Pharmacy Law

Overview & Pharmacy and Poisons Board

Lecture 1

Kenneth Lo, DH Pharmacist

Risk Management and Operations Division, Operation Unit
MPharm, LLB, MPH
Pharmacist
 Healthcare Role
 First line and Second line support
 Expertise in drugs, pharmaceutics, pharmaceutical care,
consultation etc.
 Name will be entered on the register
 A professional

Uphold a standard and bound by law

Outline
 Overview of Drug Regulation & Pharmacy and Poisons Board
 Registration of Pharmacist
 Disciplinary Committee
 Registration of Pharmaceutical Products
 Clinical Trials
 Labelling
 Sales and Supply of Dangerous Drugs
 Import and Export of Pharmaceutical Products and Dangerous Drugs
Today

 Overview of Drug Regulation

 Composition and function of Pharmacy and Poisons Board
 Committees and Appeal Tribunal
 Registration of Pharmacist
 Disciplinary Committee
 Regulatory Authorities
Drug
PPB Others
Office

Administer

Drug Regulation

Legislation
Relevant
Composition legislation
Sanctions
Offence Licensee
COP/COC Guidance Contravention specific
Decision by RA
Legislations
 Cap. 138 Pharmacy and Poisons Ordinance and Regulations
 Cap. 137 Antibiotics Ordinance and Regulations
 Cap. 134 Dangerous Drugs Ordinance and Regulations
 Cap. 231 Undesirable Medical Advertisements Ordinance
 Cap. 60A Import and Export Regulations
 Cap. 132 Public Health and Municipal Services Ordinance and
Regulations
Composition of Legislation
 Ordinance
 The primary legislature in Hong Kong
 Enacted upon the advice and consent of the Legislative Council
 Subsidiary Legislation
 Law-making powers are delegated to government bodies
 Regulations, rules, order, notice
 Usually supplements ordinances
 Provides more detailed descriptions of what one may or may not do
Pharmacy and Poisons Ordinance
Purpose: Consolidate and amend the law relating to pharmacy,
pharmaceutical products and poisons
 Pharmacy and Poisons Regulations (Cap. 138A)
 Course of Training, Study and Examination for Applicants for
Registration as Pharmacists Regulations (Cap. 138C)
 Pharmacy and Poisons (Pharmacy and Poisons Appeal Tribunal)
Regulations (Cap. 138D)
 Pharmacists (Disciplinary Procedure) Regulations (Cap. 138E)
Antibiotics Ordinance (Cap. 137)
To control the sale and supply of certain antibiotics substances
 Antibiotics Regulations (Cap. 137A)

Dangerous Drugs Ordinance (Cap. 134)

To amend and consolidate the law relating to dangerous drugs
 Dangerous Drugs Regulations (Cap. 134A)

Undesirable Medical Advertisements

Ordinance(Cap. 231)
 To restrict certain advertisements relating to medical and health claims and matters
Import and Export Ordinance(Cap. 60)
Regulation and control of articles import into and export from Hong Kong
 Import and Export (General) Regulations (Cap. 60A)

Public Health and Municipal Services Ordinance

(Cap. 132)
Regulation of public health and municipal services
 Food and Drugs (Composition and Labelling) Regulation (Cap. 132W)

Trade Descriptions Ordinance (Cap. 362)

Offences under Cap.132 Public Health
and Municipal Services Ordinance
Cap.132 possible offences
 Section 51(1) – Selling drug not of the nature, substance or quality demanded by the
purchaser
 Section 54(1) – Selling or offer/ expose/ possession for sale drug intended for use by man
but unfit for that purpose
 Section 61(1) – Selling/ Expose for sale a drug with a label which falsely describes the drug
- Selling/ Expose for sale a drug with a label which is calculated to mislead
its nature, substance or quality
Offences under Cap. 362 Trade Descriptions
Ordinance
Cap. 362 possible offences
 Section 7(1) and 7A(1) –
1) Applying false trade description to any goods/ service supplied or offered to
be supplied.
2) Supplying or offering to supply any goods/ service to which a false trade
description is applied.
3) Possession for sale or for any purpose of trade or manufacture any goods to
which a false trade description is applied.
 Section 9(1) –
1) Forging a trademark
2) Applying falsely to any goods any trademark or any mark so nearly resembling
a trademark as to be calculated to deceive
Code of Practice and Conduct
 Section 4B of Cap.138
The Board may issue codes of conduct and codes of practice that it considers suitable
for providing practical guidance
Decision by Regulatory Authorities
Administrative
Guidance
Offences, Penalties and Sanctions (Examples)

