documents and particulars as may be determined by the Practitioners Board; and

(b) a prescribed application fee.

(3) Without prejudice to the generality of subsection (2)(a), the Practitioners Board may require a person who applies for registration to submit with his application---

(a) a declaration as to---

(i) whether he has been convicted in Hong Kong or elsewhere of any offence punishable with imprisonment; and if he has been so convicted, the place and nature of each such offence; and

(ii) whether he has been found guilty in Hong Kong or elsewhere of misconduct in a professional respect; and if he has been so found guilty, the place and nature of each such record of misconduct; and

(b) in the case of section 67(b), such evidence from the person regarding his claim of experience, qualifications, knowledge or skill in the practice of Chinese medicine as the Practitioners Board considers appropriate.

(4) The Practitioners Board may require an applicant to submit such further information or particulars as the Practitioners Board considers necessary to enable it to determine the application for registration.

69. Registration

(1) The Practitioners Board may, subject to sections 70 and 71 and the recommendation of the Registration Committee, approve an application for registration as a registered Chinese medicine practitioner under section 68.

(2) Upon approving an application for registration under subsection (1), the Practitioners Board shall direct the Registrar to enter the name of the person on the Register.

70. Refusal of application for registration

(1) The Practitioners Board may, subject to section 71, refuse to approve the application of a person for registration if it is satisfied---

(a) after due inquiry, that the person has been convicted in Hong Kong or elsewhere of any offence punishable with imprisonment;

(b) after due inquiry, that the person has been found guilty in Hong Kong or elsewhere of misconduct in a professional respect;

(c) that the person is not qualified to be registered; or

(d) that the person has sought to obtain registration by fraud or misrepresentation.

(2) Where the Practitioners Board refuses an application, the Secretary of the Practitioners Board shall notify the applicant in writing of the decision and the reasons of refusal.

71. Cases involving previous conviction
and professional misconduct

(1) If a person who applies under section 68(1) has declared that he has been convicted in Hong Kong or elsewhere of an offence punishable with imprisonment or that he has been found guilty in Hong Kong or elsewhere of misconduct in a professional respect, the Practitioners Board shall refer his case to the Disciplinary Committee of Chinese Medicine Practitioners.

(2) Where, pursuant to the consideration and recommendation by the Disciplinary Committee of Chinese Medicine Practitioners, the Practitioners Board considers that the person is suitable for registration under section 69, the Practitioners Board may approve the application.

72. Certificate of registration

Where a person has been registered as a registered Chinese medicine practitioner under section 69, the Registrar shall issue to him a certificate of registration in such form as may be determined by the Practitioners Board.

73. Certificate verifying registration
and certificate of standing

(1) The Practitioners Board may, upon application by a person whose name appears in the Register, issue---

(a) a certificate verifying registration; or

(b) a certificate of standing which shows the disciplinary record, if any, of that person.

(2) A prescribed fee shall be payable in respect of each certificate referred to in subsection (1)(a) and (b).

74. Title of registered Chinese
medicine practitioners

(1) A registered Chinese medicine practitioner is entitled to be known in the English language as "registered Chinese medicine practitioner of the Chinese Medicine Council of Hong Kong" or the abbreviation "registered Chinese medicine practitioner" and in the Chinese language as "香港中醫藥管理委員會註冊中醫" or "香港中醫藥管理委員會註冊中醫師" or the abbreviation "註冊中醫" or "註冊中醫師".

(2) In addition to the titles provided under subsection (1), a registered Chinese medicine practitioner may use the following addition or description to indicate his stream of practice in Chinese medicine---

(a) general practice (全科);

(b) acupuncture (針灸);

(c) bone-setting (骨傷).

75. Privileges of registered and listed
Chinese medicine practitioners

(1) Subject to section 76, every registered Chinese medicine practitioner and listed Chinese medicine practitioner shall be entitled to practise Chinese medicine and to recover in any court---

(a) reasonable charges for professional aid, advice and visits; and

(b) the value of any Chinese herbal medicines or proprietary Chinese medicines or any Chinese medical appliances made or supplied by him to his patients.

(2) No person shall be entitled to recover in any court any such charges as are referred to in subsection (1) unless at the date when such charges accrued he was a registered Chinese medicine practitioner or listed Chinese medicine practitioner.

Practising Certificate

76. Registered Chinese medicine practitioner not to practise without practising certificate

(1) A registered Chinese medicine practitioner other than one registered under section 85 shall not practise Chinese medicine unless he is the holder of a practising certificate which is then in force.

(2) An application for the issue or renewal of a practising certificate may be made by a registered Chinese medicine practitioner to the Registrar in writing and shall be accompanied by---

(a) a prescribed fee; and

(b) a declaration as to---

(i) whether he has been convicted in Hong Kong or elsewhere of any offence punishable with imprisonment---

(A) since his registration; or

(B) since the last renewal of his practising certificate,
as the case may be;

(ii) whether he has been found guilty in Hong Kong or elsewhere of misconduct in a professional respect---

(A) since his registration; or

(B) since the last renewal of his practising certificate,
as the case may be;

(iii) in the case of his having been so convicted or so found guilty of misconduct, the place and nature of each such offence or record of misconduct, as the case may be; and

(c) in the case of renewal, such documents or certificates in relation to continuing education in Chinese medicine as may be required by the Practitioners Board.

(3) Upon receipt of an application under subsection (2), the Registrar may issue or renew the practising certificate specifying such conditions or restrictions as may be imposed if---

(a) the declaration referred to in subsection (2)(b) states to the effect that the registered Chinese medicine practitioner---

(i) has not been convicted in Hong Kong or elsewhere of any offence punishable with imprisonment; and

(ii) has not been found guilty in Hong Kong or elsewhere of misconduct in a professional respect; and

(b) the documents or certificates referred to in subsection (2)(c) show that the registered Chinese medicine practitioner has complied with the requirements determined by the Practitioners Board under section 82.

77. Cases involving previous convictions
and professional misconduct

(1) If a registered Chinese medicine practitioner makes a declaration as required under section 76(2)(b) and declares that he has been convicted in Hong Kong or elsewhere of an offence punishable with imprisonment or that he has been found guilty in Hong Kong or elsewhere of misconduct in a professional respect, the Registrar shall refer his case to the Disciplinary Committee of Chinese Medicine Practitioners.

(2) Where, pursuant to the consideration and recommendation by the Disciplinary Committee of Chinese Medicine Practitioners, the Practitioners Board directs that the registered Chinese medicine practitioner be issued with a practising certificate or be granted with a renewal, as the case may be, the Registrar shall issue or renew the certificate specifying such conditions or restrictions as may be imposed.

78. Currency of a practising certificate

(1) Subject to subsection (2), a practising certificate shall be in force for such period not exceeding 3 years as may be specified in the certificate.

(2) If at any time during the currency of a practising certificate, the holder of the certificate ceases to be a registered Chinese medicine practitioner, the certificate shall thereupon be deemed cancelled.

79. Obligations of practising
certificate holders

If at any time during the currency of a practising certificate, the holder of the practising certificate---

(a) is convicted in Hong Kong or elsewhere of an offence punishable with imprisonment, he shall report the conviction to the Registrar;

(b) is found guilty in Hong Kong or elsewhere of misconduct in a professional respect, he shall disclose the record of misconduct to the Registrar.

80. Deeming provision in relation to
practising certificate

(1) Any person who is required to be the holder of a practising certificate under section 76 shall be deemed to have obtained the practising certificate when he has duly applied to the Registrar and paid the prescribed fee in accordance with section 76(2).

(2) Subsection (1) shall cease to apply once the application to the Registrar is approved or refused.

(3) Notwithstanding subsection (1), a person who is required to be the holder of a practising certificate shall not be entitled to recover any fees, costs or other remuneration in his capacity as a registered Chinese medicine practitioner unless he was, at the time when the cause of action arose, the holder of a valid practising certificate.

81. Recovery of fees for practising
certificates

(1) If any registered Chinese medicine practitioner contravenes section 76(1), the amount of the prescribed fee payable by him under section 76(2) shall be recoverable as a civil debt by claim made in the name of the Registrar.

(2) In any proceedings under this section a certificate purporting to be under the hand of the Registrar to the effect that the registered Chinese medicine practitioner concerned has not paid the prescribed fee shall, until the contrary is proved, be evidence of non-payment of the fee.

(3) On recovery from a Chinese medicine practitioner of a prescribed fee under this section, the Registrar may, subject to the Chinese medicine practitioner's name appearing on the Register and where applicable, subject to section 77, issue the Chinese medicine practitioner with the practising certificate.

82. Continuing education in Chinese medicine

(1) The Practitioners Board may, on the advice of the Registration Committee, make arrangements for the accreditation of continuing education in Chinese medicine, either on its own or in conjunction with any other person or educational institution.

(2) The Practitioners Board shall determine the requirements relating to continuing education in Chinese medicine which are to be complied with before a practising certificate may be renewed under section 76 or 77.

PART VIII
Limited Registration

83. Limited registration

Where an educational or scientific research institution intends to engage a person---

a) who does not have any of the qualifications for registration referred to in section 67; or

(b) who has a qualification that qualifies him to apply to be registered but it is impracticable for him to obtain registration under section 69 in the circumstances, to perform predominantly clinical teaching or research in Chinese medicine for the institution, the institution may apply to the Practitioners Board on behalf of the person for limited registration of that person.

84. Application for limited registration

(1) An application for limited registration shall be made to the Practitioners Board in such form as the Practitioners Board may determine and shall be accompanied by---

(a) such documents and particulars as may be determined by the Practitioners Board; and

(b) a prescribed application fee.

(2) For the purpose of determining an application for limited registration, the Practitioners Board may request the person on whose behalf the application is made to submit a declaration stating the same particulars as are required under section 68(3)(a).

85. Approval of limited registration

(1) Upon receipt of an application made under section 84(1), the Practitioners Board may refer the application to the Registration Committee.

(2) The Registration Committee may, and if so directed by the Practitioners Board shall, make a report to the Practitioners Board.

(3) In any report made to the Practitioners Board under subsection (2), the Registration Committee shall make recommendations to the Practitioners Board as to whether the application should be approved.

(4) Where the Practitioners Board is satisfied---

(a) that the application for limited registration is made by an educational or scientific research institution; and

(b) that the person on whose behalf the application was made---

(i) has satisfactorily completed such undergraduate degree course of training in Chinese medicine practice or its equivalent as is acceptable to the Practitioners Board; and

(ii) possesses adequate and relevant full-time experience in Chinese medicine practice,

the Practitioners Board may, if the Registration Committee so recommends, direct that the person be registered as a Chinese medicine practitioner with limited registration subject to such conditions and restrictions regarding his practice as may be imposed by the Practitioners Board.

86. Limits of limited registration

The limits of a person's registration under section 85 shall be defined in the direction under the same section by specifying---

(a) a period, not exceeding 1 year, as the period for which the registration is to have effect;

(b) the name of the educational or scientific research institution in respect of which the registration has effect;

(c) the employment for performing predominantly clinical teaching or research in Chinese medicine in the named institution; and

(d) such conditions and restrictions regarding the practice of the Chinese medicine practitioner with limited registration, if any, as may be specified by the Practitioners Board.

87. Certificate of limited registration

When an application for limited registration is approved under section 85, the Registrar shall register the person on whose behalf the application was made in the Register and issue to him a certificate of limited registration in such form as may be determined by the Practitioners Board.

88. Refusal of application for
limited registration

(1) The Practitioners Board may refuse an application for limited registration or renewal of such registration if it is satisfied---

(a) that the requirements of section 85 have not been complied with;

(b) after due inquiry, that the person on whose behalf the application was made---

(i) has been convicted in Hong Kong or elsewhere of any offence punishable with imprisonment; or

(ii) has been found guilty in Hong Kong or elsewhere of misconduct in a professional respect;

(c) that the institution which made the application or the person on whose behalf the application was made has sought to obtain registration by fraud or misrepresentation; or

(d) that it is reasonable in all circumstances to do so.

(2) Where the Practitioners Board refuses an application, the secretary of the Practitioners Board shall notify the institution which made the application and the person on whose behalf the application was made in writing of the decision and the ground for refusal.

89. Provisions relating to renewal
of limited registration

(1) Where an educational or scientific research institution which made an application under section 83 applies for renewal of registration, such registration shall, if the Practitioners Board so approves, be renewed---

(a) for a period not exceeding 1 year from the expiry of the current registration;

(b) for the purposes of the clinical teaching or research in Chinese medicine in the educational or scientific research institution specified under sections 86(b) and (c); and

(c) subject to such conditions or restrictions regarding the practice of the Chinese medicine practitioner with limited registration, if any, as may be specified by the Practitioners Board.

(2) Upon the approval of the Practitioners Board for the renewal of limited registration, a new certificate of limited registration may be issued by the Registrar on payment of a prescribed fee.

PART IX

Transitional Arrangements for Chinese

Medicine Practitioners

90. List maintained by Practitioners Board

(1) The Practitioners Board shall compile and maintain a list of Chinese medicine practitioners and shall enter on such list the name of any person who---

(a) is practising Chinese medicine on 3 January 2000;

(b) has applied to the Practitioners Board for his name to be included in the list; and

(c) has paid a prescribed fee.

(2) A person whose name is entered on the list under this section shall be assessed by the Practitioners Board as to whether he satisfies the requirements under section 92.

(3) A person referred to in subsection (2) may---

(a) continue practising Chinese medicine, subject to such conditions and restrictions as may be imposed and notified in writing by the Practitioners Board; and

(b) use the title of "Chinese medicine practitioner" in the English language and "中醫" or "中醫師" in the Chinese language,

until---

(i) his name has been entered on the Register under section 69(2);

(ii) his application for registration, if any, has been refused under section 70;

(iii) his name has been removed from the list under section 91; or

(iv) such date as may be specified and promulgated by the Secretary by notice in the Gazette,

whichever is the earliest.

(4) Where the Practitioners Board has imposed conditions or restrictions under subsection (3)(a), it may amend, vary or revoke any of such conditions or restrictions.

(5) The list maintained under this section shall remain open for application for inclusion by Chinese medicine practitioners within such period of time as may be determined by the Practitioners Board.

(6) The Practitioners Board may arrange to publish in the Gazette from time to time as it thinks appropriate the list maintained by it under this section.

(7) Nothing in this section shall operate so as to prohibit any person who was practising Chinese medicine immediately prior to the commencement of this provision from continuing to practise in accordance with this Ordinance until after the expiry of the period of time referred to in subsection (5).

(8) Where a person who continues to practise Chinese medicine by virtue of subsection (7) would, but for this subsection, be liable to be prosecuted for an offence under section 108(1)(c) and (2), then the person shall not be so liable until after the expiry of the period of time referred to in subsection (5) notwithstanding that on the expiry of such period of time, no application under subsection (1)(b) has been made to the Practitioners Board.

91. Removal from the list

(1) The Practitioners Board shall remove from the list maintained under section 90 the name of a person---

(a) who becomes registered under section 69; or

(b) whose application for registration, if any, is refused under section 70.

(2) The Practitioners Board may remove from the list maintained under section 90 the name of a person who---

(a) is subject to the conditions or restrictions imposed under section 90(3)(a) but has failed to comply with any of such conditions or restrictions; or

(b) has been convicted in Hong Kong or elsewhere of an offence punishable with imprisonment.

(3) The Practitioners Board shall notify the person concerned in writing of the reasons for its direction under subsection (2).

92. Alternative qualifying requirements

(1) The Practitioners Board may determine a person to be qualified to be registered under section 69 if it is satisfied, after assessment, that the person---

(a) is one whose name is entered on the list maintained under section 90; and

(b) has acquired substantial experience, knowledge and skills in the practice of Chinese medicine.

(2) No person shall be regarded as having acquired substantial experience, knowledge and skills for the purpose of subsection (1)(b) unless he has---

(a) attained the standard which qualifies him to be exempted from the Licensing Examination under section 93;

(b) passed the registration assessment as required under section 94; or

(c) passed the Licensing Examination as required under section 95.

93. Exemptions from Licensing Examination

A listed Chinese medicine practitioner who satisfies the Practitioners Board that he has fulfilled either one of the following criteria, namely--- (a) immediately before 3 January 2000, he has been practising Chinese medicine in Hong Kong for a continuous period of not less than 15 years; or

(b) (i) immediately before 3 January 2000, he has been practising Chinese medicine in Hong Kong for a continuous period of not less than 10 years; and

(ii) he has obtained a qualification in Chinese medicine practice acceptable to the Practitioners Board,

shall be exempted from the Licensing Examination.

94. Registration assessment

(1) A listed Chinese medicine practitioner who satisfies the Practitioners Board that he has fulfilled either one of the following criteria, namely---

(a) immediately before 3 January 2000, he has been practising Chinese medicine in Hong Kong for a continuous period of not less than 10 years; or

(b) (i) immediately before 3 January 2000, he has been practising Chinese medicine in Hong Kong for a continuous period of less than 10 years; and

(ii) he has obtained a qualification in Chinese medicine practice acceptable to the Practitioners Board,

shall be exempted from the Licensing Examination but shall be required to pass a registration assessment conducted by the Practitioners Board before he is qualified to apply to be registered as a registered Chinese medicine practitioner under section 69.

(2) A listed Chinese medicine practitioner who is required to undergo the registration assessment shall pay a prescribed fee before he may attend the registration assessment.

95. Requirement to undertake Licensing

Examination

(1) A listed Chinese medicine practitioner who---

(a) satisfies the Practitioners Board that immediately before 3 January 2000, he has been practising Chinese medicine in Hong Kong for a continuous period of less than 10 years; or

(b) has failed the registration assessment,

shall be required to undertake the Licensing Examination, the passing of which shall qualify him to apply to be registered as a registered Chinese medicine practitioner under section 69.

(2) Notwithstanding subsection (1)(b), a listed Chinese medicine practitioner who has made a request for review under section 96 shall not be required to undertake the Licensing Examination pending the outcome of the review.

96. Notification and review, etc.

(1) Where a registration assessment is conducted under section 94, the Practitioners Board shall notify the listed Chinese medicine practitioner concerned in writing of the relevant result.

(2) Within 14 days of the receipt of the written notification made in accordance with subsection (1), the listed Chinese medicine practitioner concerned may request the Practitioners Board to review the result of the registration assessment, to which the written notification relates, by submitting the request in writing and stating the reasons relied upon.

(3) Upon receipt of a request for review under subsection (2) and payment of a prescribed review fee, the Practitioners Board shall review the result and notify the listed Chinese medicine practitioner in writing of its decision within 1 month after the completion of the review.

PART X

Appeals, Disciplinary Powers and Inquiries

97. Appeals

(1) Any person aggrieved by a decision of the Practitioners Board made under sections 58(4), 59(2), 61(1)(a), 62, 63, 64, 66, 70 and 88 may, within 14 days of the receipt of the notification of the decision, appeal against that decision to the Council in writing stating the reasons relied upon.

(2) In determining an appeal under subsection (1), the Council may invite the person concerned to give further representations in writing or in person.

(3) For the purpose of hearing an appeal, 5 members of the Council shall be a quorum.

(4) A hearing of an appeal shall be conducted in accordance with the prescribed procedure.

(5) The Council may affirm, reverse or vary the decision appealed against.

(6) The decision of the Council under subsection (5) shall be final.

98. Disciplinary powers of Practitioners Board

(1) Where the Disciplinary Committee of Chinese Medicine Practitioners considers that the conduct of a registered Chinese medicine practitioner should be inquired into as a result of a complaint being made to it or otherwise, the Disciplinary Committee of Chinese Medicine Practitioners shall refer the case to the Practitioners Board.

(2) Where the Practitioners Board is satisfied, after due inquiry into the case referred to it under subsection (1), that the registered Chinese medicine practitioner---

(a) has been convicted in Hong Kong or elsewhere of any offence punishable with imprisonment;

(b) has been found guilty in Hong Kong or elsewhere of misconduct in any professional respect;

(c) has obtained registration by fraud or misrepresentation;

(d) was not at the time of his registration qualified to be registered;

(e) has breached a condition or conditions imposed by the Practitioners Board on his practice of Chinese medicine;

(f) has failed to disclose a conviction in Hong Kong or elsewhere of an offence punishable with imprisonment to the Registrar in accordance with section 79(a); or

(g) has failed to disclose a record of misconduct in any professional respect to the Registrar in accordance with section 79(b),

the Practitioners Board may take any of the steps in subsection (3).

