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