 Cap. 138 Pharmacy and Poisons Ordinance and Regulations

 Section 33(1) – Any person who contravenes section 21, 23,26,27,28 or 28A shall be
guilty of an offence
 Section 34 – Any person who is guilty of an offence under this Ordinance shall, unless
a penalty is otherwise expressly provided, be liable on conviction to a fine at Level 6
and to imprisonment for 2 years
 Regulation 26(5) Cap. 138A – In any of the circumstances specified in paragraph (5A),
the Committee may –
(a) Revoke a wholesale dealer licence or suspend it for a period it thinks fit;
(b) Issue a warning letter to the licensed wholesale dealer; or
(c) Vary a condition of the licence imposed under paragraph (3)
Offences, Penalties and Sanctions (Examples)

 Cap. 137 Antibiotics Ordinance and Regulations

 Section 4(1) & 10(1) – Selling Substance to which Antibiotics Ordinance Cap. 137
applies without the authority of a prescription
 Section 7(2) & (6) – Failing to keep proper record of antibiotics
 Cap. 134 Dangerous Drugs Ordinance and Regulations
 Section 4(1)(a) & 4(3) – Trafficking in dangerous drug
 Section 23(4) & (6) – Failing to keep dangerous drug in a locked receptacle
 Reg.5(1)(a) & 5(7) – Failing to keep register or records of a dangerous drug
Regulatory Authorities

 Pharmacy and Poisons Board and its Committees

https://www.ppbhk.org.hk/eng/index.html
 Drug Office, Department of Health
- Law enforcement agency
- Executive arm of the Board and its Committees
 Director of Health
 Customs and Excise Department
 Police Force
Pharmacy and Poisons Board
Establishment
 Established under Section 3(1) of Cap.138
 Shall be a board to carry out functions in
accordance with the provisions of Cap.138
and its subsidiary legislation
 https://www.ppbhk.org.hk/eng/index.html
Drug Office of Department of Health

 Law enforcement agency

 Executive arm for Pharmacy and Poisons Board
 Regulate the licensing of manufacturer,
wholesaler, Listed Seller of Poisons and
Authorised Seller of Poisons
 Market Surveillance
 Drug Evaluation and Import/Export Control
 Investigation
Annual Report of PPB
https://www.ppbhk.org.hk/eng/report/
pharmacy_poisons_board_of_hong_kong
_2020report.pdf
 Pharmacy and Poison Board
Composition

Functions
Pharm Traders PP

Powers

Executive Committees (7) Forms Regulations COP/COC

Pharm x 2, LSP, WDL, ML, Reg + CT, Poisons Disciplinary committee

Decisions

Pharmacy and Poison Appeal Tribunal

Procedures
Appeals Composition Notice of appeal  hearing  decision

Court of First Instance

Composition
 Director of Health (Chairman)
 Government Chemist
 Assistant Director of Health (Drug Office)
 1 Medical Officer (Appointed by CE)
 1 Legal Advisor (Legally qualified and appointed by CE)
 1 Full-time teaching pharmacologist (HKU) (Appointed by CE)
 1 Full-time teaching pharmacologist (CUHK) (Appointed by CE)
 3 Registered Pharmacists (Nominated by PSHK) (Appointed by CE)
 1 Registered Medical Practitioner (HKMA) (Appointed by CE)
 1 Secretary (Appointed by CE)

P.S. Section 3(3) Cap.138

The members of the Board appointed by the CE shall hold office for a period of 3 years from the date of
their appointment
Functions
Section 2 of the Annual Report
The Board is established under section 3 of the Pharmacy and Poisons Ordinance to carry out the following functions in
accordance with the provisions of the same Ordinance and its subsidiary legislation:

 Pharmacist
- Registration of pharmacists
- Discipline of pharmacists
 Traders (Retailers ASP / LSP, WDL & ML)
- Licensing (Inspections & Test purchase)
- Regulatory control
 Pharmaceutical products
 Sale  Dispensing
 Purchase  Registration
 Compounding  Classification
Power to establish Executive Committees
Section 4A(1), Cap. 138 (Power of Board to establish executive committees)
The Board may establish such number of executive committees as it may deem fit for the purpose of performing -

 Perform functions of – registration, licensing or certification:

 Persons
 Poisons
 Pharmaceutical products
 Persons entitled to retail sale of Part 2 poisons – e.g. LSP