(3) The Practitioners Board may, in its discretion---

(a) order that the name of the registered Chinese medicine practitioner be removed from the Register;

(b) order that the name of the registered Chinese medicine practitioner be removed from the Register for such period as it may think fit and that the name be subsequently restored to the Register upon the expiry of such period;

(c) make any such order as in paragraph (a) or (b) but suspend its application, subject to such conditions as it thinks fit, for a period, or periods in aggregate, not exceeding 3 years;

(d) order that the registered Chinese medicine practitioner be reprimanded;

(e) make any such order as in paragraph (a) or (b) and further order that such order takes effect upon its publication in the Gazette if the Practitioners Board is satisfied that it is necessary for the protection of the public to do so; or

(f) order that a warning letter be served on the registered Chinese medicine practitioner.

(4) Where an order is made under subsection (3), the Practitioners Board may, in any case, make such order as it thinks fit with regard to the payment of costs of the Registrar, any complainant or any person presenting the case to the Practitioners Board and the registered Chinese medicine practitioner and any costs awarded may be recovered summarily as a civil debt in accordance with the provision of section 67 of the Magistrates Ordinance (Cap. 227).

(5) Except for an order made under subsection (3)(e), the Registrar shall not remove the name of the registered Chinese medicine practitioner from the Register---

(a) until after the expiry of the time within which an appeal may be lodged under section 103(1); or

(b) in the case of an appeal having in fact been lodged under section 103(1), until after a decision of the Court of Appeal has been made.

(6) Nothing in this section shall be deemed to require the Practitioners Board to inquire into the question as to whether a registered Chinese medicine practitioner was properly convicted when considering a record of conviction of the Chinese medicine practitioner under this section, but the Practitioners Board may consider any record of the case in which such conviction was recorded and any other evidence which may be available and is relevant as showing the nature and gravity of the offence.

(7) In deciding whether the Practitioners Board should be recommended to hold an inquiry under this section in respect of a case, the Disciplinary Committee of Chinese Medicine Practitioners shall act in accordance with the prescribed procedure for considering the case brought to its attention.

99. Meetings of Practitioners Board

for purpose of an inquiry

(1) The meetings of the Practitioners Board held for the purpose of conducting an inquiry under section 98 shall require a quorum of 5 members subject to at least one being a lay member.

(2) Only members who have attended all meetings held for the purpose of the inquiry may participate in the decision of the Practitioners Board.

(3) A member of the Disciplinary Committee of Chinese Medicine Practitioners who is also a member of the Practitioners Board shall not

attend a meeting of the Practitioners Board held for the purpose of inquiring into a case, if that member has taken part in its initial consideration when it was brought before the Disciplinary Committee of Chinese Medicine Practitioners.

100. Powers of Practitioners Board in regard

to obtaining of evidence and

conduct at proceedings

(1) For the purpose of conducting an inquiry under section 98, the Practitioners Board shall have the following powers---

(a) to hear, receive and examine evidence on oath;

(b) to summon any person to attend the inquiry to give evidence or produce any book, document or other thing in his possession and to examine him as a witness or require him to produce any book, document or other thing in his possession;

(c) to admit or exclude the public or any member of the public from the inquiry;

(d) to award any person summoned to attend the inquiry such

sum or sums as in the opinion of the Practitioners Board

may have been reasonably expended by him for attending the inquiry.

(2) Summonses to witnesses may be in such form as the Practitioners Board may determine and shall be signed by the chairman of the Practitioners Board.

(3) A summons to witness may be served personally, by post or by registered post.

(4) If it appears to the Practitioners Board that it is necessary to do so in the interests of the complainant, any witness concerned or the registered Chinese medicine practitioner who is the subject of an inquiry, it may order that all or any information relating to the inquiry may not be disclosed.

101. Appearance of counsel, etc.

The complainant in an inquiry under section 98 or the registered Chinese medicine practitioner whose conduct is the subject of such inquiry shall be entitled to be represented by a solicitor or counsel throughout the inquiry.

102. Service of orders made by

Practitioners Board

(1) A copy of any order made under section 98(3)(a), (b), (c) or (e) shall be served by the Registrar upon the registered Chinese medicine practitioner concerned.

(2) Where the Practitioners Board made an order under section 98(3)(d) or (f), the Registrar shall serve the reprimand or the warning letter together with the relevant order upon the registered Chinese medicine practitioner concerned.

103. Appeals against orders of

Practitioners Board

(1) Any person who is aggrieved by an order made in respect of him under section 56 or 98 may, within 1 month from the date of service of the order, appeal to the Court of Appeal.

(2) The Court of Appeal may affirm, reverse or vary the order appealed against.

(3) The decision of the Court of Appeal on any such appeal shall be final.

(4) The practice in relation to any such appeal shall be subject to any rules of court made under the High Court Ordinance (Cap. 4).

(5) The Court of Appeal shall not have power to hear any appeal against an order made under section 98 unless notice of such appeal was given within 1 month of the service of the order.

104. Publication of orders

(1) Where an order under section 98(3)(e) is made, the Practitioners Board shall, as soon as possible, publish the order in the Gazette.

(2) Where---

(a) an order under section 98(3)(a), (b), (c) or (d) is made;

(b) the time specified under section 103(1) within which an appeal against an order may be lodged has expired; and

(c) no such appeal has been lodged,

the Practitioners Board shall, within 1 month, publish the order in the Gazette.

(3) Where---

(a) an order under section 98(3)(f) is made;

(b) the time specified under section 103(1) within which an appeal against an order may be lodged has expired; and

(c) no such appeal has been lodged,

the Practitioners Board may, if it sees fit, within 1 month, publish the order in the Gazette.

(4) Where---

(a) an order under section 98(3)(a), (b), (c) or (d) is made; and

(b) an appeal has been lodged against the order within the time limit specified under section 103(1),

the Practitioners Board shall within 1 month after a decision affirming or varying the order has been made by the Court of Appeal, publish the order as affirmed or varied on appeal in the Gazette.

(5) Where---

(a) an order under section 98(3)(f) is made; and

(b) an appeal has been lodged against the order within the time limit specified under section 103(1),

the Practitioners Board may, as it sees fit, within 1 month after a decision affirming or varying the order has been made by the Court of Appeal, publish the order as affirmed or varied on appeal in the Gazette.

(6) Where an order is published in the Gazette under subsection (1), (2), (3), (4) or (5) the Practitioners Board---

(a) shall publish with such order sufficient particulars to acquaint the public with the nature of the matter to which the order relates; and

(b) may publish with such order an account of the proceedings of the inquiry at which the order was made.

PART XI

Offences

105. Penalty for failure to give evidence

(1) Subject to subsection (2), any person who being summoned to attend as a witness or to produce a book, document or any other thing at an inquiry under section 100(1)---

(a) refuses or neglects to do so; or

(b) refuses to answer any question put to him---

(i) by the Practitioners Board; or

(ii) with the concurrence of the Practitioners Board,

commits an offence and is liable to a fine at level 3 and to imprisonment for 6 months.

(2) Notwithstanding subsection (1), no person shall be bound to incriminate himself and every witness shall, in respect of any evidence given by him before the Practitioners Board, be entitled to the privileges to which he would be entitled if giving evidence before a court of justice.

106. Penalty for not complying with an order

regarding non-disclosure of information

A person who does not comply with an order under section 100(4) commits an offence and is liable to a fine at level 3 and to imprisonment for 6 months.

107. Fraudulent registration, etc.

Any person who fraudulently procures or attempts to procure himself or any other person to be registered as a registered Chinese medicine practitioner or to be listed as a listed Chinese medicine practitioner, by making or producing, or causing to be made or produced, any false or fraudulent representations or declaration, either oral or in writing, commits an offence and is liable on conviction upon indictment to imprisonment for 3 years.

108. Unlawful use of title, etc. and practise

without registration

(1) Any person who---

(a) wilfully or falsely pretends---

(i) to be qualified to practise Chinese medicine; or

(ii) to be a listed Chinese medicine practitioner; or

(iii) to be a registered Chinese medicine practitioner; or

(iv) that his name is included in the Register; or

(b) falsely takes or uses any name, title, addition or description implying that---

(i) he is qualified to practise Chinese medicine; or

(ii) he is a listed Chinese medicine practitioner; or

(iii) he is a registered Chinese medicine practitioner; or

(iv) his name is included in the Register; or

(c) not being a registered Chinese medicine practitioner or listed Chinese medicine practitioner, professes to practise or publishes his name as practising Chinese medicine, commits an offence and is liable to a fine at level 6 and to imprisonment for 3 years.

(2) Subject to subsection (3), any person who not being a registered Chinese medicine practitioner or listed Chinese medicine practitioner---

(a) practises Chinese medicine commits an offence and is liable---

(i) to a fine at level 6 and to imprisonment for 3 years; or

(ii) on conviction upon indictment to imprisonment for 5 years; or

(b) practises Chinese medicine in relation to a person which results in personal injury to that person commits an offence and is liable---

(i) to a fine of $200,000 and to imprisonment for 3 years; or

(ii) on conviction upon indictment to imprisonment for 7 years.

(3) Subsection (2) shall not apply to the dispensing of Chinese herbal medicines by a dispenser or person nominated under section 114(2)(b)(i) or (ii) at the premises in respect of which a retailer licence is in force.

(4) Any person with limited registration who---

(a) wilfully or falsely pretends to be qualified to practise Chinese medicine; or

(b) wilfully or falsely takes or uses any name, title, addition or description implying that he is qualified to practise Chinese medicine,

beyond the limits defined in the direction under sections 85 and 86 relating to that registration commits an offence and is liable to a fine at level 3 and to imprisonment for 6 months.

(5) For the purposes of this section---

(a) the suggestion of a well-established prescription of Chinese herbal medicines to a single individual without carrying out any diagnosis on the basis of traditional Chinese medicine by a dispenser or person nominated under section 114(2)(b)(i) or (ii) at the premises in respect of which a retailer licence is in force shall not be regarded as practising Chinese medicine for the purpose of subsection (2);

(b) a person who fraudulently procures himself to be registered as a registered Chinese medicine practitioner or listed as a listed Chinese medicine practitioner, by making or producing, or causing to be made or produced, any false or fraudulent representations or declaration, either oral or in writing, shall be deemed not to have been so registered or so listed, as the case may be.

PART XII

Licensing of Chinese Herbal Medicines Traders

109. Restriction on sale, etc. of

Schedule 1 medicines

(1) Except under and in accordance with this Ordinance, no person shall---

(a) sell by retail; or

(b) dispense to another person,

any Chinese herbal medicine specified in Schedule 1---

(i) except in accordance with a prescription given by a registered Chinese medicine practitioner; or

(ii) without a retailer licence in respect of such Chinese herbal medicine; or

(iii) subject to section 145(1), at any place other than the premises specified in such licence.

(2) Except under and in accordance with this Ordinance, no person shall---

(a) sell or distribute by way of wholesale; or

(b) possess for the purpose of wholesale,

any Chinese herbal medicine specified in Schedule 1---

(i) without a wholesaler licence in Chinese herbal medicines in respect of such Chinese herbal medicine; or

(ii) subject to section 145(1), at any place other than the premises specified in such licence.

110. Possession of Schedule 1 medicines

Except under and in accordance with this Ordinance, no person shall have in his possession any Chinese herbal medicine specified in Schedule 1, unless the Chinese herbal medicine is possessed under and in accordance with a licence granted by the Medicines Board under this Ordinance.

111. Restriction on sale, etc. of

Schedule 2 medicines

(1) Except under and in accordance with this Ordinance, no person shall---

(a) sell by retail; or

(b) dispense to another person; or

(c) possess for the purpose of retail,

any Chinese herbal medicine specified in Schedule 2---

(i) without a retailer licence in respect of such Chinese herbal medicine; or

(ii) subject to section 145(1), at any place other than the premises specified in such licence.

(2) Except under and in accordance with this Ordinance, no person shall--- (a) sell or distribute by way of wholesale; or

(b) possess for the purpose of wholesale,

any Chinese herbal medicine specified in Schedule 2---

(i) without a wholesaler licence in Chinese herbal medicines in respect of such Chinese herbal medicine; or

(ii) subject to section 145(1), at any place other than the premises specified in such licence.

112. Application of Schedules 1 and 2

The Chinese herbal medicines specified in Schedules 1 and 2 shall apply to the dried or processed form of such medicines unless otherwise specified.

113. Amendment of Schedules 1 and 2

The Secretary may, after the consultation with the Council, by order published in the Gazette, amend Schedules 1 and 2.

114. Licensing of retailers in Chinese

herbal medicines

(1) Any person may apply to the Medicines Board for a retailer licence.

(2) An application under subsection (1) shall---

(a) be in such form and accompanied by such documents, information and particulars as the Medicines Board may determine;

(b) include the following nominations---

(i) a person who will be responsible for the supervision of the dispensing of Chinese herbal medicines; and

(ii) a deputy to act in the absence of that person;

(c) specify the Chinese herbal medicines to which the application relates; and

(d) specify the location of the premises to which the application relates.

(3) If the Medicines Board is satisfied that an application under subsection (1) complies with the prescribed licensing requirements, it may, upon payment of a prescribed fee, issue a retailer licence subject to such restrictions or conditions as may be imposed.

(4) If, having regard to the provisions of the Ordinance, the Medicines Board considers it necessary in the public interest to do so, it may refuse an application under subsection (1) and thereupon notify the applicant in writing of the reasons for refusal.

115. Licensing of wholesale dealers in

Chinese herbal medicines

(1) Any person may apply to the Medicines Board for a wholesaler licence in Chinese herbal medicines.

(2) An application under subsection (1) shall---

(a) be in such form and accompanied by such documents, information and particulars as the Medicines Board may determine;

(b) specify the Chinese herbal medicines to which the application relates; and

(c) specify the location of the premises to which the application relates.

(3) If the Medicines Board is satisfied that an application under subsection (1) complies with the prescribed licensing requirements, it may, upon payment of a prescribed fee, issue a wholesaler licence in Chinese

herbal medicines subject to such restrictions or conditions as may be imposed.

(4) If, having regard to the provisions of the Ordinance, the Medicines Board considers it necessary in the public interest to do so, it may refuse an application under subsection (1) and thereupon notify the applicant in writing of the reasons for refusal.

116. Duration and renewal of licences

(1) Subject to section 139, a licence issued under section 114 or 115 shall be for such period as may be prescribed.

(2) A licence holder may apply to the Medicines Board for the renewal of the licence.

(3) On an application for renewal under this section, the Medicines Board may---

(a) upon payment of a prescribed fee, renew the licence, with or without modifications to the conditions or restrictions, if any, previously imposed and for such period as may be prescribed or for such shorter period as it considers appropriate; or

(b) refuse the application, if, having regard to the provisions of the Ordinance, it considers it necessary in the public interest to do so.

(4) Where the Medicines Board refuses an application for renewal under this section, it shall notify the applicant in writing of the reasons for refusal.

117. Certified copy of licences

The Medicines Board may, upon application and payment of a prescribed fee by the holder of a licence issued under this Part, issue a certified copy of that licence to the licence holder.

118. Provision for transitional licensing of

Chinese herbal medicines traders

(1) A person who---

(a) carries on a business in the retail or wholesale of Chinese herbal medicines on 3 January 2000; and

(b) makes an application to the Medicines Board within such

period of time as may be determined by the Medicines Board for a retailer licence or wholesaler licence in Chinese herbal medicines, as the case may be, in accordance with section 114 or 115, shall be deemed, under this subsection, to have been granted a licence

issued under section 114 or 115 as appropriate, subject to such terms and conditions as may be imposed by the Medicines Board by notice in writing to that person, and the licence shall, subject to section 139, continue in effect until---

(i) the issue of a licence under section 114(3) or 115(3), as the case may be;

(ii) the refusal of his application for a licence under section 114(4) or 115(4), as the case may be; or

(iii) such date as may be specified and promulgated by the Secretary by notice published in the Gazette,

whichever is the earliest.

(2) Confirmation in writing by the Medicines Board of the receipt of an application shall be sufficient evidence of a licence deemed to be granted under subsection (1).

(3) Where a person would, but for this subsection, be liable to be prosecuted for a contravention of section 109, 110 or 111 for trading in or possessing any Chinese herbal medicine specified in Schedule 1 or 2 without a licence, then that person shall not be so liable until after the expiry of the period of time referred to in subsection (1)(b) notwithstanding that on the expiry of such period of time, no application has been made to the Medicines Board.

PART XIII

Registration of Proprietary Chinese Medicines

119. Proprietary Chinese medicines

to be registered

(1) Except under and in accordance with this Ordinance and subject to subsection (2), no person shall---

(a) sell; or

(b) import; or

(c) possess,

any proprietary Chinese medicine unless the proprietary Chinese medicine is registered under section 121.

(2) Subsection (1) shall not apply to any substance or product which is registered under the Pharmacy and Poisons Ordinance (Cap. 138).

(3) Nothing in subsection (1) shall operate so as to prohibit a manufacturer from manufacturing or a wholesaler of proprietary Chinese medicine from importing a proprietary Chinese medicine of a reasonable quantity for the purposes of providing samples and seeking registration under section 121.

(4) For the purpose of subsection (1), a proprietary Chinese medicine shall not be taken as registered under section 121 unless its particulars are identical with the registered particulars of the registered proprietary Chinese medicine.

120. Application for registration of proprietary

Chinese medicines to be made by

manufacturers, importers, etc.

An application for the registration of a proprietary Chinese medicine shall be made---

(a) in the case of its being manufactured in Hong Kong, by the manufacturer;

(b) in the case of its being manufactured outside Hong Kong,---

(i) by the importer; or

(ii) by the local representative or agent of the manufacturer, prior to its being imported into Hong Kong.

121. Registration of proprietary

Chinese medicines

(1) An application for the registration of a proprietary Chinese medicine shall be made to the Medicines Board and shall---

(a) be in such form and accompanied by such documents, information, samples and other materials as the Medicines Board may determine;

(b) furnish the particulars of the proprietary Chinese medicine required to be registered in accordance with the prescribed requirements; and

(c) be accompanied by a prescribed application fee.

(2) Subject to section 122, the Medicines Board may approve the application and upon payment of a prescribed issue fee, register the proprietary Chinese medicine and issue a certificate of registration to the applicant in respect of the proprietary Chinese medicine in such form as it may determine.

(3) Subject to the certificate of registration being issued, the Medicines Board may impose such conditions as it thinks fit and may amend, vary or revoke the conditions if it appears to the Medicines Board that the conditions should be amended, varied or revoked.

(4) If, having regard to the provisions of the Ordinance, the Medicines Board considers it necessary in the public interest to do so, it may refuse an application for registration made under subsection (1) and thereupon notify the applicant in writing of the reasons for refusal.

122. Factors relevant to determination of

application for registration

(1) In determining an application for registration of a proprietary Chinese medicine, the Medicines Board shall in particular take into consideration---

(a) the safety of the proprietary Chinese medicine to which the application relates;

(b) the quality of the proprietary Chinese medicine according to the specification and the method or proposed method of manufacture of the medicine, and the provisions proposed for securing that medicine as sold or supplied will be of that quality; and

(c) the efficacy of the proprietary Chinese medicine for the purposes for which the medicine is proposed to be administered.

(2) In taking into consideration the efficacy for a particular purpose of a proprietary Chinese medicine to which an application relates, the Medicines Board shall disregard any question whether a proprietary Chinese medicine of another description would or might be equally or more efficacious for that purpose.

(3) For the purpose of subsection (1), nothing in subsection (2) shall be construed as requiring the Medicines Board, in considering the safety of a proprietary Chinese medicine of a particular description, in relation to a purpose for which it is proposed to be administered, to disregard any question whether a proprietary Chinese medicine of another description, being equally or more efficacious for that purpose, would or might be safer in relation to that purpose.