Section 4A(2), Cap. 138 (Power of Board to establish executive committees)

The establishment of a committee shall be -

 Notified by the Board in the Gazette

 Specify the purpose of such committee
Composition & Procedures of Executive Committees
Section 4A(2) and 4A(4), Cap. 138 (Power of Board to establish executive committees)

Composition
 Appointed by the Board
 Chairman – Board member
 Members – Board member or not
 Term
 Determined by the Board
 Procedures
 Determined by the Board
Existing Executive Committee
1. Examination Committee
Pharmacist
2. Postgraduate Pharmacy Training and Development Committee
3. Pharmacy and Poisons (Listed Sellers of Poisons) Committee
4. Pharmacy and Poisons (Wholesale Licences) Committee Traders
5. Pharmacy and Poisons (Manufacturers Licensing) Committee
6. Pharmacy and Poisons (Registration of Pharmaceutical
Products and Substances: Certification of Clinical Product/
Trial/Medicinal Test) Committee substance

7. Poisons Committee
1. Examination Committee
Section 8(3), Cap. 138 (Qualifications for registration as pharmacists)

Purpose
 Registration of Pharmacists
 Conducting examinations
(a) advise the Board on matters regarding the registration of pharmacists and the training requirements and
the examinations for registration;
(b) draw up and review the syllabuses of the registration examinations;
(c) appoint panels to assist in setting question papers and marking answer scripts for the registration
examinations;
(d) oversee the setting and marking of examination papers;
(e) prepare and conduct the registration examinations;
(f) review the results of registration examinations and make recommendations regarding applicants’
eligibility for registration to the Board for consideration;
(g) consider complaints and unusual circumstances arising from applications for registration or examinations,
and make recommendations to the Board for consideration; and
(h) keep under review the standard of the registration examinations.
2. Postgraduate Pharmacy Training and
Development Committee
Purpose
 Registration of Pharmacists
 Assisting aspects of pharmacy internship training
(a) assist the Board in the registration of internship training institutions and preceptors;
(b) assist the Board in drawing up the criteria for the approval of the content of the preceptor’s quarterly
appraisal forms and the intern’s annual assessment forms proposed by the different training institutions
and in implementing the criteria, and to establish sub-committees for these purposes where necessary;
(c) assist the Board in drawing up the criteria for the evaluation of the preceptor’s quarterly appraisals and
the intern’s annual assessments and in implementing the criteria, and to establish sub-committees for
these purposes where necessary;
(d) advise the Board on matters pertaining to pharmacy internship training;
(e) liaise with internship training institutions and with preceptors on matters pertaining to internship
training as necessary; and
(f) carry out such other functions connected with internship training as may be permitted or assigned to the
Committee by the Board
(g) Advise the Board on matters pertaining to the continuous professional development (“CPD”)
3. Pharmacy and Poisons
(Listed Sellers of Poisons) Committee
Regulation 24A, Cap. 138A (Applications to be entered on list under section 25)

Purpose
 Consider and approve, may grant or even refuse
 Applications of LSP

 The Pharmacy and Poisons (Listed Sellers of Poisons) Committee is established to

consider and approve applications for listed sellers of poisons under regulation 24A of
the Pharmacy and Poisons Regulations (Cap.138A, Laws of Hong Kong).
4. Pharmacy and Poisons
(Wholesale Licences) Committee
Regulation 26, Cap. 138A (Pharmacy and Poisons (Wholesale Licences) Committee)

Purpose
 Wholesale dealer
 Issue licence
The Committee may -
 Revoke or suspend licence
 Issue a warning letter
 Vary condition(s) of the licence

(a) to consider and approve applications for wholesale dealer licence, subject to any conditions it
thinks fit to impose; and
(b) to revoke a wholesale dealer licence, suspend a wholesale dealer licence for a specified period,
issue warning letter(s) to the licensed wholesale dealer or vary a condition of the wholesale
dealer licence in the circumstances specified in Regulation 26 of the Pharmacy and Poisons
Regulations.
5. Pharmacy and Poisons
(Manufacturers Licensing) Committee
Regulation 29, Cap. 138A (Licensing of manufacturers)

Purpose
 Manufacturer
 Issue licence
The Committee may -
 Revoke or suspend licence
 Issue a warning letter
 Vary condition(s) of the licence
 Consider and approve / cancel / suspend authorized person
6. Pharmacy and Poisons
(Registration of Pharmaceutical Products and Substances:
Certification of Clinical Trial/Medicinal Test) Committee
Regulation 36, Cap. 138A(Registration of pharmaceutical products and substances)