(4) In determining an application relating to a proprietary Chinese medicine which is to be imported, the Medicines Board---

(a) shall also take into consideration in particular the methods, standards and conditions of manufacture of the medicine; and

(b) may, if it thinks fit, require the production by the applicant of any one or a combination of the following---

(i) an undertaking, given by the manufacturer of the proprietary Chinese medicine, to permit the premises

where it is or is to be manufactured, and the operations carried on or to be carried on in the course of manufacturing it, to be inspected by or on behalf of the Medicines Board;

(ii) an undertaking, given by the manufacturer of the proprietary Chinese medicine, to comply with any conditions as imposed by the Medicines Board;

(iii) a declaration, given by or on behalf of the manufacturer of the proprietary Chinese medicine that, in relation to the manufacture of the proprietary Chinese medicine any requirements imposed by or under the law of the place in which it is or is to be manufactured have been or will be complied with.

123. Duration and renewal of registration

(1) The registration of a proprietary Chinese medicine under section 121 shall have effect for such period as may be prescribed.

(2) The holder of a certificate of registration may apply to the Medicines Board for the renewal of registration.

(3) On an application for renewal under this section, the Medicines Board may---

(a) upon payment of a prescribed fee, renew the registration and issue a certificate of registration, with or without modifications to the conditions, if any, previously imposed for such period as may be prescribed or for such shorter period as it considers appropriate; or

(b) refuse the application, if, having regard to the provisions of the Ordinance, it considers it necessary in the public interest to do so.

(4) Where the Medicines Board refuses an application for renewal under this section, it shall notify the applicant in writing of the reasons for refusal.

124. Variation of registered particulars of registered proprietary Chinese medicines

(1) The holder of a certificate of registration may, on payment of a prescribed fee, apply in writing to the Medicines Board for approval to vary the registered particulars of the proprietary Chinese medicine to which the certificate relates except the following particulars---

(a) the product name;

(b) the dose form; and

(c) the name and quantity of any active ingredient.

(2) If the Medicines Board is satisfied that the proposed variation will not adversely affect the safety, quality and efficacy of the relevant proprietary Chinese medicine, it may approve the variation as proposed in the application.

(3) The Medicines Board shall advise the applicant in writing---

(a) whether the application for variation is approved; and

(b) if it is approved, the date on which the variation takes effect; or

(c) if it is disapproved, the reason for disapproval.

(4) Where the variation of the registered particulars of a proprietary Chinese medicine registered under section 121 takes effect, the proprietary Chinese medicine to which the registered particulars were related before the variation shall cease to be a proprietary Chinese medicine registered under that section.

(5) Where by virtue of subsection (4) a proprietary Chinese medicine ceases to be a proprietary Chinese medicine registered under section 121, the relevant applicant shall before the relevant variation takes effect, recall or cause to recall, to the extent reasonably possible, the proprietary Chinese medicine already supplied.

125. De-registration of proprietary

Chinese medicines

(1) The Medicines Board may de-register a proprietary Chinese medicine if it considers it necessary in the public interest to do so.

(2) Where the Medicines Board intends to de-register a proprietary Chinese medicine, it shall notify the holder of the certificate of registration in writing of its intention and invite him to submit any representations,

information or explanation in writing.

(3) Notwithstanding subsection (2), the Medicines Board may de-register a proprietary Chinese medicine forthwith if it considers that an emergency exists.

(4) Where the Medicines Board determines to de-register a proprietary Chinese medicine, it shall forward to the holder of the certificate of registration a notice of de-registration and shall state in such notice its reasons for de-registration.

(5) The Medicines Board may publish in the Gazette a list of all proprietary Chinese medicines de-registered under subsections (1) and (3) when it considers appropriate.

126. Publication of registered proprietary

Chinese medicines

The Medicines Board may publish in the Gazette from time to time as it considers appropriate a list of registered proprietary Chinese medicines.

127. Certified copy of certificate

of registration

The Medicines Board may, upon application and payment of a prescribed fee by the holder of a certificate of registration issued under this Part, issue a certified copy of that certificate of registration to the certificate holder.

128. Provision for transitional registration

of proprietary Chinese medicines

(1) Where a proprietary Chinese medicine is, on 1 March 1999---

(a) manufactured, sold or supplied for sale in Hong Kong; or

(b) manufactured outside Hong Kong and is sold or supplied for sale in Hong Kong, a person who is, on the same date---

(i) in the case of paragraph (a), the manufacturer; or

(ii) in the case of paragraph (b), an importer, or a local representative or agent of the manufacturer,

may apply to the Medicines Board within such period of time as may be determined by the Medicines Board for the registration of the proprietary Chinese medicine in accordance with section 121.

(2) Where an application is made under subsection (1), the proprietary Chinese medicine shall be deemed, under this subsection, to have been registered and a certificate is deemed to have been issued under section 121 subject to such classification of category, conditions and restrictions as may be imposed by the Medicines Board by notice in writing to the applicant.

(3) Subject to subsection (7), such registration shall continue in effect until---

(a) the issue of a certificate of registration under section 121(2); or

(b) the refusal of the application for registration of that proprietary Chinese medicine under section 121(4); or

(c) such date as may be specified and promulgated by the Secretary by notice published in the Gazette,

whichever is the earliest.

(4) Confirmation in writing by the Medicines Board of the receipt of an application shall be sufficient evidence of a certificate deemed to be issued under subsection (2).

(5) The Medicines Board may amend, vary or revoke any of the classification of category, conditions or restrictions imposed under subsection (2).

(6) Where a person would, but for this subsection, be liable to be prosecuted for a contravention of section 119 for trading in, importing or possessing a proprietary Chinese medicine which, but for this subsection, would otherwise be required to be registered, then the person shall not be so liable until after the expiry of the period of time referred to in subsection (1) notwithstanding that on the expiry of such period of time, no application has been made to the Medicines Board.

(7) Section 125 and any requirements in respect of proprietary Chinese medicines imposed by regulations made under section 160 shall apply to proprietary Chinese medicines deemed to be registered under this section.

129. Clinical trials and medicinal tests

(1) For the purpose of facilitating the conduct of a clinical trial or medicinal test of any proprietary Chinese medicine, the Medicines Board may, upon application, issue a certificate for clinical trial and medicinal test.

(2) An application shall be in such form and accompanied by such documents, information, samples and other materials as the Medicines Board may determine and a prescribed application fee.

(3) The Medicines Board may, on payment of a prescribed issue fee, issue a certificate for clinical trial and medicinal test, and such certificate shall be valid for such period and subject to such conditions as the Medicines Board thinks fit.

(4) If, having regard to the provisions of this Ordinance, the Medicines Board considers it necessary in the public interest to do so, it may refuse an application made under subsection (1).

130. Certificate of sale of proprietary

Chinese medicines

(1) For the purpose of exporting a proprietary Chinese medicine which is registered under section 121 and manufactured by a manufacturer licensed under section 132, the Medicines Board may, upon application, issue in the prescribed form a certificate certifying that the proprietary Chinese medicine is allowed to be sold in Hong Kong and containing such statements relating to the proprietary Chinese medicine as it considers appropriate.

(2) The certificate referred to in subsection (1) is issued subject to the payment of a prescribed fee.

PART XIV

Licensing of Proprietary Chinese Medicines Traders

131. Restriction on manufacture of proprietary

Chinese medicines

Except under and in accordance with this Ordinance, no person shall manufacture any proprietary Chinese medicine, whether registered or not---

(a) without a manufacturer licence; or

(b) subject to section 145(1), at any place other than the premises specified in such licence.

132. Licensing of manufacturers

(1) An application for a licence to manufacture proprietary Chinese medicines shall be made to the Medicines Board and shall---

(a) be in such form and accompanied by such documents, particulars and other materials as the Medicines Board may determine;

(b) include the following nominations---

(i) a person who will be responsible for the supervision of the manufacture of proprietary Chinese medicines; and

(ii) a deputy to act in the absence of that person; and

(c) specify the location of the premises to which the application relates.

(2) If the Medicines Board is satisfied that an application made under subsection (1) complies with the prescribed licensing requirements, it may, upon payment of a prescribed fee, issue a manufacturer licence in a prescribed form subject to such conditions or restrictions as may be prescribed.

(3) Without prejudice to the generality of subsection (2), the Medicines Board may impose a condition prohibiting the manufacturing of certain proprietary Chinese medicines if the Medicines Board considers it necessary in the public interest to do so.

(4) If, having regard to the provisions of the Ordinance, the Medicines Board considers it necessary in the public interest to do so, it may refuse an application made under subsection (1) and thereupon notify the applicant in writing of the reasons for refusal.

133. Certificate for manufacturer

The Medicines Board may, upon application and payment of a prescribed fee, issue a certificate in a prescribed form, to be known as a certificate for manufacturer, certifying that the holder of a manufacturer licence follows the requirements of good practices in manufacture and quality control of proprietary Chinese medicines.

134. Restriction on sale, etc. of proprietary

Chinese medicines

Except under and in accordance with this Ordinance, no person shall---

(a) sell or distribute by way of wholesale; or

(b) possess for the purpose of wholesale,

any proprietary Chinese medicine---

(i) without a wholesaler licence in proprietary Chinese medicines; or

(ii) subject to section 145(1), at any place other than the premises specified in such licence.

135. Licensing of wholesale dealers in

proprietary Chinese medicines

(1) An application for a wholesaler licence in proprietary Chinese medicines shall be made to the Medicines Board and shall---

(a) be in such form and accompanied by such documents, particulars and other materials as the Medicines Board may determine; and

(b) specify the location of the premises to which the application relates.

(2) If the Medicines Board is satisfied that an application made under subsection (1) complies with the prescribed licensing requirements, it may, upon payment of a prescribed fee, issue a wholesaler licence in proprietary Chinese medicines subject to such restrictions or conditions as it may impose.

(3) If, having regard to the provisions of this Ordinance, the Medicines Board considers it necessary in the public interest to do so, it may refuse an application made under subsection (1) and thereupon notify the applicant in writing of the reasons for refusal.

136. Duration and renewal of licences

(1) Subject to section 139, a licence issued under section 132 or 135 shall be for such period as may be prescribed.

(2) A licence holder may apply to the Medicines Board for the renewal of the licence.

(3) On an application for renewal under this section, the Medicines Board may---

(a) upon payment of a prescribed fee, renew the licence, with or without modifications to the conditions or restrictions, if any, previously imposed and for such period as may be prescribed or for such shorter period as it considers appropriate; or

(b) refuse the application, if, having regard to the provisions of the Ordinance, it considers it necessary in the public interest to do so.

(4) Where the Medicines Board refuses an application for renewal under this section, it shall notify the applicant in writing of the reasons for refusal.

137. Certified copy of licences, etc.

The Medicines Board may, upon application and payment of a prescribed fee by the holder of a licence or certificate issued under this Part, issue a certified copy of that licence or certificate to the relevant holder.

138. Provision for transitional licensing of proprietary Chinese medicines traders

(1) A person who---

(a) carries on a business in the manufacture or wholesale of proprietary Chinese medicines on 3 January 2000; and

(b) makes an application to the Medicines Board within such period of time as may be determined by the Medicines Board for a manufacturer or wholesaler licence in proprietary Chinese medicines, as the case may be, in accordance with section 132 or 135,

shall be deemed to have been granted a licence under section 132 or 135 as appropriate, subject to such terms and conditions as may be imposed by the Medicines Board by notice in writing to the applicant, and the licence shall, subject to section 139, continue in effect until---

(i) the issue of a licence under section 132(2) or 135(2), as the case may be;

(ii) the refusal of the application for a licence under section 132(4) or 135(3), as the case may be; or

(iii) such date as may be specified or promulgated by the Secretary by notice published in the Gazette,

whichever is the earliest.

(2) Confirmation in writing by the Medicines Board of the receipt of an application shall be sufficient evidence of a licence deemed to be granted under subsection (1).

(3) Where a person would, but for this subsection, be liable to be prosecuted for a contravention of section 131 or 134 for manufacturing, trading in or possessing any proprietary Chinese medicine without a licence, then the person shall not be so liable until after the expiry of the period of time referred to in subsection (1)(b) notwithstanding that on the expiry of such period of time, no application has been made to the Medicines Board.

PART XV

Review, Appeal, Proceedings and Offences, etc.

139. Powers to suspend, revoke, etc. licences

(1) This section applies to licences---

(a) issued under sections 114, 115, 132 and 135;

(b) renewed under sections 116 and 136; and

(c) deemed to be granted under sections 118 and 138.

(2) The Medicines Board may---

(a) suspend a licence for such period as it may determine;

(b) revoke a licence;

(c) vary the conditions or restrictions subject to which a licence was issued; or

(d) issue a warning to the licence holder,

if---

(i) having regard to the provisions of this Ordinance and on the recommendation of the Regulatory Committee of Chinese Medicines Traders, the Medicines Board considers it necessary in the public interest to do so; or

(ii) the Medicines Board is satisfied, on the recommendation of the Regulatory Committee of Chinese Medicines Traders, that the licence holder---

(A) has failed to comply with the conditions or restrictions subject to which the licence was issued;

(B) has failed to comply with any prescribed conditions or duties in respect of the practice of his trade; or

(C) has been convicted of an offence under this Ordinance.

(3) The suspension or revocation of a licence may be limited to---

(a) proprietary Chinese medicines of one or more descriptions;

(b) Chinese herbal medicines of one or more descriptions;

(c) proprietary Chinese medicines manufactured or stored in any particular premises or in a particular part of any premises; or

(d) Chinese herbal medicines stored in any particular premises or in a particular part of any premises.

(4) For the purposes of exercising its powers under this section in a particular case---

(a) the meetings of the Medicines Board shall require a quorum of 5 members subject to at least one being a lay member;

(b) only members who have attended all meetings held for the purpose of that particular case may participate in the decision of the Medicines Board;

(c) the Medicines Board may invite the licence holder concerned to give representations orally or otherwise before it makes a decision.

(5) A member of the Regulatory Committee of Chinese Medicines Traders who is also a member of the Medicines Board shall not attend a meeting of the Medicines Board held for the purpose of exercising its power under this section, if that member---

(a) has taken part in the consideration of the case when it was brought before the Regulatory Committee of Chinese Medicines Traders; or

(b) is the licence holder whose licence is in question.

(6) The Regulatory Committee of Chinese Medicines Traders shall act in accordance with the regulations made under section 160.

(7) The Medicines Board shall notify the licence holder concerned in writing of its decision made under this section and the reasons for the decision.

140. Review of decisions

(1) Where powers under section 114, 115, 116, 121, 123, 124, 125, 129, 132, 135 or 136 exercisable by the Medicines Board have been delegated to the Chinese Medicines Committee or the Chinese Medicines Traders Committee, as the case may be, any person aggrieved by its decision may request the Medicines Board to review the decision.

(2) A request for review under subsection (1) shall state the reasons relied upon and shall be made to the Medicines Board within 14 days after the receipt of the notification of decision.

(3) Upon receipt of the written request for review, the Medicines Board shall review the decision and shall serve a notice of its decision together with the reasons for its decision on the person concerned.

(4) In reviewing a decision, the Medicines Board may invite the person concerned to give representations in writing or in person.

141. Right of appeal to Court of

First Instance

(1) A person aggrieved by any decision of the Medicines Board made under section 114, 115, 116, 121, 123, 124, 125, 129, 132, 135, 136, 139 or 140 may appeal to the Court of First Instance within 1 month from the date of service of the notice.

(2) The Court of First Instance may affirm, reverse or vary the decision appealed against.

(3) The decision of the Court of First Instance shall be final.

142. Chinese herbal medicines

to be labelled

A wholesale dealer in Chinese herbal medicines shall attach to or print on any container of Chinese herbal medicine a label or cause a label to be so attached or printed in the prescribed manner.

143. Proprietary Chinese medicines

to be labelled

No person shall---

(a) sell; or

(b) have in his possession for the purpose of selling,

any proprietary Chinese medicine unless the package of the proprietary Chinese medicine is labelled in the prescribed manner.

144. Package inserts for proprietary

Chinese medicines

No person shall---

(a) sell; or

(b) have in his possession for the purpose of selling,

any proprietary Chinese medicine without a package insert which complies with the prescribed requirements.

145. Change of address of premises, etc.

(1) Where there is a change in the address of the premises specified in a licence issued under this Ordinance, the licence shall become void at the expiry of 1 month from the date on which such change occurs unless---

(a) an application for change of the address specified in the licence has been made by the licence holder to the Medicines Board;

(b) a prescribed fee has been paid; and

(c) the Medicines Board has approved such change.

(2) A licence holder shall notify the Medicines Board in writing of any change in the person or his deputy nominated in writing under section 114(2)(b) or 132(1)(b), as the case may be, within 1 month from the date of such change.

146. Inspection and enforcement of Ordinance

(1) The Director may authorize in writing any public officer to be an inspector for the purpose of enforcing any provisions under this Ordinance and its regulations made under section 160.

(2) Subject to section 147, an inspector authorized under this section shall, for the purpose of enforcing the provisions under this Ordinance and its regulations, have powers---

(a) at all reasonable times to enter and inspect any premises specified in the licence of a Chinese medicines trader where---

(i) the wholesale or retail of any Chinese herbal medicines; or

(ii) the wholesale or manufacturing of any proprietary Chinese medicines, is carried on;

(b) upon the production of his authority as an inspector, at any time to enter and search any place and to stop, board and search any vessel, vehicle, train or aircraft (other than a ship of war, military aircraft or military vehicle) in which he has reason to suspect that an offence under this Ordinance is being or has been committed;

(c) in any premises or place entered pursuant to paragraph (a) or (b), to seize, remove and detain any article, document or thing which appears to him to be or to contain evidence of an offence against this Ordinance; (d) to make such examination and inquiry and to do such other things, including the taking, on payment therefor, of samples as may be necessary for the purposes of the inspection;

(e) to seize, remove and detain any Chinese herbal medicines specified in Schedule 1 or 2 which he has reasonable cause to suspect is in the possession of any person in contravention of section 110 or 111;

(f) to seize, remove and detain any proprietary Chinese medicines which he has reasonable cause to suspect is in the possession of any person in contravention of section 119, 134, 143 or 144.

(3) Any person who wilfully delays or obstructs an inspector in the exercise of any powers under this section, or refuses without reasonable excuse to allow any sample to be taken in accordance with this section, or fails without reasonable excuse to give any information which he is duly required under this section to give commits an offence.

(4) If, without reasonable excuse, any person appearing to an inspector to be in charge of premises where a business of---

(a) the wholesale or retail of any Chinese herbal medicine; or

(b) the wholesale or manufacture of any proprietary Chinese medicine, is conducted, fails to disclose particulars to identify the licence holder or the owner of the business upon being required to do so by the inspector, commits an offence.

(5) Nothing in this section shall authorize an inspector to enter or inspect the premises of a registered Chinese medicine practitioner, a listed Chinese medicine practitioner or a person who continues to practise Chinese medicine by virtue of section 90(7), other than those premises where the dispensing or compounding of Chinese herbal medicines or proprietary Chinese medicines is carried on.

147. Power of entry and search in relation

to domestic premises

(1) No domestic premises shall be entered or searched by an inspector unless---

(a) a magistrate has issued a warrant under subsection (2) or

(b) the Director has given an authorization under subsection (3).

(2) A magistrate may, if he is satisfied by information on oath that there is reasonable ground for suspecting that there are in any domestic premises any article, document or thing which may be seized, removed or detained under section 146(2)(c), (d), (e) and (f), issue a warrant authorizing an inspector to enter and search the premises.

(3) The Director may, if he is satisfied that there is reasonable ground for suspecting---

(a) that there is in any domestic premises any article, document or thing which may be seized, removed or detained under section 146(2)(c), (d), (e) and (f); and

(b) that unless the premises are entered and searched immediately such article, document or thing is likely to be removed from the premises, authorize in writing an inspector to enter and search the premises.

(4) An inspector authorized under subsection (2) or (3) to enter and search domestic premises may take with him any other person and any equipment as may appear to him to be necessary to assist him in entering and searching the premises.

148. Protection of informers

(1) No information laid in respect of any offence under this Ordinance shall be admitted in evidence and no witness in any proceedings for an offence under this Ordinance shall be obliged or permitted to disclose the name or address of any informer or state any matter which might lead to the discovery of the informer.

(2) If any books, documents or papers which are in evidence or liable to inspection in any such proceedings contain any entry in which any informer is named or described or which might lead to his discovery, the court may cause all such passages to be concealed from view or to be obliterated so far as may be necessary to protect the informer from discovery.