Purpose
PP Registration
 Consider application and issue certificates
 Vary a condition
 Deregister/ suspend / warning letter
 Consider change of particulars
Clinical trial & Medicinal Test
 Consider application and issue clinical trial or medicinal test certificate
 Cancel clinical trial or medicinal test certificate/ suspend/ issue warning letter
6. Pharmacy and Poisons (Registration of Pharmaceutical
Products and Substances: Certification of Clinical
Trial/Medicinal Test) Committee
(a) consider new or renewal applications for registration of pharmaceutical products or
substances, and issue registration certificates subject to any conditions it thinks fit to
impose;
(b) deregister a pharmaceutical product or substance, suspend the registration of a
pharmaceutical product or substance for a specified period, issue warning letter(s) to the
holder of a registration certificate or vary a condition of the registration of pharmaceutical
products or substances;
(c) consider applications for approval to change any of the registrable particulars of a
pharmaceutical product or substance;
(d) consider applications for conducting a clinical trial on human beings or a medicinal test on
animals, and issue a clinical trial certificate or medicinal test certificate, subject to any
conditions it thinks fit to impose; and
(e) cancel a clinical trial certificate or medicinal test certificate, suspend a clinical trial
certificate or medicinal test certificate for a specified period, issue warning letter(s) to the
holder of the certificate or vary a condition of the certificate.
7. Poisons Committee
Section 31, Cap. 138 (Poisons Committee)

Purpose
 Advising the Board on the classification of poisons and pharmaceutical
products
 Review of the classification of pharmaceutical products regulated under
the Pharmacy and Poisons Regulations

Poisons Committee consist of –

 Registered medical practitioner appointed under section 3(2)(h); and
 5 other members of the Board appointed by the Board
Power to appoint a Disciplinary Committee
Section 15, Cap. 138 (Appointment of Disciplinary Committee)
 The Board may appoint a Disciplinary Committee to inquire into conduct of
 Registered pharmacist/ employee
 ASP/ employee/ officer partner
 When:
 A complaint is received
 Appears to the Board that a condition under section 13 has been contravened [registration of
any premises of an authorized seller of poisons ]

 Any of the persons above is convicted of:

Pharmacy and Poisons Ordinance Cap.138
Dangerous Drugs Ordinance Cap. 134
Antibiotics Ordinance Cap. 137
Undesirable Medical Advertisements Ordinance Cap. 231
Section 52, 54 or 61 of Public Health and Municipal Services Ordinance Cap. 132
Section 7, 7A or 9 of the Trade Description Ordinance Cap. 362
Power to issue Codes of Conduct and Codes of Practice
Section 4B(1), Cap. 138 (Codes of conduct and codes of practice)
 Issue Codes of Conduct and Codes of Practice for providing practical guidance
Section 2, Cap. 138 (Interpretation)
 Code of conduct (《行為守則》)
 Code of practice (《執業守則》)
Section 4B(8) , Cap. 138 (Codes of conduct and codes of practice)
 Different Codes of conduct or codes of practice may be issued for different purposes
Section 4B(2) , Cap. 138 (Codes of conduct and codes of practice)
a) Prepared by the Board or other body or authority
b) Apply, incorporate or refer to formulated or published document in force at the time or
as amended, formulated or published from time to time
Power to issue Codes of Conduct and Codes of Practice
Section 4B(4), Cap. 138 (Codes of conduct and codes of practice)
 The Board may from time to time revise the whole or any part of COC or COP
Section 4B, Cap. 138 (Codes of conduct and codes of practice)
 If a COC or COP is issued or revised, the Board must by notice published in Gazette –
identify the code and specific taking effect date
Section 4B(6) , Cap. 138 (Codes of conduct and codes of practice)
 The Board must make a copy of every COC and COP available for inspection by the public
free of charge –
a) At the office of the Secretary during office hours; and
b) In any other manner the Board thinks fit.
Power to make regulations
Section 29 and 29(1), Cap. 138 (Power to make regulations)