(3) Where after full inquiry into the case---

(a) the court is satisfied that the informer wilfully made in his information a material statement which he knew or believed to be false, or did not believe to be true; or

(b) it appears to the court that justice cannot otherwise fully be done, the court may require the production of the original information and permit inquiry and require full disclosure concerning the informer.

149. Protection of public officers

A public officer is not personally liable for any act or omission of his if it was done or made by him in the honest belief that it was required or authorized in the exercise of any function under this Ordinance.

150. Liability for acts of servants

(1) Where an offence against this Ordinance is committed by a servant of a holder of a licence issued under this Ordinance, the holder of the licence shall, without prejudice to the liability of any other person, also be guilty of that offence but shall not be liable to any term of imprisonment.

(2) Where a prosecution is brought against a holder of a licence by virtue of this section in respect of an offence under section 154(1) committed by a servant, it shall be a defence if the holder of the licence shows that he exercised such control over the servant as would ensure that the servant was not likely to act in contravention of the provision in question.

151. Commencement of proceedings

Notwithstanding any provision in any Ordinance prescribing the period within which summary proceedings may be commenced, proceedings for an offence under this Ordinance may be commenced at any time within the period of 12 months after the date of commission of the offence.

152. Forfeiture

(1) Any magistrate may, on application by the Government, order to be forfeited any Chinese herbal medicines or proprietary Chinese medicines, or any article or substance with respect to which any offence relating to Chinese herbal medicines or proprietary Chinese medicines under this Ordinance has been committed, whether or not any person has been convicted of such offence, and upon the making of any order of forfeiture, such medicines, article or substance shall be deemed to be the property of the Government free from all rights of any person.

(2) In any proceedings on application under this section, any statement or other indication of the nature of any substance or article written upon or attached to any substance, article or container shall, until the contrary is proved, be deemed to be a true description of the substance or article or of the contents of the container, as the case may be.

153. Provision of information

(1) For the purposes of determining an application for a licence, certificate or renewal of the same under this Ordinance, the Medicines Board may serve on the applicant a notice requiring him to furnish to it such information relating to the application and within such time as may be specified in the notice.

(2) Where the applicant fails to furnish the information, the Medicines Board may decline to process the application further or reject the application.

(3) No person who, in making an application to the Medicines Board or in giving any information which he is required to give under this section, shall make a statement or representations which he knows to be false or does not believe to be true in a material particular.

154. Offences and penalty

(1) Any person who contravenes section 109, 110, 111, 119(1), 131, 134, 142, 143, 144, 146(3) or (4) or 153(3) commits an offence.

(2) Any person who is found guilty of an offence under this Ordinance shall, unless a penalty is otherwise expressly provided, be liable to a fine at level 6 and to imprisonment for 2 years.

155. Defence

(1) In any proceedings for a contravention of section 110, it shall be a defence for a person charged to prove that he---

(a) did not know;

(b) had no reason to suspect; and

(c) could not with reasonable diligence have discovered,

that the Chinese herbal medicine was not supplied to him in accordance with this Ordinance.

(2) In any proceedings for a contravention of section 119(1), it shall be a defence for a person charged to prove that he---

(a) did not know;

(b) had no reason to suspect; and

(c) could not with reasonable diligence have discovered,

that the proprietary Chinese medicine was not registered under section 121.

PART XVI

Delegations, Exemptions and Regulations, etc.

156. Delegations

(1) The boards or committees set out in column 1 of Schedule 5 may delegate all or any of their respective functions to the boards or committees set forth opposite them in columns 2 and 3 of that Schedule respectively.

(2) The Secretary may, after consultation with the Council, by order published in the Gazette, amend Schedule 5.

157. Exemptions

(1) The Medicines Board may exempt, with or without conditions or restrictions, a person or institution concerned with education or scientific research from the application of sections 109(2), 110, 111(2), 119, 131 and 134 if the Chinese herbal medicines or proprietary Chinese medicines in question are required for the purposes of education or scientific research.

(2) Nothing in sections 109(1), 110 and 111(1) shall apply to a registered Chinese medicine practitioner if, and only if, the Chinese herbal medicines in question are---

(a) being used for the purpose of administering to a patient under his direct care; and

(b) dispensed on a prescription given by him and at the premises where he practises.

(3) Nothing in section 110 shall apply to a person in bona fide possession of any Chinese herbal medicine specified in Schedule 1 if and only if such medicine has been supplied to him---

(a) by a person who is the holder of a licence issued under this Ordinance to trade in such Chinese herbal medicine;

(b) in accordance with a prescription given by a registered Chinese medicine practitioner; or

(c) in accordance with this Ordinance.

(4) Nothing in section 111(1) shall apply to a listed Chinese medicine practitioner or a person who continues to practise Chinese medicine by virtue of section 90(7) if, and only if, the Chinese herbal medicine in question is--- (a) being used for the purpose of administering to a patient under his direct care; and

(b) dispensed on a prescription given by him and at the premises where he practises.

(5) Nothing in section 119 shall apply in respect of a proprietary Chinese medicine which is---

(a) imported by a wholesaler in proprietary Chinese medicines for the purpose of re-exporting by the same wholesale dealer; or

(b) imported by a holder of a valid certificate for clinical trial and medicinal test issued under section 129 and to be used for the purposes of the clinical trial or medicinal test to which the certificate relates.

(6) Nothing in sections 119 and 131 shall apply in respect of a proprietary Chinese medicine which is---

(a) compounded by or under the supervision of a registered Chinese medicine practitioner, a listed Chinese medicine practitioner or a person who continues to practise Chinese medicine by virtue of section 90(7) at the premises where he practises if, and only

if, such proprietary Chinese medicine is being used for the purpose of administering or supplying to a patient under his direct care; (b) individually prepared or compounded---

(i) by a person nominated under section 114(2)(b)(i) or (ii); or

(ii) under the supervision of such person,

at the premises in respect of which a retailer licence is in force and in accordance with a prescription given by a registered Chinese medicine practitioner, a listed Chinese medicine practitioner or a person who continues to practise Chinese medicine by virtue of section 90(7).

(7) Nothing in sections 109(2), 110, 111(2) and 134 shall apply to a person licensed under section 132 as a manufacturer of proprietary Chinese medicines if, and only if, the Chinese herbal medicines or proprietary Chinese medicines in question are imported or obtained by the manufacturer as raw materials for the purpose of manufacturing his own products.

(8) Nothing in section 134 shall apply to a person licensed under section 132 as a manufacturer of proprietary Chinese medicines if and only if he sells by way of wholesale the proprietary Chinese medicine manufactured by himself.

158. Service of notices and orders

Any notice or order required to be served under this Ordinance may be served by delivering a copy---

(a) personally; or

(b) by post or by registered post addressed to the last known address of the business or residence of the person to be served or his address as recorded in the Register.

159. Fees not repayable

No refund shall be made to any person or institution of any prescribed fee or any part of any prescribed fee paid under this Ordinance.

160. Regulations

(1) The Chief Executive in Council may by regulation provide for---

(a) any fee required to be paid under this Ordinance and, in the case of fees for practising certificates issued under this Ordinance, the imposition of a surcharge for late payment of any such fee;

(b) the disposal of any fee or surcharge paid or recovered under this Ordinance.

(2) Any fee or surcharge prescribed under subsection (1)---

(a) may be fixed at levels sufficient to effect the recovery of expenditure incurred, or likely to be incurred, by the Council, boards, committees and Government in performing their functions;

(b) shall not be limited by reason only of the amount of administrative or other costs incurred, or likely to be incurred, by the Council, boards, committees and Government in providing any service or otherwise performing any function under this Ordinance as regards any particular person or in providing any service which is of a particular class or description.

(3) Regulations made under subsection (1)(a) may provide that the amount of any fee or surcharge may be fixed by reference to a scale prescribed in the regulations, and for the payment of different fees or surcharges by or in relation to different categories of Chinese medicine practitioners or persons.

(4) The Secretary may by regulation provide for---

(a) the duties of the Registrar;

(b) the duties of the Council secretary; the secretaries of the Practitioners Board and the Medicines Board;

(c) the duties of the legal advisers to the Council, boards and committees.

(5) With the approval of the Secretary, the Council may by regulation provide for---

(a) the fixing of a quorum for meetings of the Council, boards and committees unless otherwise provided for under this Ordinance;

(b) the procedure to be followed in relation to Chinese medicine practitioners regarding---

(i) the receipt of complaints or information against a registered Chinese medicine practitioner which may be inquired into by the Practitioners Board;

(ii) the submission of complaints or information against a registered Chinese medicine practitioner to the Disciplinary Committee of Chinese Medicine Practitioners;

(iii) the consideration of any complaints or information against a registered Chinese medicine practitioner by the Disciplinary Committee of Chinese Medicine Practitioners;

(iv) the formulation of charges arising out of the complaints or information;

(v) the reference of cases arising out of complaints or information to the Practitioners Board by the Disciplinary Committee of Chinese Medicine Practitioners;

(vi) disciplinary inquiries against a registered Chinese medicine practitioner held by the Practitioners Board;

(c) the procedure to be followed in relation to Chinese herbal medicines and proprietary Chinese medicines regarding---

(i) the receipt of complaints or information concerning a licensed Chinese medicines trader which may be considered by the Medicines Board;

(ii) the submission of complaints or information concerning a licensed Chinese medicines trader to the Regulatory Committee of Chinese Medicines Traders;

(iii) the consideration of any complaints or information concerning a licensed Chinese medicines trader by the Regulatory Committee of Chinese Medicines Traders;

(iv) the submission of any complaints or information concerning a licensed Chinese medicines trader and the recommendation of the Regulatory Committee of Chinese Medicines Traders to the Medicines Board;

(v) the consideration of the findings and recommendations of the Regulatory Committee of Chinese Medicines Traders by the Medicines Board;

(d) the procedure to be followed in relation to---

(i) appeals held by the Council under this Ordinance;

(ii) inquiries or reviews held by the Practitioners Board under this Ordinance;

(iii) reviews held by the Medicines Board under this Ordinance;

(e) certificates, forms or other documents required for the purposes of this Ordinance, including the payment of a fee for their

issue;

(f) the format, procedures and any matter ancillary or related to the registration of Chinese medicine practitioners, the Licensing Examination and the transitional arrangements for Chinese medicine practitioners under this Ordinance;

(g) licensing requirements in respect of an application for---

(i) a wholesaler licence in---

(A) Chinese herbal medicines;

(B) proprietary Chinese medicines;

(ii) a retailer licence;

(iii) a manufacturer licence;

(h) practising conditions or duties which are applicable to the following categories of licence holder---

(i) a wholesaler licence in---

(A) Chinese herbal medicines;

(B) proprietary Chinese medicines;

(ii) a retailer licence;

(iii) a manufacturer licence;

(i) requirements regarding the experience and knowledge of a person nominated under sections 114(2)(b) and 132(1)(b);

(j) the period of any licence issued or renewed under this Ordinance;

(k) the period of any certificate issued or renewed under this Ordinance;

(l) requirements regarding the form and quality of, the labelling

of, and the display of distinctive marks on, containers and packages of Chinese herbal medicines or proprietary Chinese medicines;

(m) requirements and conditions for the import, export, packaging, transport, storage, record-keeping, processing, acquisition, sale, dispensing and disposal of any Chinese herbal medicines;

(n) requirements and conditions for the import, export, packaging, transport, storage, record-keeping, acquisition, sale, manufacture and disposal of any proprietary Chinese medicines;

(o) requirements for package inserts which are supplied, or are intended to be supplied, with proprietary Chinese medicines;

(p) particulars to be registered for any proprietary Chinese medicines;

(q) exempting any Chinese herbal medicines, proprietary Chinese medicines or Chinese medicines traders from the provisions of this Ordinance.

(6) Without prejudice to the generality of subsections (4) and (5), regulations made under those subsections may---

(a) require information, particulars and documents for the purposes of this Ordinance to be submitted and to be in such form as may be prescribed and require matters or documents for those purposes to be supported by statutory declarations or such other declarations as specified or approved by the Council;

(b) generally provide for the carrying into effect the provisions of this Ordinance.

(7) Any regulation made under this section may provide that a contravention of any provisions therein shall be an offence and may prescribe penalties for such offence not exceeding a fine at level 6 and imprisonment for 2 years.

SCHEDULE 1 [ss. 2, 109, 110,

112, 113 & 146

& Schs. 3 & 4]

Chinese Herbal Medicines

Name Description

Arsenic trioxide (砒霜) medicinal

Arsenolite (砒石) Mineral of oxides of Arsenolite or the processed product of Arsenopyrite or Realgar, medicinal

Calomelas (輕粉) Crystal of mercurous chloride, medicinal

Cinnabaris (朱砂) Mineral of sulphides of Cinnabar group, medicinal

Flos Daturae Metelis (洋金花) Flower of Datura metel L.

Flos Rhododendri Mollis (鬧羊花) Flower of Rhododendron mole G. Don

Huechys (紅娘蟲) Body of Huechys sanguinea De Geer.

Hydrargyri Oxydum Rubrum (紅粉) Red mercuric oxide, medicinal

Lytta (青娘蟲) Body of Lytta caraganae Pallas

Mercurous chloride and mercuric chloride Crystal of mercurous chloride and mercuric

(白降丹) chloride, medicinal

Mercury (水銀) medicinal

Mylabris (斑蝥) Body of Mylabris phalerata Pallas or Mylabris

cichorii Linnaeus

Orpiment (雌黃) Mineral of sulphides of Orpiment group, medicinal

Radix Aconiti Brachypodi or Radix Root tuber of Aconitum brachypodum Diels, Aconiti

Szechenyiani (雪上一枝蒿) Aconitum pendulum Busch (Aconitum

szechenyianum Gay.) or Aconitum subrosullatum Hand. Mazz. (Aconitum nagarum Stapf var. lasiandrum M. T. Wang)

Radix or Rhizoma Podophylli emodis, ` Rhizome or root of Podophyllum emodi (Wall.)

or Radix or Rhizoma Dysosmatis Ying, Dysosma versipellis (Hance) M. Cheng

(鬼臼 (桃耳七、八角蓮)) or Dysosma pleiantha (Hance) Woodson

Radix Sophorae Tonkinensis (山豆根) Root or rhizome of Sophora tonkinensis Gapnep.

Realgar (雄黃) Mineral of sulphides of Realgar group, medicinal

Unprocessed Fructus Crotonis (生巴豆) Unprocessed ripe fruit or seed of Croton tiglium L.

Unprocessed Radix Aconiti Kusnezoffii Unprocessed root tuber of Aconitum

(生草烏) Kusnezoffii Reichb.

Unprocessed Radix Aconiti Lateralis Unprocessed daughter root of Aconitum

(生附子) carmichaeli Debx.

Unprocessed Radix Aconiti (生川烏) Unprocessed parent root tuber of Aconitum carmichaeli Debx.

Unprocessed Radix Euphorbiae Unprocessed root of Euphorbia fischeriana

Fischerianae, Radix Euphorbiae Steud, Euphorbia ebracteolata Hayata or

Ebracteolatae or Radix Stellerae (生狼毒) Stellera chamaejasme L.

Unprocessed Radix Kansui (生甘遂) Unprocessed root tuber of Euphorbia Kansui T. N. Liou ex T. P. Wang

Unprocessed Resina Garciniae Morellae Unprocessed gum-resin of Garcinia morella

(生藤黃) Desv.

Unprocessed Rhizoma Arisaematis (生天南星) Unprocessed tuber of Arisaema erubescens

(Wall.) Schott., Arisaema heterophyllum Bl. or Arisaema amurense Maxim.

Unprocessed Rhizoma Pinelliae (生半夏) Unprocessed tuber of Pinellia ternata (Thunb.) Breit.

Unprocessed Rhizoma Typhonii or Radix Unprocessed tuber of Typhonium giganteum

Aconiti Coreani (生白附子(禹白附、關白附)) Engl. or root tuber of Aconitum

coreanum (Levl.) Raipaics

Unprocessed Semen Euphorbiae (生千金子) Unprocessed ripe seed of Euphorbia lathyris L.

Unprocessed Semen Hyoscyami (生天仙子) Unprocessed ripe seed of Hyoscyamus niger L.

Unprocessed Semen Strychni (生馬錢子) Unprocessed ripe seed of Strychnos nux-vomica L. or

Strychnos pierriana A. W. Hill

Venenum Bufonis (蟾酥) Secretion of Bufo bufo gargarizans Cantor or Bufo melanostictus Schneider

SCHEDULE 2 [ss. 2, 111, 112,

113 & 146 &

Schs. 3 & 4]

Chinese Herbal Medicines

Name Description

Agkistrodon (蘄蛇) Body of Agkistrodon acutus (Guenther)

Arisaema cum Bile (膽南星) Fine powder of processed Rhizoma Arisaematis with bile of ox, sheep or pig, or fine powder of unprocessed Rhizoma Arisaematis fermented with bile of ox, sheep or pig

Aspongopus (九香蟲) Body of Aspongopus chinensis Dallas

Asteriscus Pseudosciaenae (魚腦石) Otolith of Pseudosciaena crocea (Richardson) or

Pseudosciaena polyactis Bleeker

Benzoinum (安息香) Resin of Styrax tonkinensis (Pierre) Craib ex Hart

Bombyx Batryticatus (僵蠶) Body of 4th-5th stage larva of Bombyx mori L. died of infection or

artificial infection of Benvaria bassianal (Bals.) Vuill

Bulbus Fritillariae Cirrhosae (川貝母) Bulb of Fritillaria cirrhosa D. Don, Fritillaria

unibracteata Hsiao et K.C. Hsia, Fritillaria przewalskii Maxim or Fritillaria delavayi Franch

Bulbus Fritillariae Hupehensis (湖北貝母) Bulb of Fritillaria hupehensis Hsiao et K. C. Hsia

Bulbus Fritillariae Pallidiflorae (伊貝母) Bulb of Fritillaria walujewii Regel or Fritillaria pallidiflora Schrenk

Bulbus Fritillariae Thunbergii (浙貝母) Bulb of Fritillaria thunbergii Miq.

Bulbus Fritillariae Ussuriensis (平貝母) Bulb of Fritillaria ussuriensis Maxim

Bulbus Lycoridis Radiatae (石蒜) Bulb of Lycoris radiata (L' Herit.) Herb.

Cacumen Platycladi (側柏葉) Twig or leaf of Platycladus orientalis (L.) Franco

Cacumen Securinegae Suffruticosae (葉底珠) Young branch with leaf of Securinega

suffruticosa (Pall.) Rehd.

Cacumen Tamaricis (西河柳) Young twig and leaf of Tamarix chinensis Lour.

Calamina (爐甘石) Smithsonite of carbonate of calcite group

Calculus Bovis (牛黃) Gallstone of Bos taurus domesticus Gmelin

Calculus Equi (馬寶) Calculus of the gasto-intestinal tract or the urinary bladder of Equus caballus orientalis Noack

Calyx seu Fructus Physalis (錦燈籠) Persistent calyx or the persistent calyx with fruit of

Physalis alkekengi L. var. franchetii (Mast.) Makino

Caulis Akebiae (木通) Stem of Akebia quinata (Thunb.) Decne, Akebia trifoliata (Thunb.) Koidz.

or Akebia trifoliata (Thunb.) Koidz. var. australis (Diels) Rehd.

Caulis Ampelopsis Brevipedunculae (山葡萄) Stem of Ampelopisis brevipedunculata (Maxim.) Trautv.

Caulis Aristolochiae Manshuriensis (關木通) Stem of Aristolochia manshuriensis Kom.

Caulis Bambusae in Taeniam (竹茹) Middle shavings of stem of Bambusa tuldoides Munro,

Sinocalamus beecheyanus (Munro) McClure var. pubescens P. F. Li or Phyllostachys nigra (Lodd.)

Munro var. heenonis Stapf

Caulis Clematidis Armandii (川木通) Stem of Clematis armandii Franch. or Clematis montana

Buch.-Ham.

Caulis Entadae (過江龍) Stem of Entada phaseoloides (L.) Merr.

Caulis Erycibes (丁公藤) Stem of Erycibe obtusfolia Benth. or Erycibe schmidtii Craib

Caulis et Folium Piperis Hancei (山蒟) Stem and leaf of Piper hancei Maxim.

Caulis et Folium Schefflerae Arboricolae Stem or leaf of Schefflera arboricola Hayata

(七葉蓮)

Caulis Euphorbiae Antiquori (火殃簕) Stem of Euphorbia antiquorum L.

Caulis Fibraureae (黃藤) Stem of Fibraurea recisa Pierre

Caulis Gneti (買麻藤) Stem of Gnetum parvifolium (Warb.) C. Y. Cheng ex Chun [G. indicum

(Lour.) Merr.]

Caulis Hederae Sinensis (常春藤) Stem of Hedera nepalensis K. Koch var. sinensis (Tobl.) Rehd.

Caulis Impatientis (透骨草) Stem and branch of Impatiens balsamina L.

Caulis Lonicerae (忍冬藤) Stem and branch of Lonicera japonica Thunb.

Caulis Mahoniae (功勞木) Stem of Mahonia bealei (Fort.) Carr. or Mahonia fortunei (Lindl.)

Fedde

Caulis Perillae (紫蘇梗) Stem of Perilla frutescens (L.) Britt.

Caulis Piperis Kadsurae (海風藤) Stem of Piper kadsura (Choisy) Ohwi.

Caulis Polygoni Multiflori (首烏藤) Stem of Polygonum multiflorum Thunb.

Caulis Sargentodoxae (大血藤) Stem of Sargentodoxa cuneata (Oliv.) Rehd. Et Wils.

Caulis Sinomenii (青風藤) Stem of Sinomenium acutum (Thunb.) Rehd. et Wils. or Sinomenium

acutum (Thunb.) Rehd. et Wils. var. cinereum Rehd. et Wils.

Caulis Spatholobi (雞血藤) Stem of Spatholobus suberectus Dunn

Caulis Tinosporae (寬根藤) Stem of Tinospora sinensis (Lour.) Merr.

Caulis Trachelospermi (絡石藤) Stem with leaf of Trachelospermum jasminoides (Lindl.) Lem.

Cera Chinensis (蟲白蠟) Wax secreted by Ericerus pela (Chavannes) Guerin which dwells at the stem and branch of Frasxinus chinencis Roxb. Ligustrum lucidum Ait. or other species of the genus Legustru.

Colla Corii Asini (阿膠) Processed solid glue from the skin of Equus asinus Linnaeus

Concha Arcae (瓦楞子) Shell of Arca subcrenata Lischle, Arca granosa Linnaeus or Arca inflata Reeve

Concha Haliotidis (石決明) Shell of Haliotis diversicolor Reeve, Haliotis discus hannai Ino, Haliotis ovina Gmelin, Haliotis ruber (Leach), Haliotis asinina Linnaeus or Haliotis laevigata (Donovan)

Concha Margaritifera Usta (珍珠母) Shell of Hyriopsis cumingii (Lea), Cristaria plicata (Leach) or Pteria martensii (Dunker)

Concha Mauritiae Arabicae (紫貝齒) Shell of Mauritia (Arabica) arabica (Linnaeus)

Concha Meretricis sue Cyclinae (蛤殼) Shell of Meretrix meretrix Linnaeus or Cyclina sinensis Gmelin

Concretio Silicea Bambusae (天竺黃) Masses of secretion in the stem of Bambusa textilis

McClure or Schizostachyum chinense Rendle

Cordyceps (冬蟲夏草) Composite substance of the stroma of Cordyceps sinensis (Berk.) Sacc. parasitized on the larva of some species of insects of Fam. Hypocreaceae, and the dead caterpillar

Corium Erinacei seu Hemiechianus (刺皮) Skin of Erinaceus europaeus Linnaeus, Hemiechianus dauricus Sundevall or Hemiechianus auritus Gmelin

Cornu Bubali (水牛角) Horn of Bubalus bubalis Linnaeus

Cornu Cervi (鹿角) Ossified antler, or antler base which dropped off in the next spring after the pilose antler is cut, of Cervus elaphus Linnaeus or Cervus nippon Temminck

Cornu Cervi Degelatinatum (鹿角霜) Degelatined antler of Cervus nippon Temminch or Cervus elaphus Linnaeus

Cornu Cervi Pantotrichum (鹿茸) Young pilose antler of male Cervus nippon Temminch or Cervus elaphus Linnaeus

Cornu Saigae Tataricae (羚羊角) Horn of Saiga tatarica Linnaeus

Cortex Acanthopanacis (五加皮) Root bark of Acanthopanax gracilistylus W. W. Smith

Cortex Ailanthi (椿皮) Root bark or stem bark of Ailanthus altissima (Mill.) Swingle

Cortex Albiziae (合歡皮) Stem bark of Albizia julibrissin Durazz.

Cortex Cinchonae (金雞納皮) Bark of Cinchona ledgeriana Moens., Cinchona succirubra Pavon or Cinchona officinalis L.

Cortex Dictamni (白鮮皮) Root bark of Dictamnus dasycarpus Turcz.

Cortex Eucommiae (杜仲) Stem bark of Eucommia ulmoides Oliv.

Cortex Fraxini (秦皮) Branch bark or stem bark of Fraxinus rhynchophylla Hance, Frazinus chinensis Rixb., Fraxinus chinensis Roxb. Var. acuminata Lingelsh or Fraxinus stylosa Lingelsh

Cortex Hibisci (川槿皮) Stem bark or root bark of Hibiscus syriacus L.

Cortex Ilicis Rotundae (救必應) Bark of Ilex rotunda Thunb.

Cortex Illicii (地楓皮) Stem bark of Illicium difengpi K. I. B. et K. I. M

Cortex Kadsurae Radicis (紫荊皮) Root bark of Kadsura longipedunculata Finet et Gagnep. (K. peltigera Rehd. et Wils.)

Cortex Lycii (地骨皮) Root bark of Lycium chinense Mill. or Lycium barbarum L.

Cortex Magnoliae Officinalis (厚樸) Stem bark, root bark or branch bark of Magnolia officinalis Rehd. et Wils. or Magnolia officinalis Rehd. et Wils. var. biloba Rehd. et Wils.

Cortex Meliae (苦楝皮) Stem bark or root bark of Melia toosendan sieb. Et Zucc. or Melia azedarach L.

Cortex Mori (桑白皮) Root bark of Morus alba L.

Cortex Moutan (牡丹皮) Root bark of Paeonia suffruticosa Andr.

Cortex Periplocae (香加皮) Root bark of Periploca sepium Bge.

Cortex Phellodendri (黃柏) Bark of Phellodendron chinense Schneid or Phellodendron amurense Rupr

Cortex Pseudolaricis (土荊皮) Root bark or stem bark near the root of Pseudolarix kaempferi Gord.

Cortex Schefflerae Octophyllae (鴨腳木) Root bark of Schefflera octophylla (Lour.) Harms

Cortex Ulmi Parvifoliae (榔榆皮) Bark or root bark of Ulmus parvifolia Jacq.

Crinis Carbonisatus (血餘炭) Carbonized human hair

Eupolyphaga seu Steleophaga (土鱉蟲) Body of female Eupolyphaga sinensis Walker or Steleophaga plancyi (Boleny)

Faeces Leporis (望月砂) Faeces of Lepus sinensis Gray, Lepus mandshuricus Radde or Lepus oiostolus Hodgson

Faeces Trogopterori (五靈脂) Faeces of Trogopterus xanthipes Milne-Edwards

Faeces Vespertilionis (夜明砂) Faeces of Vespertilio superans Thomas

Flos Albiziae (合歡花) Inflorescence of Albizia julibrissin Durazz

Flos Buddlejae (密蒙花) Flower bud or inflorescence of Buddleja officinalis Maxim

Flos Campsis (凌霄花) Flower of Campsis grandiflora (Thunb.). K. Schum. or Campsis radicans (L.) Seem.

Flos Celosiae Cristatae (雞冠花) Capitulum of Celosia cristata L.

Flos Chimonanthi Praecocis (臘梅花) Flower bud of Chimonanthus praeco (L.) Link

Flos Eriocauli (穀精草) Capitulum with peduncle of Eriocaulon buergerianum Koern.

Flos Farfarae (款冬花) Flower bud of Tussilago farfara L.

Flos Genkwa (芫花) Flower bud of Daphne genkwa Sieb. Et Zucc.

Flos Hibisci Rosae-Sinensis (扶桑花) Flower of Hibiscus rosa-sinensis L.

Flos Inulae (旋覆花) Capitulum of Inula japonica Thunb. or Inula britannica L.

Flos Jasmini (素馨花) Flower bud of Jasminum officinale L. var. grandiflorum (L.) Kobuski

Flos Magnoliae (辛夷) Flower bud of Magnolia biondii Pamp., Magnolia denudata Desr. or Magnolia sprengeri Pamp.

Flos Magnoliae Officinalis (厚樸花) Flower bud of Magnolia officinalis Rehd. et Wils. or Magnolia officinalis Rehd. et Wils. var. biloba Rehd. et Wils.

Flos Rosae Chinensis (月季花) Flower of Rosa chinensis Jacq.

Fluoritum (紫石英) Fluoride mineral of fluorite group

Folium Aconiti Kusnezoffii (草烏葉) Leaf of Aconitum kusnezoffii Reichb.

Folium Apocyni Veneti (羅布麻葉) Leaf of Apocynum venetum L.

Folium Artemisiae Argyi (艾葉) Leaf of Artemisia argyi Levl. et Vant.

Folium Callicarpae Formosanae (紫珠葉) Leaf of Callicarpa formosana Rolfe

Folium et Cacumen Breyniae Fruticosae Young branch with leaf of Breynia fruticosa

(黑面神) (L.) Hook. f.

Folium et Cacumen Murrayae (九里香) Leaf or young twig of Murraya exotica L.or Murraya paniculata (L.) Jack

Folium et Ramulus Evodiae (三叉苦) Branch and leaf of Evodia lepta (Spreng.) Merr.

Folium Ginkgo (銀杏葉) Leaf of Ginkgo biloba L.

Folium Ginseng (人參葉) Leaf of Panax ginseng C. A. Mey.

Folium Glochidii Eriocarpi (漆大姑) Leaf of Glochidion eriocarpum Champ.

Folium Hibisci Mutabilis (木芙蓉葉) Leaf of Hibiscus mutabilis L.

Folium Ilicis Cornutae (枸骨葉) Leaf of Ilex cornuta Lindl.

Folium Isatidis (大青葉) Leaf of Isatis indigotica Fort.

Folium Lantanae Camarae (馬纓丹) Leaf of Lantana camara L.

Folium Nerii (夾竹桃葉) Leaf of Nerium indicum Mill

Folium Photiniae (石南葉) Leaf of Photinia serrulata Lindl

Folium Pini (松毛) Needle of Pinus massoniana Lamb., Pinus tabulaeformis Carr. or the same genus

Folium Polygoni Tinctorii (蓼大青葉) Leaf of Polygonum tinctorium Ait.

Folium Psidii Guajavae (番石榴葉) Leaf of Psidium guajava L.

Folium Psychotriae Rubrae (山大顏) Leaf of Psychotria rubra (Lour.) Poir.

Folium Pterocaryae Stenopterae (楓楊葉) Leaf of Pterocarya stenoptera DC.

Folium Pyrrosiae (石韋) Leaf of Pyrrosia sheareri (Bak.) Ching, Pyrrosia lingua (Thunb.)

Farwell or Pyrrosia petiolosa (Christ) Ching

Folium Rhododendri Daurici (滿山紅) Leaf of Rhododendron dauricum L.

Folium Sauropi (龍脷葉) Leaf of Saruopus rostratus Miq. (S. changianus S.Y. Hu)

Folium Sennae (番瀉葉) Leaflet of Cassia angustifolia Vahl or Cassia acutifolia Lelile

Folium Viticis Negundo (牡荊葉) Leaf of Vitex negundo L. var. cannabifolia (Sieb. Et Zucc.) Hand.-Mazz.

Fructus Akebiae (預知子) Almost ripe fruit of Akebia quinata (Thunb.) Decne., Akebia trifoliata (Thunb.) Koidz. or Akebia trifoliata (Thunb.) Koidz. var. australis (Diels) Rehd.

Fructus Alpiniae Oxyphyllae (益智) Ripe fruit of Alpinia oxyphylla Miq.

Fructus Amomi Rotundus (豆蔻) Ripe fruit of Amomum kravanh Pirre ex Gagnep. or Amomum compactum Soland ex Maton

Fructus Arctii (牛蒡子) Ripe fruit of Arctium lappa L.

Fructus Aristolochiae (馬兜鈴) Ripe fruit of Aristolochia contorta Bge. or Aristolochia debilis Sieb. et Zucc.

Fructus Aurantii (枳殼) Young fruit of Citrus aurantium L. or Citrus sinensis Osbeck

Fructus Aurantii Immaturus (枳實) Young fruit of Citrus aurantium L. or its cultivars or Citrus sinensis Osbeck

Fructus Broussonetiae (楮實子) Ripe fruit of Broussonetia papyrifera (L.) Vent.

Fructus Bruceae (鴉膽子) Ripe fruit of Brucea javanica (L.) Merr.

Fructus Carotae (南鶴蝨) Ripe fruit of Daucus carota L.

Fructus Carpesii (鶴蝨) Ripe fruit of Carpesium abrotanoides L.

Fructus Chebulae (訶子) Ripe fruit of Terminalia chebula Retz. or Terminalia chebula Retz. var. tomentella Kurt.

Fructus Cnidii (蛇床子) Ripe fruit of Cnidium monnieri (L.) Cuss.

Fructus Coriandri (芫荽子) Fruit of Coriandrum sativum L.

Fructus Corni (山茱萸) Ripe sarcocarp of Cornus officinalis Sieb. et Zucc.

Fructus Evodiae (吳茱萸) Almost ripe fruit of Evodia rutaecarpa (Juss.) Benth., Evodia rutaecarpa (Juss.) Benth. var. officinalis (Dode) Huang or Evodia rutaecarpa (Juss.) Benth. var. bodinieri (Dode) Huang

Fructus Fici Pumilae (薜荔果) Collective fruit of Ficus pumila L.

Fructus Forsythiae (連翹) Fruit of Forsythia suspensa (Thunb.) Vahl

Fructus Galangae (紅豆蔻) Ripe fruit of Alpinia galanga Willd.

Fructus Gleditsiae Abnormalis (豬牙皂) Sterile fruit of Gleditsia sinensis Lam.

Fructus Kochiae (地膚子) Ripe fruit of Kochia scoparia (L.) Schrad.

Fructus Leonuri (茺蔚子) Ripe fruit of Leonurus heterophyllus Sweet

Fructus Ligustri Lucidi (女貞子) Ripe fruit of Ligustrum lucidum Ait.

Fructus Liquidambaris (路路通) Ripe infructescene of Liquidambar formosana Hance

Fructus Litseae (蓽澄茄) Ripe fruit of Litsea cubeba (Lour.) Pers.

Fructus Malvae (冬葵果) Ripe fruit of Malva verticillata L.

Fructus Nandinae Domesticae (天竺子) Fruit of Nandina domestica Thunb.

Fructus Phyllanthi (餘甘子) Ripe fruit of Phyllanthus emblica L.

Fructus Piperis Longi (蓽) Almost ripe or ripe fruitspike of Piper longum L.

Fructus Podophylli (小葉蓮) Ripe fruit of Podophyllum emodi Wall.

Fructus Polygoni Orientalis (水紅花子) Ripe fruit of Polygonum orientale L.

Fructus Psoraleae (補骨脂) Ripe fruit of Psoralca corylifolin L.

Fructus Quisqualis (使君子) Ripe fruit of Quisqualis indica L.

Fructus Rosae Laevigatae (金櫻子) Ripe fruit of Rosa laevigata Michx.

Fructus Rubi (覆盆子) Fruit of Rubus chingii Hu

Fructus Sapindi Mukorossi (無患子) Fruit of Sapindus mukorossi Gaertn.

Fructus Schisandrae (五味子) Ripe fruit of Schisandra chinensis (Turcz.) Barll or Schisandra sphenanthera Rehd. et Wils.

Fructus seu Herba Physalis Pubescentis Fruit with calyx or any or whole part of (燈籠草) Physalis pubescens L.

Fructus Sophorae (槐角) Ripe fruit of Sophora japonica L.

Fructus Terminaliae Billericae (毛訶子) Ripe fruit of Terminalia billerica (Gaertn.) Roxb.

Fructus Toosendan (川楝子) Ripe fruit of Melia toosendan Sieb. et Zucc.

Fructus Tribuli (蒺藜) Ripe fruit of Tribulus terrestris L.

Fructus Trichosanthis (瓜蔞) Ripe fruit of Trichosanthes kirilowii Maxim, Trichosanthes rosthornii Harms

Fructus Tritici Levis (浮小麥) Cariopsis of Triticum aestivum L.

Fructus Tsaoko (草果) Ripe fruit of Amomum tsaoko Crevost et Lemaire

Fructus Ulmi Macrocarpae (蕪荑) Fruit of Ulmus macrocarpa Hance

Fructus Viticis (蔓荊子) Ripe fruit of Vitex trifolia L. var. simplicifolia Cham. or Vitex trifolia L.

Fructus Viticis Negundo (黃荊子) Fruit of Vitex negunod L. or Vitex negundo L. var. cannabifolia (Sieb. et Zucc.)

Hand.-Mazz.

Fructus Xanthii (蒼耳子) Ripe bur with involucre of Xanthium sibiricum Patr.

Galla Chinensis (五倍子) Gall produced by parasitic aphids of Melaphis chinensis (Bell) Baker on the leaf of Rhus chinensis Mill., Rhus potaninii Maxim. or Rhus punjabensis Stew. var. sinica (Diels) Rehd. et Wils, Melaphis chinensis (Bell) Baker

Gekko Swinhonis (壁虎) Body of Gekko japonicus (Dumeril et Bibron) or Gekko swinhonis Guenther

Gypsum Fibrosum Preparata (煅石膏) Calcined plaster stone of sulphate of plaster stone group

Haematitum (赭石) Mineral of oxide of corundum group

Halloysitum Rubrum (赤石脂) Mineral of silicate salt of polyhydrate kaolinate group

Herba Abri (雞骨草) Any or whole part of Abrus cantoniensis Hance

Herba Achyranthis Asperae (倒扣草) Any or whole part of Achyranthes aspera L.

Herba Aeschynomenes Indicae (田皂角) Any or whole part of Aeschynomene indica L.

Herba Agastaches (藿香) Aerial part of Agastache rugosus (Fisch. et Mey.) O. Ktze.

Herba Aglaonematis (廣東萬年青) Any or whole part of Aglaonema modestum Schott ex Engl.

Herba Agrimoniae (仙鶴草) Aerial part of Agrimonia pilosa Ledeb.

Herba Andrographitis (穿心蓮) Aerial part of Andrographis paniculata (Burm. f.) Nees

Herba Antenoronis Neofiliformis (金綫草) Any or whole part of Antenoron neofiliforme (Nakai) Hara

Herba Ardisiae Japonicae (矮地茶) Any or whole part of Ardisia japonica (Hornsted) Blume

Herba Aristolochiae (天仙藤) Aerial part of Aristolochia debilis Sieb. et Zucc. or Aristolochia contorta Bge.

Herba Aristolochiae Mollissimae (尋骨風) Any or whole part of Aristolochia mollissima Hance

Herba Artemisiae Annuae (青蒿) Aerial part of Artemisia annua L

Herba Artemisiae Anomalae (劉寄奴) Aerial part of Artemisia anomala S. Moore

Herba Artemisiae Scopariae (茵陳) Aerial part of Artemisia scoparia Waldst. et Kit. or Artemisia capillaris Thunb.

Herba Asari (細辛) Any or whole part of Asarum heterotropoides Fr. var. mandshuricum (maxim.) Kitag., Asarum sieboldii Miq. var. seoulense Nakai or Asarum sieboldii Miq.

Herba Belladonnae (顛茄草) Any or whole part of Atropa belladonna L.

Herba Bidentis Bipinnatae or Herba Any or whole part of Bidens bipinnata L. or Bidentis Pilosae (鬼針草) Bidens. pilosa L.

Herba Blumeae Balsamiferae (大風艾) Any or whole part of Blumea balsamifera (L.) DC.

Herba Bryophylli Pinnati (落地生根) Any or whole part of Bryophyllum pinnatum (L.f.) Oken [Kalanchoe pinnata (Lam.) Pers.]

Herba Casythae Filiformis (無根藤) Any or whole part of Cassytha filiformis L.