 Subject to the approval of the Legislative Council, the Board may

make regulations
 The courses of training and an examination for registration as pharmacists
 Prescribing or disposal of the fees in issuing certificates
 Prescribing the procedure in inquiries held by the Disciplinary Committee
 Regulating and determination of applications under section 13 in respect of
registration of premises and providing for appeals
 Prescribing the form of logo under Section 13A
 Dispensing with or relaxing with respect to poisons any of the provisions of
this Ordinance relating to the sale of poisons
Power to make regulations
Section 29 and 29(1), Cap. 138 (Power to make regulations)

 Exempt any article or substance from the provisions of this Ordinance

 Providing for the licensing of wholesale dealers and manufacturers in poisons or
pharmaceutical products
 Can revoke, suspend, vary the condition or issue warning letters to Wholesale dealers or
Manufacturers
 Control the standard of persons to be employed or engaged in manufacturing
 Regulate and control the sale of poisons including Part 2 Poisons by Listed sellers of
poisons
 Providing the registration and renewal of registration of any person referred before –
cancellation, suspension or variation of conditions of the registration
 Regulate the type of containers in which various poisons or pp may be stored or sold and
also the labelling of containers
 Regulate the storage and transport of medicines and poisons
Power to make regulations
Section 29(1) and 29(1B), Cap. 138 (Power to make regulations)
 Regulation and controlling of the selling, purchasing, compounding and dispensing of
poisons and medicines
 Registration and renewal of pharmaceutical products manufactured in or imported into
Hong Kong
 The control of the conduct of clinical trials on human beings and medicinal tests on
animals
 Prescribing a list of poisons to be called the Poisons List
 Providing for the specification of forms for the purposes of the regulations

 The Board may, subject to the approval of the Secretary for Food and Health and s31,
amend –
a) The Poisons List: or
b) Any list in a regulation made under subsection (1), of any substances or articles –
i) to which a provision in this Ordinance applies; or
ii) which are exempt from any such provision.
Power to make regulations
Power to make regulations
Section 29(2), Cap. 138
(Power to make regulations)

 A contravention shall be an offence and

may prescribe penalties for such offence
not exceeding the penalties specified in
section 34 - a fine at level 6 ($100,000)
and to imprisonment for 2 years.
Power to specify forms
Section 29A(1) and 29A(2), Cap. 138 (Power of Board to specify forms)

 The Board may specify forms to be used for any provision of this Ordinance
 If a form is specified under this section, the Board must take copies of the
form available for inspection by the public free of charge –
a) At the office of the Secretary during office hours; and
b) In any other manner the Board thinks fit
Power to specify forms
Pharmacy and Poisons Appeal Tribunal
When there is an appeal against the
decision of the Board and the Committee
Pharmacy and Poisons Appeal Tribunal
Section 30(1), Cap. 138 (Pharmacy and Poisons Appeal Tribunal)

 There shall be a Pharmacy and Poisons Appeal Tribunal with jurisdiction to hear
and determine:
 Any appeal against a decision of the Board regarding registration of premises ASP
 Any appeal against a decision of the Board regarding LSP or any regulations made
under section 29
 Any appeal against a decision of the committee made in regulations under
section 29 or under section 4A(8)
Composition of Pharmacy and Poisons Appeal
Tribunal
Section 30(2), Cap. 138 (Pharmacy and Poisons Appeal Tribunal)

Members:
 Appointed by the Chief Executive –
 Legal qualified person [Chairman]
 Registered medical practitioner
 Registered pharmacist
 Person qualified in pharmacology
 Nominated by the Director of Health
 Pharmacists’ associations
 Pharmaceutical industry
 Retail pharmaceutical trade
Composition of Pharmacy and Poisons Appeal
Tribunal
Section 30(2), Cap. 138 (Pharmacy and Poisons Appeal Tribunal)

Members:
 Appointed by the Chief Executive –
 Legal qualified person [Chairman]
 Registered medical practitioner
 Registered pharmacist
 Person qualified in pharmacology
 Nominated by the Director of Health
 Pharmacists’ associations The members representing are
nominated by the Director of Health
 Pharmaceutical industry from a panel nominated by them and
 Retail pharmaceutical trade appointed by the Chief Executive
Composition of Pharmacy and Poisons Appeal
Tribunal
Section 30(6) and 30(7), Cap. 138 (Pharmacy and Poisons Appeal Tribunal)