Herba Catharanthi Rosei (長春花) Any or whole part of Catharanthus roseus (L.) G. Don [Vinca rosea L. Lochnera rosea (L.) Reichb.]

Herba Centellae (積雪草) Any or whole part of Centella asiatica (L.) Urb.

Herba Centipedae (鵝不食草) Any or whole part of Centipeda minima (L.) A. Braun et Aschers.

Herba Chenopodii (土荊芥) Any or whole part with fruit of Chenopodium ambrosioides L.

Herba Cirsii (小薊) Aerial part of Cirsium setosum (Willd.) MB.

Herba Cissampelotis (亞乎奴) Any or whole part of Cissampelos pareira L. var. hirsuta (Buch. ex DC) Forman

Herba Cistanches (肉蓯蓉) Fleshy stem with scale of Cistanche deserticola Y. C. Ma

Herba Clinopodii (斷血流) Aerial part of Clinopodium polycephalum (Vaniot) C. Y. Wu et

Hsuan ex Hsuan or Clinopodium chinense (Benth.) O. Kuntze

Herba Clinopodii Gracilis (剪刀草) Any or whole part of Clinopodium gracile (Benth.) Matsum. (Calamintha gracilis Benth.)

Herba Commlinae (鴨跖草) Aerial part of Commelina ommunis L.

Herba Corydalis Bungeanae (地丁草) Any or whole part of Corydalis bungeana Turcz.

Herba Crotalariae Mucronatae (豬屎豆) Seed, or any or whole part of Crotalaria mucronata Desv.

Herba Cymbopogonis (蕓香草) Aerial part of Cymbopogon distans (Nees) W. Wats

Herba Cynomorii (鎖陽) Fleshy stem of Cynomorium songaricum Rupr.

Herba Damnacanthi (虎刺) Any or whole part of Damnacanthus indicus Gaertn. f.

Herba Dendrobii (石斛) Stem of Dendrobium loddigesii Rolfe., Dendrobium fimbriatum Hook. var. oculatum Hook, Dendrobium chrysanthum Wall., Dendrobium candidum Wall. Ex Lindl. or Dendrobium nobile Lindl

Herba Desmodii Styracifolii (廣金錢草) Aerial part of Desmodium styracifolium (Osb.) Merr.

Herba Dianthi (瞿麥) Aerial part of Dianthus superbus L. or Dianthus chinensis L.

Herba Dichondrae Repentis (馬蹄金) Any or whole part of Dichondra repens Forst.

Herba Duchesneae Indicae (蛇莓) Any or whole part of Duchesnea indica (Andr.) Focke

Herba Ecliptae (墨旱蓮) Aerial part of Eclipta prostrata L.

Herba Eleocharitis (通天草) Aerial part of Eleocharis dulcis (Burm.f.) Trin. ex Henschel [E. tuberosa (Roxb.) Roem. et Schult.]

Herba Elephantopi (地膽頭) Any or whole part of Elephantopus scaber L.

Herba Eleusines Indicae (牛筋草) Any or whole part of Eleusine indica (L.) Gaertn

Herba Emiliae (一點紅) Any or whole part of Emilia sonchifolia (L.) DC.

Herba Ephedrae (麻黃) Herbaceous stem of Ephedra sinica Stapf, Ephedra intermedia Schrenk et C. A. Mey. or Ephedra equisetina Bge

Herba Epimedii (淫羊藿) Aerial part of Epimedium brevicornum Maxim, Epimedium sagittatum (Sieb. et Zucc.) Maxim., Epimedium pubescens Maxim., Epimedium wushanense T. S. Ying or Epimedium koreanum Nakai

Herba Epimeredis Indicae (防風草) Any or whole part of Epimeredi indica (L.) Rothm. [Anisomeles indica (L.) O. ktze., A. ovata R. Br.]

Herba Equiseti Hiemalis (木賊) Aerial part of Equisetum hiemale L.

Herba Erodii or Herba Geranii (老鸛草) Aerial part of Erodium stephanianum Willd. or Geranium wilfordii Maxim.

Herba Eupatorii (佩蘭) Aerial part of Eupatorium fortunei Turcz.

Herba Euphorbiae Hirtae (飛楊草) Any or whole part of Euphorbia hirta L.

Herba Euphorbiae Humifusae (地錦草) Any or whole part of Euphorbia numifusa Willd or Euphorbia maculata

Herba Euphorbiae Thymifoliae (小飛楊草) Any or whole part of Euphorbia thymifolia L.

Herba Gelsemii Elegantis (斷腸草) Any or whole part of Gelsemium elegans (Gardn. et Champ.) Benth.

Herba Gendarussae (小駁骨) Any or whole part of Gendarussa valgaris Nees (Justicia gendarussa L.f.)

Herba Geranii Caroliniani (野老鸛草) Any or whole part of Geranium carolinianum L.

Herba Glechomae (連錢草) Aerial part of Glechoma longituba (Nakai) Kupr.

Herba Gnaphalii Affinis (鼠曲草) Any or whole part of Gnaphalium affine D. Don (G. multiceps Wall. ex DC.)

Herba Gynostemmatis (絞股藍) Any or whole part of Gynostemma pentaphylla (Thunb.) Makino

Herba Hedyotidis Chrysotrichae (黃毛耳草) Any or whole part of Hedyotis chrysotricha (Palibin) Merr. [Oldenlandia chrysotricha (Palibin) Chun]

Herba Hedyotidis Corymbosae (水綫草) Any or whole part of Hedyotis corymbosa (L.) Lam. (Oldenlandia corymbosa L.)

Herba Houttuyniae (魚腥草) Aerial part of Houttuynia cordata Thunb.

Herba Hyperici (紅旱蓮) Aerial part of Hyperieum ascyron L.

Herba Hyperici Erecti (小連翹) Any or whole part of Hypericum erectum Thunb.

Herba Hyperici Japonici (田基黃) Any or whole part of Hypericum japonicum Thunb.

Herba Inulae (金沸草) Aerial part of Inula linariifolia Turcz., Inula japonica Thunb.

Herba Junci Setchuensis (龍鬚草) Aerial part of Juncus setchuensis Buch. var. effusoides Buch.

Herba Kulanchoes Laciniatae (伽藍菜) Any or whole part of Kalanchoe laciniata (L.) DC

Herba Leonuri (益母草) Aerial part of Leonurus heterophyllus Sweet

Herba Lespedezae Cuneatae (鐵掃帚) Any or whole part of Lespedeza cuneata (Dum.-Cours.) G. Don

Herba Lobeliae Chinensis (半邊蓮) Any or whole part of Lobelia chinensis Lour.

Herba Lophatheri (淡竹葉) Stem and leaf of Lophatherum gracile Brongn.

Herba Lycopi (澤蘭) Aerial part of Lycopus lucidus Turcz. var. hirtus Regel

Herba Lycopodii (伸筋草) Any or whole part of Lycopodium japonicum Thunb.

Herba Lysimachiae (金錢草) Any or whole part of Lysimachia christinae Hance

Herba Malvastri Coromandeliani (黃花棉) Any or whole part of Malvastrum coromandelianum (L.) Garcke

Herba Melastomatis Candii (野牡丹) Any or whole part of Melastoma candidum D. Don

Herba Melastomatis Dodecandri (地菍) Any or whole part of Melastoma dodecandrum Lour.

Herba Orostachyos (瓦松) Any or whole part of Orostachys fimbriatus (Turcz.) Berger or Orostachys erubescens (Maxim.) Ohwi (etc)

Herba Paederiae (雞屎藤) Any or whole part of Paederia scandens (Lour.) Merr.

Herba Patriniae (敗醬草) Any or whole part of Patrinia scabiosaefolia Fisch. or Patrinia villosa (Thunb.) Juss.

Herba Pholidotae Chinensis (石仙桃) Any or whole part of Pholidota chinensis Lindl.

Herba Phyllanthi Urinariae (葉下珠) Any or whole part of Phyllanthus urinaria L.

Herba Piperis Sarmentosi (假蒟) Aerial part of Piper sarmentosum Roxb.

Herba Plantaginis (車前草) Any or whole part of Plantago asiatica L. or Plantago depressa Willd.

Herba Polygalae Chinensis (大葉金不換) Any or whole part of Polygala chinensis L.

Herba Polygalae Japonicae (瓜子金) Any or whole part of Polygala japonica Houtt.

Herba Polygoni Avicularis (萹蓄) Aerial part of Polygonum aviculare L.

Herba Polygoni Chinensis (火炭母) Any or whole part of Polygonum chinense L.

Herba Polygoni Perfoliati (杠板歸) Any or whole part of Polygonum perfoliatum L.

Herba Potentillae Chinensis (委陵菜) Any or whole part of Potentilla chinensis Ser.

Herba Potentillae Discoloris (翻白草) Any or whole part with root of Potentilla discolor Bunge

Herba Pouzolziae Zeylanicae (霧水葛) Any or whole part of Pouzolzia Zeylanica (L.) Benn.

Herba Pteridis Multifidae (鳳尾草) Any or whole part of Pteris multifida Poir

Herba Pteridis Semipinnatae (半邊旗) Any or whole part of Pteris semipinnata L.

Herba Pyrolae (鹿銜草) Any or whole part of Pyrola calliantha H. Andres or Pyrola decorata H. Andres

Herba Rabdosiae Lophanthoidis (溪黃草) Any or whole part of Rabdosia lophanthoides (Buch.-Ham. ex D. Don) Hara (plectranthus striatus Benth.)

Herba Ranunculi Japonici (毛茛) Any or whole part of Ranunculus japonicus Thunb.

Herba Saginae Japonicae (漆姑草) Any or whole part of Sagina japonica (Sw.) Ohwi

Herba Salviae Chinensis (石見穿) Any or whole part of Salvia chinensis Benth.

Herba Salviae Plebeiae (荔枝草) Any or whole part of Salvia plebeia R. Br.

Herba Sambuci Chinensis (陸英) Stem and leaf of Sambucus chinensis Lindl.

(S. javanica auct. non Reinw. ex Blume)

Herba Sarcandrae (腫節風) Any or whole part of Sarcandra glabra (Thunb.) Nakai [Chloranthus glaber (Thunb.) Makino]

Herba Saussureae Involucratae (雪蓮花) Any or whole part of Saussurea involucrata Kar. et Kir.

Herba Saxifragae (虎耳草) Any or whole part of Saxifraga stolonifera (L.) Meerb.

Herba Schizonepetae (荊芥) Aerial part of Schizonepeta tenuifolia Briq.

Herba Scutellariae Barbatae (半枝蓮) Any or whole part of Scutellaria barbata D. Don

Herba Sedi (垂盆草) Any or whole part of Sedum sarmentosum Bunge

Herba Selaginellae (卷柏) Any or whole part of Selaginella tamariscina (Beauv.) Spring or Selaginella puluinata (Hook. et Grev.)

Herba Selaginellae Doederleinii (石上柏) Any or whole part of Selaginella doederleinii Hieron.

Herba Senecionis Scandentis (千里光) Any or whole part of Senecio scandens Buch.-Ham. (S.chinensis DC.)

Herba Setariae Viridis (狗尾草) Any or whole part of Setaria viridis (L.) Beauv.

Herba seu Radix Amaranrhi (刺莧菜) Any or whole part of Amaranthus spinosus L.

Herba seu Radix Cirsii Japonici (大薊) Aerial part or root of Cirsium japonicum DC.

Herba Sidae Rhombifoliae (黃花母) Any or whole part of Sida rhombifolia L.

Herba Siegesbeckiae (豨簽草) Aerial part of Siegesbeckia orientalis L., Siegesbeckia pubescens Makino or Siegesbeckia glabrescens Makino

Herba Solani Lyrati (白英) Any or whole part of Solanum lyratum Thunb. [S. dulcamara L. var. lyratum (Thunb.) Sieb. et Zucc.]

Herba Solani Nigri (龍葵) Any or whole part of Solanum nigrum L.

Herba Solidaginis (一枝黃花) Any or whole part of Solidago decurrens Lour. [S. virgaurea L. var. leiocarpa (Benth.) A. Gray]

Herba Speranskiae Tuberculatae (珍珠透骨草) Any or whole part of Speranskia tuberculata (Bunge) Baill.

Herba Spirodelae (浮萍) Any or whole part of Spirodela polyrhiza (L.) Schleid.

Herba Stephaniae Longae (糞箕篤) Any or whole part of Stephania longa Lour.

Herba Swertiae Mileensis (青葉膽) Any or whole part of Swertia mileensis T. N. Ho et W. L. Shih

Herba Taxilli (桑寄生) Stem and branch with leaf of Taxillus chinensis (DC.) Danser

Herba Verbenae (馬鞭草) Aerial part of Verbena officinalis L.

Herba Veronicae (一支香) Any or whole part of Veronica linariifolia

Pall. ex Link [V. spuria (non L.) senus Romp. p. p. ]

Herba Veronicastri (腹水草) Any or whole part of Veronicastrum axillare (Sieb. et Zucc.)

Yamazaki or Veronicastrum stenostachyum (Hemsl.) Yamazaki

Herba Violae (紫花地丁) Any or whole part of Herb of Viola yedoensis Makino

Herba Visci (槲寄生) Stem and branch with leaf of Viscum coloratum (komar.) Nakai

Herba Wedeliae (蟛蜞菊) Any or whole part of Wedelia chinensis (Osbeck) Merr.

Herba Zephyranthis Candidae (肝風草) Any or whole part of Zephyranthes candida (Lindl.) Herb.

Hirudo (水蛭) Body of Whitmania pigra Whitman, Hirude nipponica Whitman or Whitmania acranulata Whitman

Indigo Naturalis (青黛) Dried powder or mass prepared from the leaf or the stem and leaf of Baphicacanthus cusia (Nees) Bremek., Polygonum tinctorium Ait. or Isatis indigotica Fort.

Lapis Chloriti (青礞石) Black mica schist or a carbonate schist of chlorite mica of metamorphic group

Lapis Micae Aureus (金礞石) Rock schist or black mica schist of metamorphic group

Lasioiphaera seu Calvatia (馬勃) Sporophore of Lasiosphaera fenzlii Reich., Calvatia gigantea (Batsch ex Pers.) Lloyd or Calvatia lilacina (Mont. Et Berk.) Lloyd

Lignum Dalbergiae Odoriferae (降香) Heartwood of trunk and root of Dalbergia odorifera T. Chen

Lignum Pini Nodi (油松節) Node of Pinus tabulaeformis Carr. or Pinus massoniana Lamb.

Limonitum (禹余糧) Mineral of limonite of hydroxides

Medulla Junci (燈心草) Stem pith of Juncus effusus L.

Medulla Stachyuri (小通草) Stem pith of Stachyurus himalaicus Hook. f. et Thoms., Stachyurus chinensis Franch. or Helwingia japonica (Thunb.) Dietr.

Medulla Tetrapanacis (通草) Stem pith of Tetrapanax papyriferus (Hook.)

K. Koch

Moschus (麝香) Secretion of the musk sac of adult male of Moschus berezovskii Flerov,

Moschus sifanicus Przewalski or Moschus moschiferus Linnaeus

Myrrha (沒藥) Oleo-gum-resin from the bark of Commiphora myrrha Engl. (C. molmol Engl.)

Natrii Sulfas (芒硝) Crystal of minerals of sulphates of Glauber's salts

Natrii Sulfas Exsiccatus (玄明粉) Powder obtained from efflorescence of Glauber's salt

Nidus Vespae (蜂房) Honeycomb of Polistes olivaceous (Degeer), Polistes japonicus Saussur or Parapolybia varia Fabricius

Nux Prinsepiae (蕤仁) Ripe kernel of Prinsepia uniflora Batal or Prinsepia uniflora Batal. Var serrata Rehd.

Oleum Linderae (香果脂) Solid fat obtained from the ripe kernel or ripe seed of Lindera communis Hemsl.

Olibanum (乳香) Oleo-gum-resin from the bark of Boswellia carterii Birdw. or the same genus

Omphalia (雷丸) Sclerotium of Omphalia lapidescens Schroet.

Ootheca Mantidis (桑螵蛸) Gee capsule of Tenodera sinensis Saussure, Statilia maculata (Thunberg) or Hierodula patellifera (Serville)

Ophicalcitum (花蕊石) Serpentine marble of metamorphic group

Pericarpium Arecae (大腹皮) Pericarp of Areca catechu L.

Pericarpium Trichosanthis (瓜蔞皮) Pericarp of ripe fruit of Trichosanthes kirilowii Maxim. or Trichosanthes rosthornii Harms

Periostracum Cicadae (蟬蛻) Slough of Cryptotympana pustulata Fabricius dropped off the nymph during emergence

Petiolus Trachycarpi (棕櫚) Petiole of Trachycarpus fortunei H. Wendl.

Pollen Pini (松花粉) Pollen of Pinus massoniana Lamb., Pinus tabulaeformis Carr. or plants of the same genus

Pollen Typhae (蒲黃) Pollen of Typha angustifolia L., Typha orientalis Presl or plants of the same genus

Polyporus (豬苓) Sclerotium of Polyporus umbellatus (Pers.) Fries

Processed Fructus Crotonis (製巴豆) Processed ripe fruit of Croton tiglium L.

Processed Radix Aconiti Kusnezoffii (製草烏) Processed root tuber of Aconitum kusnezoffii Reichb.

Processed Radix Aconiti Lateralis (製附子) Processed daughter root of Aconitum carmichaeli Debx.

Processed Radix Aconiti (製川烏) Processed parent root tuber of Aconitum carmichaeli Debx.

Processed Radix Euphorbiae fischerianae, Processed root of Euphorbia fischeriana Steud.,

Radix Euphorbiae ebracteolatae, or Euphorbia ebracteolata Hayata or Stellera

Radix Stellerae (製狼毒) chamaejasone L.

Processed Radix Kansui (製甘遂) Processed root tuber of Euphorbia kansui T.N. Liou ex T. P. Wang

Processed Resina Garciniae Morellae (製藤黃) Processed gum-resin of Garcinia morella Desv.

Processed Rhizoma Arisaematis (製天南星) Processed tuber of Arisaema erubescens (Wall.) Schott., Arisaema heterophyllum Bl. or Arisaema amurense Maxim.

Processed Rhizoma Pinelliae (製半夏) Processed tuber of Pinellia ternata (Thunb.) Breit.

Processed Rhizoma Typhonii or Radix Processed tuber of Typhonium giganteum Engl.

Aconiti Corean (製白附子 or root tuber of Aconitum coreanum (Levl.)

(禹白附、關白附)) Raipaics

Processed Semen Crotonis (巴豆霜) Processed ripe seed of Croton tiglium L.

Processed Semen Euphorbiae (製千金子) Processed ripe seed of Euphorbia lathyris L.

Processed Semen Hyoscyami (製天仙子) Processed ripe seed of Hyoscyamus niger L.

Processed Semen Strychni (製馬錢子) Processed ripe seed of Strychnos nux-vomica L. or Strychnos pierriana A. W. Hill

Pseudobulbus Cremastrae seu Pleiones Pseudobulb of Cremasstra appendiculata

(山慈菇) (D. Don) Makino, Pleione bulbocodioides

(Franch.) Rolfe or Pleione yunnanensis Rolfe

Pumex (浮石) Non-crystalline mass of Pumice or the skeleton of Costazia aculeata Canu et Bassler or Costazia costazii Audouin

Pyrolusitum (無名異) Mineral of oxides of Pyrolusite

Radix Acanthopanacis Senticosi (刺五加) Root or rhizome of Acanthopanax senticosus (Rupr. et Maxim.) Harms

Radix Acanthopanacis Trifoliati (三葉五加) Root of Acanthopanax trifoliatus (L.) Merr.

Radix Achyranthis Bidentatae (牛膝) Root of Achyranthes bidentata Bl.

Radix Adenophorae (南沙參) Root of Adenophora tetraphylla (Thunb.) Fisch. or Adenophora stricta Miq.

Radix Aerio Fici Microcarpae (榕鬚) Aerial root of Ficus microcarpa L.