Members:  If the chairman is unable to attend the

hearing, the Director may designate to
 Appointed by the Chief Executive – act as Chairman
 Legal qualified person [Chairman]
 Registered medical practitioner  The tribunal may act notwithstanding
 Registered pharmacist any vacancy in its membership and
shall be duly constituted if it consist
 Person qualified in pharmacology
the Chairman and not less than 2 other
 Nominated by the Director of Health members sitting together
 Pharmacists’ associations
 Pharmaceutical industry
 Retail pharmaceutical trade
Term
Section 30(4) and 30(5), Cap. 138 (Pharmacy and Poisons Appeal Tribunal)
 Members appointed by Chief Executive under subsection (2)(a) shall hold
office for a period of not exceeding 3 years
 Members that are nominated by the Director of Health shall hold office for a
period of nominated to act

Section 30(7A), Cap. 138 (Pharmacy and Poisons Appeal Tribunal)

 Where—
(a) a member resigns, or his term of office expires, and he is not immediately
reappointed to be or renominated to act as a member of the Tribunal; and
(b) at the time of the member’s resignation or expiry of his term of office the
hearing of an appeal under this section is continuing,
then for the purpose of hearing and determining the appeal—
(i) the member shall continue to hold office; and
(ii) the appointment or nomination of any person to the office previously
held by the member shall take effect subject to this subsection.
Appeal Procedures
Section 30(10), Cap. 138 (Pharmacy and Poisons Appeal Tribunal)

 The Secretary for Food and Health may make

regulations
 Regulating the appeals and the practice and
procedure of the Tribunal
 Prescribing fees in respect of such appeals
Notice of Appeal
Regulation 3(1) and 3(2), Cap. 138D
(Notice of appeal)
 Any persons who appeals to the Tribunal
shall give notice in writing stating the
grounds of the appeal and related
matters intends to rely in support of the
appeal
 He shall send such notice to the
Chairman and a copy of such to the
Director of Health
 Such appeal shall be given not later
than 28 days after the date of the
decision
Hearing
Regulation 6, Cap. 138D (Hearing to be open)
 The place where the Tribunal sits shall be open to the public
 The Chairman may prevent the entry or order the removal of a person who could
interrupt or disturb the proceedings
Regulation 7(1), Cap. 138D (Appearance of parties at appeal)
 Could be heard in person or by counsel (Barrister or a solicitor) or any other person
who is allowed by leave of the Chairman to appear on behalf of any parties
Regulation 7(2), Cap. 138D (Appearance of parties at appeal)
 If the appellant fails to appear, the Tribunal may adjourn the hearing to a later date
or dismiss the appeal
Procedures of Hearing
Regulation 8, Cap. 138D (Procedure at hearing)
 The appellant shall present his case first and followed by the Director
Regulation 9(1), Cap. 138D (Evidence)
 The partiers may call witnesses to give evidence and the Tribunal may hear
such evidence on oath
Regulation 10, Cap. 138D (Examination of witnesses)
 Any person who gives evidence before the Tribunal may be cross-examined
Section 30(8), Cap. 138D (Pharmacy and Poisons Appeal Tribunal)
 The Tribunal may summon any person to attend and give evidence or to
produce any document relating to any appeal
Procedures of Hearing
Regulation 9(3), Cap. 138D (Evidence)
 The Chairman may accept evidence by affidavit but in such event the
Chairman may direct that person to attend for examination
Regulation 12, Cap. 138D (View of premises etc.)
 If the Chairman is satisfied that it is desirable for the purpose of an appeal,
the Tribunal may visit any premises or place in order to determine any
question arising on the hearing
Decision
Section 30(9), Cap. 138 (Pharmacy and Poisons Appeal Tribunal)
 The tribunal may dismiss or allow wholly or in part of the appeal with reasons
for its decision
Regulation 13(2), Cap. 138D (Decision)
 In the event of a difference between the members, decision will be taken
from majority of members. If the members are equally divided, the appeal
shall be dismissed
Regulation 13(1), Cap. 138D (Decision)
 The decision shall be given in writing with a brief statement of reasons and
shall be signed by the Chairman
Regulation 13(3), Cap. 138D (Decision)
 The decision shall be notified to the parties and the appellant shall, upon
application, be furnished with a copy
Appeal
Section 30A, Cap. 138 (Right of appeal to Court of First Instance)

 For appeals that is dismissed or allowed in part only by the Tribunal under
section 30, may appeal to the Court of First Instance not later than 28 days
after the decision
Registration of Pharmacist
 Registration of Pharmacist
Restriction on use of certain titles

Requirements (Local / non-local)

Qualification Examination Training

Code of Conduct

Contravention
Register Correction
Amend particulars Disciplinary Committee
Entry Exercise of power
Deletion

Certificates
Registration Good Standing Practising Misuse
Relevant Legislative Provisions
 Part 3, Cap. 138 (Pharmacists: Requirements for Registration and Practising Certificate)
 Section 5 (The register of pharmacists)
 Section 6 (Evidence of registration)
 Section 7 (Correction of register)
 Section 8 (Qualification for registration as pharmacists)
 Section 9 (Certificate of registration as a pharmacist)
 Section 9A (Certificate of good standing)
 Section 10 (Misuse of certificate of registration)
 Section 10A (Registered pharmacist not to practice without practising certificate
 Section 10B (Recovery of practising fees)
 Section 20 (Restriction on use of certain titles, etc.), Cap. 138
Restriction on use of certain titles
Section 20(1), Cap. 138 (Restriction on use of certain titles, etc.)

 Other than registered pharmacist or ASP, take or uses title, emblem or description
• In connection with
• retail sale of poisons OR
• Dispensing, compounding or manufacturing of poisons or PP
• Might reasonably be taken to suggest
• He or person employed by him is a registered pharmacist OR
• He is an ASP OR
• He or person employed by him possess academic qualification other than he in fact
possesses
Restriction on use of certain titles
Section 20(2), Cap. 138 (Restriction on use of certain titles, etc.)
 The terms:

Chemist Druggist
Pharmacist Pharmaceutical chemist
Pharmaceutist Member of the Pharmaceutical Society
化學師 藥師
藥劑師 藥劑化學師
藥劑學家 藥學會會員

Any combination of such terms in any language shall be deemed to be calculated to suggest
that the person having control is a registered pharmacist or is employed in that business
Restriction on use of certain titles
Section 20(3), Cap. 138 (Restriction on use of certain titles, etc.)

 The terms:

Pharmacy Dispensary

Drug-store 藥房
Used in connection with premises shall be deemed to be calculated to suggest
that such premises are ASP and under control of a registered pharmacist
So what is “Registered”
 Section 2, Cap. 138 (Interpretation)
In relation to a pharmacist, a person whose name has been entered on the
register of pharmacist under section 5 – the register of pharmacists
Registration Requirements
Section 8(1), Cap. 138 (Qualifications for registration as pharmacists)
 Subject to the provisions of this Ordinance, there may be registered as a pharmacist
any person who—
(a) holds a diploma in pharmacy of the University of Hong Kong;
(b) is duly registered as a pharmaceutical chemist or chemist and druggist with the
Pharmaceutical Society of Great Britain;
(c) holds a certificate of a Commonwealth pharmaceutical institution which has entered into
an agreement for reciprocity of registration with the Pharmaceutical Society of Great
Britain;
(d) has successfully completed a course of training and study and who has passed any
examinations thereon that may have been prescribed by the Board;
(e) holds any diploma or certificate, other than a certificate to which paragraph (c) refers,
and who has satisfied the Board by examination or otherwise that he has the skill and
experience in pharmacy equivalent to that possessed by a person to whom paragraphs (a)
to (d) relate.
Registration Requirements
Section 8(2), Cap. 138 (Qualifications for registration as pharmacists)

 The Board may require any applicant to pass

examination as it may determine or to undergo
such period of training as the Board may specify

 https://www.ppbhk.org.hk/eng/files/explanatory
_notes.pdf
Qualification Requirements

2.1 An applicant must meet one of the following two criteria:

 Local
Pharmacy degree (Full time) awarded by HKU or CUHK
 Non Local
Tertiary education in pharmacy not less than 3 full time academic years AND
Registered or professionally qualified to be registered in the country of that education
Examination Requirements
 Local
May be exempted from the requirement of passing the Board’s examinations
 Non-local
Must pass all of the Board’s written examinations:
1. Pharmacy Legislation in Hong Kong
2. Pharmacy Practice
3. Pharmacology
Training
• Local
• Board-approved training in Hong Kong for appropriate period determined by the
Board
• Normally 1 year including not more than 4 weeks holiday
• Non-local
• Relevant pre-registration training and/or post-registration experience for
aggregated period not less than 1 year of which
• Involving direct patient care service (for aggregate period of not less than 6
months)
Fall Short
• An applicant who has had less than one year’s training and experience or less than 6
months’ training and experience in settings involving direct patient care services,
he/she will be required to undergo Board-approved training for a specified period in
Hong Kong or elsewhere
Register of Pharmacists
Section 5(1), Cap. 138 (The register of pharmacists)