Radix Ampelopsis (白蘞) Root tuber of Ampelopsis japonica (Thunb.) Makino

Radix Angelicae Citriodorae (香白芷) Root of Angelica citriodora Hance [Ostericum citriodorum (Hance) Yuan et Shan]

Radix Angelicae Pubescentis (獨活) Root of Angelica pubescens Maxim. f. biserrata Shan et Yuan

Radix Angelicae Sinensis (當歸) Root of Angelica sinensis (Oliv.) Diels

Radix Anisodi Tangutici (山莨菪) Root of Anisodus tanguticus (Maxim.) Pascher

Radix Ardisiae Crenatae (朱砂根) Root of Ardisia crenata Sims

Radix Aristolochiae (青木香) Root of Aristolochia debilis Sieb. et Zucc.

Radix Aristolochiae Fangchi (廣防己) Root of Aristolochia fangchi Y. C. Wu ex L.D. Chou et S. M. Hwang

Radix Aristolochiae Heterophyllae (漢中防己) Root of Aristolochia kaempferi Willd. f. heterophylla (Hemsl.) S. M. Hwang.

Radix Arnebiae or Radix Lithospermi (紫草) Root of Arnebia euchroma (Royle) Johnst, Lithospermum erythrorhizon Sieb. et Zucc. or Arnebia guttata Bunge

Radix Asparagi (天冬) Root tuber of Asparagus cochinchinenesis (Lour.) Merr.

Radix Asteris (紫菀) Root or rhizome of Aster tataricus L.f.

Radix Astragali (黃芪) Root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge.

Radix Aucklandiae (木香) Root of Aucklandia lappa Decne.

Radix Bauhiniae Hupehanae (羊蹄甲) Root of Bauhinia glauca (Wall. ex Benth.) Benth. ssp. hupehana (Craib) T. Chen

Radix Boehmeriae (苧麻根) Root or rhizome of Boehmeria nivea (L.) Gaud.

Radix Bupleuri (柴胡) Root of Bupleurum chinense DC. or Bupleurum scorzonerifolium Willd.

Radix Celastri Orbiculati (南蛇藤根) Root of Celastrus orbiculatus Thunb.

(C. articulatus Thunb.)

Radix Changii (明黨參) Root of Changium smyrnioides Wolff

Radix Chloranthi Serrati (及己) Root of Chloranthus serratus (Thunb.) Roem. et Schult.

Radix Clematidis (威靈仙) Root or Rhizome of Clematis chinensis Osbeck, Clematis hexapetala Pall., Clematia manshurica Rupr.

Radix Clerodendri Philippini (臭茉莉) Root of Clerodendron philippinum Schauer var. simplex Moldenke

Radix Cocculi Trilobi (木防己) Root of Cocculus trilobus (Thunb.) DC.

Radix Codonopsis (黨參) Root of Codonopsis pilosula (Franch.) Nannf., Codonopsis pilosula Nannf. var. modesta (Nannf.) L.T. Shen or Codonopsis tangshen Oliv.

Radix Crotonis Crassifolii (雞骨香) Root of Croton crassifolius Geisel.

Radix Curcumae (鬱金) Root tuber of Curcuma wenyujin Y. H. Chen et C. Ling, Curcuma longa L., Curcuma kwangsiensis S.G. Lee et C. F. Liang or Curcuma phaeocaulis Val.

Radix Cyathulae (川牛膝) Root of Cyathula officinalis Kuan

Radix Cynanchi Atrati (白薇) Root or rhizome of Cynanchum atratum Bge. or Cynanchum versicolor Bge.

Radix Cynanchi Auriculati (白首烏) Root tuber of Cynanchum auriculatum Royle ex Wight

Radix Cynanchi Paniculati (徐長卿) Root or rhizome of Cynanchum paniculatum (Bge.) Kitag.

Radix Cynoglossi Amabilis (接骨草) Root of Cynoglossum amabile Stapf et Drumm.

Radix Dichroae (常山) Root of Dichroa febrifuga Lour.

Radix Dipsaci (續斷) Root of Dipsacus asperoides C. Y. Cheng et T. M. Ai

Radix Echinopsis (禹州漏蘆) Root of Echinops latifolius Tausch or Echinops grijisii Hance

Radix Ephedrae (麻黃根) Root or rhizome of Ephedra sinica Stapf or Ephedra intermediaSchrenket C. A. Mey.

Radix et Rhizoma Nardostachyos (甘松) Root or rhizome of Nardostachys chinensis Batal. or Nardostachys jatamansi DC.

Radix et Rhizoma Rhei (大黃) Root or rhizome of Rheum palmatum L., Rheum tanguticum Maxim. ex Balf or Rheum officinale Baill

Radix et Rhizoma Thalictri (馬尾連) Root or rhizome of Thalictrum foliolosum DC.

Radix et Rhizoma Veratri (藜蘆) Root or rhizome of Veratrum nigrum L. or Veratrum schindleri Loes. f.

Radix Eupatorii Chinensis (廣東土牛膝) Root of Eupatorium chinense L.

Radix Euphorbiae Pekinensis (京大戟) Root of Euphorbia pekinensis Rupr.

Radix Gentianae (龍膽) Root or rhizome of Gentiana manshurica Kitag., Gentiana scabra Bge, Gentiana triflora pall. or Gentiana rigescens Franch

Radix Gentianae Macrophyllae (秦艽) Root of Gentiana macrophylla Pall., Gentiana straminea Maxim, Gentiana crassicaulis Duthie ex Burk. or Gentiana dahurica Fisch.

Radix Ginseng (人參) Root of Panax ginseng C. A. Mey.

Radix Glehniae (北沙參) Root of Glehnia littoralis Fr. Schmidt ex Miq.

Radix Hedysari (紅芪) Root of Hedysarum polybotrys Hand.-Mazz.

Radix Helicteris (山芝麻) Root of Helicteres angustifolia L.

Radix Hemerocallis (萱草根) Root or rhizome of Hemerocallis fulva L., Hemerocallis citrina Baroni or Hemerocallis minor Mill.

Radix Ilicis Asprellae (崗梅根) Root of Ilex asprella (Hook. et Arn.) Champ. ex Benth.

Radix Ilicis Pubescentis (毛冬青) Root of Ilex pubescens Hook. et Arn.

Radix Inulae (土木香) Root of Inula helenium L. or Inula racemosa Hook. f.

Radix Isatidis (板籃根) Root of Isatis indigotica Fort.

Radix Kadsurae Coccineae (黑老虎根) Root of Kadsura coccinea (Lem.) A. C. Smith

Radix Knoxiae (紅大戟) Root tuber of Knoxia valerianoides Thorel et Pitard

Radix Linderae (烏藥) Root tuber of Lindera aggregata (Sims) Kosterm.

Radix Liriopes (山麥冬) Root tuber of Liriope spicata (Thunb.) Lour. var.

Prolifera Y. T. Ma or Liriope muscari (Desne) Baily

Radix Mirabilis (紫茉莉根) Root of Mirabilis jalapa L.

Radix Morindae Officinalis (巴戟天) Root of Morinda officinalis How

Radix Notoginseng (三七) Root of Panax notoginseng (Burk.) F. H. Chen

Radix Ophiopogonis (麥冬) Root tuber of Ophiopogon japonicus (Thunb.) Ker-Gawl.

Radix Oryzae Glutinosae (糯稻根) Rhizome or root of Oryza sativa L. var. glutinosa Matsum.

Radix Paeoniae Alba (白芍) Root of Paeonia lactiflora Pall.

Radix Paeoniae Rubra (赤芍) Root of Paeonia lactiflora Pall. or Paeonia veitchii Lynch

Radix Panacis Quinquefolii (西洋參) Root of Panax quinquefolium L.

Radix Pandani Tectorii (露兜簕) Root of Pandanus tectorius Soland.

Radix Patriniae Heterophyllae or Radix Rhizome or root of Patrinia heterophylla Patriniae Scabrae (墓頭回) Bunge or Patrinia scabra Bunge

Radix Peucedani (前胡) Root of Peucedanum praeruptorum Dunn or peucedanum decursivum Maxim.

Radix Physochlainae (華山參) Root of Physochlaina infundibularis Kuang

Radix Phytolaccae (商陸) Root of Phytolacca acinosa Roxb. or Phytolacca americana L.

Radix Platycodi (桔梗) Root of Platycodon grandiflorum (Jacq.) A. DC.

Radix Plumbaginis Zeylanicae (白花丹) Root of Plumbago zeylanica L.

Radix Polygalae (遠志) Root of Polygala tenuifolia Willd. or Polygala sibirica L.

Radix Polygoni Multiflori (何首烏) Root tuber of Polygonum multiflorum Thunb.

Radix Pseudostellariae (太子參) Root tuber of Pseudostellaria heterophylla (Miq.) Pax ex Pax et Hoffm.

Radix Pterospermi Heterophylli (半楓荷根) Root of Pterospermum heterophyllum Hance

Radix Pteroxygoni Giraldii (紅藥子) Root tuber of Pteroxygonum giraldii Dammer et Diels

Radix Puerariae (葛根) Root of Pueraria lobata (Willd.) Ohwi or Pueraria thomsonii Benth.

Radix Pulsatillae (白頭翁) Root of Pulsatilla chinensis (Bge.) Regel

Radix Ranunculus Ternati (貓爪草) Root tuber of Ranunculus ternatus Thunb.

Radix Rauvolfiae (蘿芙木) Root of Rauvolfia verticillata (Lour.) Baill. or Rauvolfia serpentina (L.) Benth. ex Kurz

Radix Rehmanniae (地黃) Root tuber of Rehmannia glutinosa Libosch.

Radix Rhapontici (漏蘆) Root of Rhaponticum uniflorum (L.) DC.

Radix Rhodomyrti (崗稔根) Root of Rhodomyrtus tomentosa (Ait.) Hassk.

Radix Rubiae (茜草) Root or rhizome of Rubia cordifolia L.

Radix Salviae Miltiorrhizae (丹參) Root or rhizome of Salvia miltiorrhiza Bge.

Radix Sanguisorbae (地榆) Root of Sanguisorba officinalis L. or Sanguisorba officinalis L. var. longifolia (Bert.) Yu et Li

Radix Saposhnikoviae (防風) Root of Saposhnikovia divaricata (Turcz.) Schischk.

Radix Scrophulariae (玄參) Root of Scrophularia ningpoensis Hemsl.

Radix Scutellariae (黃芩) Root of Scutellaria baicalensis Georgi

Radix Semiaquilegiae (天葵子) Root tuber of Semiaquilegia adoxoides (DC.) Makino

Radix seu Caulis Derridis Trifoliatae (魚藤) Root or stem of Derris trifoliata Lour.

Radix Sophorae Flavescentis (苦參) Root of Sophora flavescens Ait.

Radix Stellariae (銀柴胡) Root of Stellaria dichotoma L. var. lanceolata Bge.

Radix Stemonae (百部) Root tuber of Stemona sessilifolia (Miq.) Miq., Stemona japonica (Bl.) Miq. or Stemona tuberosa Lour.

Radix Stephaniae Tetrandrae (防己) Root of Stephania tetrandra S. Moore

Radix Tinosporae (金果欖) Root tuber of Tinospora sagittata (Oliv.) Gagnep. or Tinospora capillipes Gagnep.

Radix Trichosanthis (天花粉) Root of Trichosanthes kirilowii Maxim. or Trichosanthes japonica Regel

Radix Tripterygii Wilfordii (雷公藤) Root of Tripterygium wilfordii Hook. f. Radix Valerianae (纈草) Root or rhizome of Valeriana officinalis L.

Radix Vitis Adstrictae (野葡萄) Root of Vitis adstricta Hance (V. thunbergii Sieb. et Zucc.)

Radix Vladimiriae (川木香) Root of Vladimiria soulei (Franch.) Ling or Vladimiria souliei (Franch.) Ling var. cinerea Ling

Radix Wikstroemae (了哥王) Root of Wikstroemia indica (L.) C. A. Mey.

Radix Zanthoxyli (兩面針) Root of Zanthoxylum nitidum (Roxb.) DC.

Radix Zanthoxyli Avicennae (鷹不泊) Root of Zanthoxylum avicennae (Lam.) DC.

Ramulus Cinnamomi (桂枝) Young branch of Cinnamomum cassia Presl

Ramulus et Folium Mussaendae Stem and leaf of Mussaenda pubescens Ait. f.

Pubescentis (玉葉金花)

Ramulus et Folium Phyllodii Pulchelli Branch and leaf of Phyllodium pulchellum (L.)

(排錢草) Desv. [Desmodium pulchellum (L.) Benth.]

Ramulus et Folium Picrasmae (苦木) Branch or leaf of Picrasma quassioides (D. Don) Benn.

Ramulus Euonymi (鬼箭羽) Corky wing or young branch with corky wing of Euonymus alatus (Thunb.) Sieb.

Ramulus Mori (桑枝) Young branch of Morus alba L.

Ramulus Sambuci Williamsii (接骨木) Stem and branch with leaf of Sambucus williamsii Hance (S. racemosa auct. non L.)

Ramulus Uncariae cum Uncis (鈎藤) Hook-bearing stem and branch of Uncaria rhynchophylla (Miq.) Jacks, Uncaria macrophylla Wall., Uncaria hirsuta Havil., Uncaria sinensis (Oliv.) Havil. or Uncaria sessilifructus Roxb.

Receptaculum Nelumbinis (蓮房) Receptacle of Nelumbo nucifera Gaertn.

Resina Draconis (血竭) Red resin from the fruit of Daemonorops draco Blume (Calamus draco Willd.)

Resina Ferulaen (阿魏) Resin of Ferula sinkiangensis K. M. Shen or Ferula fukanensis K. M. Shen

Resina Liquidamberis (楓香脂) Liquidambar formosana Hance

Resina Toxicodendri (乾漆) Resin of Toxicodendron vernicifluum (Stokes) F. A. Barkl.

Rhizoma Acori Tatarinowii (石菖蒲) Rhizome of Acorus tatarinowii Schott.

Rhizoma Alismatis (澤瀉) Tuber of Alisma orientalis (Sam.) Juzep.

Rhizoma Anemarrhenae (知母) Rhizome of Anemarrhena asphodeloides Bge.

Rhizoma Anemones Altaicae (九節菖蒲) Rhizome of Anemone altaica Fisch. ex C. A. Mey.

Rhizoma Anemones Raddeanae (兩頭尖) Rhizome of Anemone raddeana Regel

Rhizoma Ardisiae Gigantifoliae (走馬胎) Rhizome of Ardisia gigantifolia Stapf

Rhizoma Atractylodis (蒼朮) Rhizome of Atractylodes lancea (Thunb.) DC. or Atractylodes chinensis (DC.) koidz.

Rhizoma Atractylodis Macrocephalae (白朮) Rhizome of Atractylodes macrocephala Koidz.

Rhizoma Belamcandae (射干) Rhizome of Belamcanda chinensis (L.) DC.

Rhizoma Bistortae (拳參) Rhizome of Polygonum bistorta L.

Rhizoma Blechni (烏毛蕨貫眾) Rhizome with petiole of Blechnum orientale L.

Rhizoma Bletillae (白及) Tuber of Bletilla striata (Thunb.) Reichb. f.

Rhizoma Bolbostemmae (土貝母) Tuber of Bolbostemma paniculatum (Maxim.) Franquet

Rhizoma Chuanxiong (川芎) Rhizome of Ligusticum chuanxiong Hort.

Rhizoma Cibotii (狗脊) Rhizome of Cibotium barometz (L.) J. Sm.

Rhizoma Cimicifugae (升麻) Rhizome of Cimicifuga heracleifolia Kom., Cimicifuga dahurica (Turcz.) Maxim. or Cimicifuga foetida L.

Rhizoma Coptidis (黃連) Rhizome of Coptis chinensis Franch., Coptis deltoidea C. Y. Cheng et Hsiao or Coptis teeta Wall.

Rhizoma Corydalis (延胡索) Tuber of Corydalis yanhusuo W. T. Wang

Rhizoma Corydalis Decumbentis (夏天無) Tuber of Corydalis decumbens (Thunb.) Pers.

Rhizoma Curculiginis (仙茅) Rhizome of Curculigo orchioides Gaertn.

Rhizoma Curcumae (莪朮) Rhizome of Curcuma phaeocaulis Valeton, Curcuma kwangsiensis S. G. Lee et C. F. Liang or Curcuma wenyujin Y. H. Chen et C. Ling

Rhizoma Curcumae Longae (薑黃) Rhizome of Curcuma longa L.

Rhizoma Cynanchi Stauntonii (白前) Rhizome or root of Cynanchum stauntonii (Decne.) Schltr. ex Levl. or Cynanchum glaucescens (Decne.) Hang.-Mazz.

Rhizoma Cyperi (香附) Rhizome of Cyperus rotundus L.

Rhizoma Cyrtomii (貫眾) Rhizome with petiole of Cyrtomium fortunei J. Sm.

Rhizoma Dioscoreae Bulbiferae (黃藥子) Tuber of Dioscorea bulbifera L.

Rhizoma Dioscoreae Cirrhosae (薯莨) Tuber of Dioscorea cirrhosa Lour.

Rhizoma Dioscoreae Hypoglaucae (粉萆薢) Rhizome of Dioscorea hypoglauca Palibin

Rhizoma Dioscoreae Nipponicae (穿山龍) Rhizome of Dioscorea nipponica Makino or Dioscorea nipponica Makino var. rosthornii Prain et Burkill

Rhizoma Dioscoreae Septemlobae (綿萆薢) Rhizome of Dioscorea septemloba Thunb. or Dioscorea futschauensis Uline ex R. kunth

Rhizoma Dioscoreae Tokoro (山萆薢) Dioscorea tokoro Makino

Rhizoma Drynariae (骨碎補) Rhizome of Drynaria fortunei (Kunze) J. Sm.

Rhizoma Dryopteris Crassirhizomae Rhizome with petiole of Dryopteris

(綿馬貫眾) crassirhizoma Nakal

Rhizoma et Radix Baphicacanthis Rhizome or root of Baphicacanthus cusia

Cusae (南板藍根) (Nees) Bremek

Rhizoma et Radix Notopterygii (羌活) Rhizome or root of Notopterygium incisum Ting ex H. T. Chang or Notopterygium forbesii Boiss.

Rhizoma Gastrodiae (天麻) Tuber of Gastrodia elata Bl.

Rhizoma Homalomenae (千年健) Rhizome of Homalomena occulta (Lour.) Schott

Rhizoma Ligustici (藁本) Rhizome or root of Ligusticum sinense Oliv. or Ligusticum jeholense Nakai et Kitag.

Rhizoma Matteucciae (莢果蕨貫眾) Rhizome with petiole of Matteuccia struthiopteris (L.) Todaro

Rhizoma Menispermi (北豆根) Rhizome of Menispermum dauricum DC.

Rhizoma Osmundae (紫萁貫眾) Rhizome with petiole of Osmunda japonica Thunb.

Rhizoma Panacis Japonici (竹節參) Rhizome of Panax japonicus C. A. Mey.

Rhizoma Panacis Majoris (珠子參) Rhizome of Panax japonicus C. A. Mey. var. major (Burk.) C. Y. Wu et K. M. Feng or Panax japonicus C. A. Mey var. bipinnatifidus (Seem.) C. Y. Wu. et K. M. Feng

Rhizoma Paridis (重樓) Rhizome of Paris polyphylla Smith var. yunnanensis (Franch.) Hand.- Mazz. or Paris polyphylla Smith var. chinensis (Franch.) Hara

Rhizoma Picrorhizae (胡黃連) Rhizome of Picrorhiza scrophulariiflora Pennell

Rhizoma Polygonati (黃精) Rhizome of Polygonatum kingianum Coll. et Hemsl., Polygonatum sibiricum Red. or Polygonatum cyrtonema Hua

Rhizoma Polygoni Cuspidati (虎杖) Rhizome or root of Polygonum cuspidatum Sieb. et Zucc.

Rhizoma Saururi or Herba Saururi (三白草) Any or whole part of Saururus chinensis (Lour.) Baill.

Rhizoma Smilacis Chinensis (菝葜) Rhizome of Smilax china L. [S. japonica (Kunth) A. Gray]

Rhizoma Smilacis Glabrae (土茯苓) Rhizome of Smilax glabra Roxb.

Rhizoma Sparganii (三棱) Tuber of Sparganium stoloniferum Buch.-Ham

Rhizoma Wenyujin Concisa (片薑黃) Rhizome of Curcuma wenyujin Y. H. Chen et C. Ling

Rhizoma Woodwardiae (狗脊貫眾) Rhizome and petiole of Woodwardia japonica (L.f.) Sm.

Sal Ammoniacus (磠砂) Crystal of Sal-Ammoniac

Scolopendra (蜈蚣) Body of Scolopendra subspinipes mutilans

L. Koch

Scorpio (全蠍) Body of Buthus martensii Karsch

Semen Abri Precatorii (相思子) Seed of Abrus precatorius L.

Semen Abutili (苟麻子) Ripe seed of Abutilon theophrastii Medic.

Semen Aesculi (娑羅子) Ripe seed of Aesculus chinensis Bge., Aesculus chinensis Bge. var. chekingensis (Hu et Fang) Fang or Aesculus wilsonii Rehd.

Semen Allii Tuberosi (韮菜子) Ripe seed of Allium tuberosum Rottl.

Semen Alpiniae Katsumadai (草豆蔻) Almost ripe seed of Alpinia katsumadai Hayata

Semen Arecae (檳榔) Ripe seed of Areca catechu L.

Semen Astragali Complanati (沙苑子) Ripe seed of Astragalus complanatus R. Br.

Semen Cassiae (決明子) Ripe seed of Cassia obtusifolia L. or Cassia tora L.

Semen Cassiae Occidentalis (望江南) Seed of Cassia occidentalis L.

Semen Celosiae (青葙子) Processed ripe seed of Celosia argentea L.

Semen Cuscutae (菟絲子) Ripe seed of Cuscuta chinensis Lam.

Semen Hoveniae (枳椇子) Seed of Hovenia acerba Lindl.

Semen Hydnocarpi (大風子) Seed of Hydnocarpus anthelminticus Pierre ex Laness.

Semen Impatientis (急性子) Seed of Impatiens balsamina L.

Semen Lepidii or Semen Desurainiae (葶藶子) Ripe seed of Lepidium apetalum Willd. or Descurainia sophia (L.) Webb ex prantl

Semen Lini (亞麻子) Ripe seed of Linum usitatissimum L.

Semen Momordicae (木鱉子) Ripe seed of Momordica cochinchinensis (Lour.) Spreng.

Semen Myristicae (肉豆蔻) Ripe kernel of Myristica fragrans Houtt

Semen Nigellae (黑種草子) Ripe seed of Nigella glandulifera Freyn

Semen Oroxyli (木蝴蝶) Ripe seed of Oroxylum indicum (L.) Vent.

Semen Persicae (桃仁) Ripe seed of Prunus persica (L.) Batsch or Prunus davidiana (Carr.) Franch.

Semen Pharbitidis (牽牛子) Ripe seed of Pharbitis nil (L.) Choisy or Pharbitis purpurea (L.) Voigt

Semen Plantaginis (車前子) Ripe seed of Plantago asiatica L. or Plantago depressa Willd.

Semen Platycladi (柏子仁) Ripe kernel of Platycladus orientalis (L.) Franco

Semen Ricini (蓖麻子) Ripe seed of Ricinus communis L.

Semen Sinapis (芥子) Ripe seed of Sinapis alba L. or Brassica juncea (L.) Czern. et Coss.

Semen Sterculiae Lychnophorae (胖大海) Ripe seed of Sterculia Lychnophora Hance

Semen Trichosanthis (瓜蔞子) Ripe seed of Trichosanthes kirilowii Maxim. or Trichosanthes rosthorni Harms

Semen Trigonellae (胡蘆巴) Ripe seed of Trigonella foenum-graecum L.

Semen Vaccariae (王不留行) Ripe seed of Vaccaria segetalis (Neck.) Garcke

Spica Prunellae (夏枯草) Fruit-spike of Prunella vulgaris L.

Spina Gleditsiae (皂角刺) Spine of Gleditsia sinensis Lam.

Spongilla (紫梢花) Colony of Spongilla fragilis (Lecidy)

Spora Lygodii (海金沙) Ripe spore of Lygodium japonicum (Thunb.) Sw.

Stamen Nelumbinis (蓮鬚) Stamen of Nelumbo nucifera Gaertn.

Stigma Croci (西紅花) Stigma of Crocus sativus L.

Styrax (蘇合香) Processed balsam from the trunk of Liquidambar orientalis Mill.

Tabanus (虻蟲) Female body of Atylotus bivittateinus Takahasi

Tremolitum (陽起石) Crystal of Tremolite or Tremolite asbestos

------------------------------

SCHEDULE 3 [s. 24]

Functions of Boards

PART I

Functions of the Chinese Medicine Practitioners Board

The functions of the Chinese Medicine Practitioners Board shall be---

(a) to implement the policy and activities as determined by the Council, and to provide guidance to its committees;

(b) to make recommendations and reports to the Council regarding its activities or the implementation of policies;

(c) to approve or reject applications for registration, limited registration and restoration to the Register;

(d) to set and conduct the Licensing Examination;

(e) to determine the requirements in respect of continuing education in Chinese medicine;

(f) to direct the Registrar to make any alterations to the Register;

(g) to inquire into the conduct of registered Chinese medicine practitioners and applicants for registration as Chinese medicine practitioners and where appropriate, to make such orders as provided for under this Ordinance;

(h) to implement the transitional arrangements for registration of Chinese medicine practitioners including the compilation and maintenance of a list under section 90;

(i) to conduct reviews, where appropriate, against decisions of the committees as provided for under this Ordinance; and

(j) to carry out any other functions assigned to it under the Ordinance or delegated to it by the Council.

PART II

Functions of the Chinese Medicines Board

The functions of the Chinese Medicines Board shall be---

(a) to implement the policy and activities as determined by the Council, and to provide guidance to its committees;

(b) to make recommendations and reports to the Council regarding its activities or the implementation of policies;

(c) to approve or reject applications for registration of proprietary Chinese medicines, variation of registered particulars of proprietary Chinese medicines and to make decision to de-register proprietary Chinese medicines;

(d) to approve or reject applications for licences and renewal of licences in respect of Chinese medicines traders, to determine licensing requirements and to make exemptions as provided for under this Ordinance;

(e) to advise the Council on any amendments to Schedules 1 and 2;

(f) to inquire into the conduct of licensed traders of Chinese medicines and to determine the action to be taken against a licensed trader;

(g) to issue relevant certificates under the Ordinance;

(h) to implement the transitional arrangements for licensing of traders of Chinese medicines and registration of proprietary Chinese medicines;

(i) to handle reviews against decisions of the committees as provided for under this Ordinance; and

(j) to carry out any other functions assigned to it under the Ordinance or delegated to it by the Council.

------------------------------

SCHEDULE 4 [s. 25]

Functions of Committees

PART I

Functions of the Registration Committee

The functions of the Registration Committee shall be---

(a) to make recommendations to the Practitioners Board on the qualifications for registration of Chinese medicine practitioners;

(b) to make recommendations to and assist the Practitioners Board on the procedure, documentation and forms for registration of Chinese medicine practitioners;

(c) to assist the Practitioners Board to consider any application for registration as Chinese medicine practitioners;

(d) to make recommendations to the Practitioners Board on matters relating to the requirements in respect of continuing education in Chinese medicine; and

(e) to carry out any other functions assigned to it under the Ordinance or delegated to it by the Practitioners Board.

PART II

Functions of the Examination Committee

The functions of the Examination Committee shall be---

(a) to make recommendations to the Practitioners Board on the qualifications or training required before a person is considered eligible to undertake the Licensing Examination; and

(b) to carry out any other functions assigned to it under the Ordinance or delegated to it by the Practitioners Board.

PART III

Functions of the Disciplinary Committee of

Chinese Medicine Practitioners

The functions of the Disciplinary Committee of Chinese Medicine Practitioners shall be---

(a) to conduct preliminary investigation into any complaint or information received relating to the professional conduct of any registered Chinese medicine practitioner or applicant for registration which may be inquired into by the Practitioners Board; and to give advice on such matters to the Practitioners Board; and

(b) to make recommendations to the Practitioners Board for the holding of an inquiry.

PART IV

Functions of the Chinese Medicines Committee

The functions of the Chinese Medicines Committee shall be---

(a) to make recommendations to the Medicines Board on any amendments to Schedules 1 and 2;

(b) to make recommendations to the Medicines Board on the registration requirements and standards for registration of proprietary Chinese medicines; and

(c) to carry out any other functions assigned to it under the Ordinance or delegated to it by the Chinese Medicines Board.

PART V

Functions of the Chinese Medicines Traders Committee

The functions of the Chinese Medicines Traders Committee shall be---

(a) to make recommendations to the Medicines Board on the licensing requirements, practising conditions and guidelines in respect of different categories of Chinese medicines traders required to be licensed; and

(b) to carry out any other functions assigned to it under the Ordinance or delegated to it by the Medicines Board.

PART VI

Functions of the Regulatory Committee of

Chinese Medicines Traders

The functions of the Regulatory Committee of Chinese Medicines Traders shall be---

(a) to conduct investigation into any complaint or information received relating to the conduct of a licensed Chinese medicines trader which may be inquired into by the Medicines Board; and where it considers appropriate, to give advice on the matter to the Chinese medicines trader concerned; and

(b) to make recommendations to the Medicines Board as to the appropriate course of action to be taken against the Chinese medicines trader concerned.

SCHEDULE 5 [s. 156]

Delegations

Column 1 Column 2 Column 3

Boards or Functions Delegated boards

committees (Provisions of this Ordinance) or committees

Practitioners Board (a) Chinese Medicine Practitioners Examination

Board to set and conduct Committee

Licensing Examination (section 59)

(b) Eligibility for undertaking Examination

Licensing Examination (section 61) Committee

(c) Certificate of passing Licensing Examination

Examination (section 63) Committee

(d) Service of notice and order of Registration Committee

removal from Register (section 57)

(e) Restoration to Register (section 58) Registration Committee

(f) Certificate of registration Registration Committee

(section 72)

(g) Application for limited registration Registration Committee

(section 84)

(h) Provisions relating to renewal Registration Committee

of limited registration (section 89)

(i) List maintained by Practitioners any committee under

Board (section 90(1), (2), (3)(a), (4) Practitioners Board

and (5) )

(j) Alternative qualifying requirements any committee under

(section 92) Practitioners Board

(k) Exemptions from Licensing any committee under

Examination (section 93) Practitioners Board

(l) Registration assessment (section 94) any committee under

Practitioners Board

(m) Requirement to undertake any committee under

Licensing Examination (section 95) Practitioners Board

Medicines Board (a) Licensing of retailer in Chinese Chinese Medicines

herbal medicines (section 114) Traders Committee

(b) Licensing of wholesale dealers in Chinese Medicines

Chinese herbal medicines Traders Committee

(section 115)

(c) Duration and renewal of licences Chinese Medicines

(section 116) Traders Committee

(d) Licensing of manufacturers Chinese Medicines

(section 132) Traders Committee

(e) Licensing of wholesale dealers in Chinese Medicines

proprietary Chinese medicines Traders Committee

(section 135)

(f) Duration and renewal of licences Chinese Medicines

(section 136) Traders Committee

(g) Registration of proprietary Chinese Medicines

Chinese medicines (section 121) Committee

(h) Duration and renewal of certificate Chinese Medicines

of registration (section 123) Committee

(i) Variation of registered particulars Chinese Medicines

of registered proprietary Chinese Committee

medicines (section 124)

(j) De-registration of proprietary Chinese Medicines

Chinese medicines (section 125) Committee

(k) Clinical trials and medicinal tests Chinese Medicines

(section 129) Committee

(l) Certificate of sale of proprietary Chinese Medicines

Chinese medicines (section 130) Committee

Explanatory Memorandum

The purpose of this Bill is to set up a regulatory framework in respect of Chinese medicine practitioners and traders. The regulatory bodies shall comprise the Chinese Medicine Council ("the Council"), the Chinese Medicine Practitioners Board ("the Practitioners Board") which deals with regulatory matters relating to Chinese medicine practitioners and the Chinese Medicines Board ("the Medicines Board") which deals with regulatory matters relating to Chinese medicines traders. A registration system will be introduced in respect of both Chinese medicine practitioners and proprietary Chinese medicines. A licensing system will be introduced in the trade of Chinese medicines. Retailers and wholesalers in certain Chinese herbal medicines and manufacturers and wholesalers in proprietary Chinese medicines are required to be licensed.

General

2. Clause 1 contains the short title and provides for commencement.

3. Clause 2 defines certain expressions used in the Bill.

Council, Board and Committees

4. Clause 3 establishes the Council.

5. Clauses 4 to 10 set out the constitution and membership of the Council.v 6. Clause 11 sets out the principal functions of the Council.

7. Clause 12 establishes the Practitioners Board and the Medicines Board.

8. Clauses 13 to 23 set out the constitution and membership of the 2 boards.

9. Clause 24 sets out the functions of the 2 boards.v 10. Clause 25 establishes 6 committees under the Practitioners Board and the Medicines Board.

11. Clauses 26 to 28 set out the composition of the Registration Committee, the Examination Committee and the Disciplinary Committee of Chinese Medicine Practitioners under the purview of the Practitioners Board.

12. Clauses 29 to 31 set out the composition of the Chinese Medicines Committee, the Chinese Medicines Traders Committee and the Regulatory Committee of Chinese Medicines Traders under the purview of the Medicines Board.

13. Clause 32 specifies the conduct of meetings for the consideration of complaints or information by the Disciplinary Committee of Chinese Medicine Practitioners and the Regulatory Committee of Chinese Medicines Traders.

14. Clauses 33 to 38 set out the constitution and membership of the 6 committees.

15. Clause 39 empowers the Council to establish other miscellaneous committees.

16. Clauses 40 to 42 set out the membership of the committees to be established under clause 39.

17. Clause 43 provides for the dissolution of a committee established under clause 39.

18. Clause 44 specifies the application of certain provisions to all committees.

19. Clauses 45 to 48 provide for the conduct of meetings generally applicable to the Council, boards and committees.

20. Clause 49 empowers the Council, boards and committees to make standing orders respecting the conduct of meetings.

21. Clause 50 adopts certain provisions in the Interpretation and General Clauses Ordinances (Cap. 1) applicable to the appointments to the Council, boards and committees.

Registration of Chinese Medicine Practitioners

22. Clause 51 provides for the appointment of a Registrar of Chinese Medicine Practitioners.

23. Clauses 52 and 53 require the maintenance and publication of the Register of Chinese Medicine Practitioners.

24. Clauses 54 to 58 empower the Practitioners Board to effect alterations to, remove names from and restore names to the Register.

25. Clause 59 introduces the Licensing Examination.

26. Clause 60 empowers the Practitioners Board to determine the syllabus respecting the Licensing Examination.

27. Clause 61 contains the eligibility criteria for undertaking the Licensing Examination.

28. Clause 62 requires the Practitioners Board to notify candidates of results of the Licensing Examination.

29. Clause 63 provides for the issue of Certificate of passing Licensing Examination.

30. Clause 64 empowers the Practitioners Board to restrict the number of attempts by candidates of the Licensing Examination.

31. Clause 65 provides for examination fees.

32. Clause 66 provides channels for review of decisions relating to the Licensing Examination.

33. Clause 67 contains the qualifications for registration as a registered Chinese medicine practitioner.

34. Clauses 68 and 69 specify the registration procedures.

35. Clauses 70 and 71 set out the circumstances for refusing application for registration.

36. Clauses 72 and 73 deal with the issue of certificates.

37. Clause 74 specifies the titles to be used by registered Chinese medicine practitioners.

38. Clause 75 provides for the recovery of charges and costs by registered and listed Chinese medicine practitioners.

39. Clause 76 requires registered Chinese medicine practitioners to obtain practising certificates before they can practise.

40. Clauses 77 to 80 deal with the issue of practising certificates.

41. Clause 81 provides for the recovery of fees by the Registrar by way of civil debts.

42. Clause 82 empowers the Practitioners Board to determine matters relating to continuing education in Chinese medicine.

43. Clause 83 introduces limited registration which confines Chinese medicine practice to clinical teaching or research.

44. Clauses 84 to 89 deal with the procedural and certification matters relating to limited registration.

45. Clauses 90 and 91 enable existing Chinese medicine practitioners who meet certain requirements to continue their practice within a determined period of time irrespective of whether they apply for inclusion in a list to be maintained by the Practitioners Board (i.e. to be a listed Chinese medicine practitioner).

46. Clause 92 sets out alternative requirements which qualify a Chinese medicine practitioner to obtain registration.

47. Clause 93 enables Chinese medicine practitioners with not less than 15 years of experience or not less than 10 years of experience but with other acceptable qualification to be registered without undertaking the Licensing Examination.

48. Clause 94 enables Chinese medicine practitioners with not less than 10 years of experience or less than 10 years of experience but with acceptable qualification to be registered by way of undergoing a registration assessment.

49. Clause 95 enables Chinese medicine practitioners with less than 10 years of experience to be registered by undertaking the Licensing Examination notwithstanding the eligibility criteria laid down under clause 61.

50. Clause 96 deals with the requirement of notification of assessment results and procedure for review.

51. Clause 97 provides for appeal.

52. Clauses 98 to 104 vest the Practitioners Board with disciplinary powers in respect of Chinese medicine practitioners.

53. Clauses 105 to 108 create offences relating to Chinese medicine practice. Licensing of Chinese Herbal Medicines Traders

54. Clauses 109 and 110 impose restrictions on the sale and possession of Chinese herbal medicines specified in Schedule 1.

55. Clause 111 imposes restriction on the sale of Chinese herbal medicines specified in Schedule 2.

56. Clauses 112 and 113 deal with the application and amendment of Schedules 1 and 2.

57. Clauses 114 and 115 provide for the licensing of retailers and wholesale dealers in Chinese herbal medicines.

58. Clauses 116 and 117 deal with the renewal of licences and the issue of certified copy of licences.

59. Clause 118 provides for a transitional period in which licences are deemed to be granted thus enabling existing Chinese herbal medicines traders to carry on their business during the transitional period.

Registration of Proprietary Chinese Medicines

60. Clause 119 requires proprietary Chinese medicines to be registered.

61. Clauses 120 to 127 deal with the registration procedures, certification and de-registration of proprietary Chinese medicines.

62. Clause 128 provides for a transitional period in which proprietary Chinese medicines are deemed to be registered.

63. Clauses 129 and 130 provide for the issue of certificate for clinical trials and medicinal tests and certificate of sale.

Licensing of Proprietary Chinese

Medicine Traders

64. Clause 131 restricts the manufacture of proprietary Chinese medicines.

65. Clause 132 provides for the licensing of manufacturers of proprietary Chinese medicines.

66. Clause 133 deals with the issue of certificate for manufacturer to facilitate export.

67. Clause 134 restricts the sale of proprietary Chinese medicines.

68. Clauses 135 to 137 provide for the licensing of wholesale dealer in proprietary Chinese medicines and the issue of relevant licences.

69. Clause 138 provides for a transitional period in which licences for manufacturers and wholesale dealers in proprietary Chinese medicines are deemed to be granted.

Miscellaneous

70. Clause 139 empowers the Medicines Board to suspend, revoke or vary the licences issued in respect of Chinese medicines traders.

71. Clauses 140 and 141 provide for review and appeal against decisions of the Medicines Board.

72. Clause 142 requires Chinese herbal medicines to be labelled.

73. Clauses 143 and 144 require proprietary Chinese medicines to be labelled and provided with package inserts.

74. Clause 145 requires licence holders to notify the Medicines Board of any change of address of premises.

75. Clauses 146 to 153 deal with matters relating to the enforcement of the Ordinance.

76. Clause 154 creates offences and provides for penalties.

77. Clause 155 provides for defence for certain offences.

78. Clause 156 provides for delegation of functions and powers.

79. Clause 157 provides for exemptions.

80. Clause 158 deals with service of notices and orders.

81. Clause 159 makes fees paid under the Ordinance not refundable.

82. Clause 160 empowers the Chief Executive in Council, the Secretary of Health and Welfare and the Council (with the approval of the Secretary of Health and Welfare) to make regulations.

83. Schedules 1 and 2 set out the Chinese herbal medicines to be regulated.

84. Schedules 3 and 4 set out the respective functions of the Practitioners Board, the Medicines Board and 6 committees under the boards.

85. Schedule 5 sets out the delegation of various functions from the Practitioners Board and Medicines Board to their respective committees.