 The Secretary to enter in a register the names and addresses of all persons qualified to be
registered as pharmacists
Section 5(2), Cap. 138 (The register of pharmacists)
 The register of pharmacists must be available for inspection by the public free of charge
Section 5(3), Cap. 138 (The register of pharmacists)
 Copy of the register to be published in the Gazette once every 12 months
Correction of Register
Section 7(1), Cap. 138 (Correction of register)
 The Secretary may amend the register as to the address or any other particulars if such
amendment is necessary for preserving accuracy
Section 7(2), Cap. 138 (Correction of register)
 The Secretary shall make such entries in the register of pharmacists as the Board in the exercise
of its powers
Section 7(3), Cap. 138 (Correction of register)
 The Board may direct the deletion of any entry:

 Requests in writing  No longer practising

 Died  Practise without obtaining practicing
 Absent from Hong Kong not less than 2 years certificate more than 6 months
and without giving intention to return  Obtain registration by fraudulent means
Certificate of Registration
Section 9(1), Cap. 138 (Certificate of registration as a pharmacist)
 Upon the registration, the Secretary shall issue to him a certificate in the specified form
Section 9(3) Cap. 138
 If remove from register in accordance with direction of disciplinary committee
 The pharmacist shall return the certificate to the Secretary
 If lost or destroyed, deliver a signed statement to the Secretary
Section 9(2), Cap. 138 (Certificate of registration as a pharmacist)
 Request for duplicate certificate and issued upon payment of a prescribed fee
 If Lost or destroyed
 The secretary satisfied that the original has been lost or destroyed
 Other reasons
 The Secretary satisfied that a duplicate is required for good reason
Certificate of Good Standing
Section 9A, Cap. 138 (Certificate of good standing)

 The Secretary may, upon application and upon payment of the prescribed fee,
issue to a person whose name has been entered on the register of pharmacists
under section 5 a certificate of good standing.
Practising Certificate
Section 10A(1), Cap. 138 (Registered pharmacist not to practise without practising
certificate)

 A registered pharmacist shall not practise without a practising certificate which is in force
Section 10A(2), Cap. 138 (Registered pharmacist not to practise without practising certificate)
 The Secretary, upon application and subject to the payment of prescribed fee, conditions and
restriction, shall issue a practising certificate
Section 10A(6), Cap. 138 (Registered pharmacist not to practise without practising certificate)
 Shall be deemed to have obtained the certificate when he has duly applied to the Secretary and paid
the prescribed fee
Section 10A(5), Cap. 138 (Registered pharmacist not to practise without practising certificate)
 The holder of certificate ceases to be registered, the certificate shall be deemed to be cancelled
Practising Certificate
Section 10A(2A), Cap. 138 (Registered pharmacist
not to practise without practising certificate)

 A practising certificate must be in the

specified form
Practising Certificate
Section 10A(3), Cap. 138 (Registered pharmacist not to practise without practising
certificate)
 An application made during the course of a year, the certificate shall be in force
from the time of its issue until the end of that year
Section 10A(4), Cap. 138 (Registered pharmacist not to practise without practising
certificate)
 In respect of the following year, the practising certificate shall be in force for a
period of 12 months commencing on 1 January
Section 10B(1), Cap. 138 (Recovery of practising fees)
 If any registered pharmacist contravenes subsection (1) of section 10A, the
amount of the prescribed fee payable by him under subsection (2) shall be
recoverable as a civil debt.
Section 10B(3), Cap. 138 (Recovery of practising fees)
 On recovery from a registered pharmacist of a prescribed fee, the Secretary shall
issue the registered pharmacist with the appropriate practising certificate
Misuse of Certificates of Registration
Section 10(1), Cap. 138 (Misuse of certificates of registration)

 An offence
• With intent to deceive
• Forge, use, lend to or allow to be used
• Certificate of registration as a pharmacist or
• Any certificate relating to pharmacy issued in Hong Kong or elsewhere
under enactment
• Make or possess a closely resembling document
• calculate to deceive
Code of Professional Conduct
Section 4B(1), Cap. 138 (Codes of conduct and
codes of practice)

 The Board may issue codes of conduct and codes

of practice to provide practical guidance
 Section 15, Cap. 138 (Appointment of Disciplinary
Committee)
 If a complaint is received or appears to the Board
that a registered pharmacist or an employee of a
registered pharmacist, has contravened a code of
conduct, the Board may appoint a Disciplinary
Committee to inquire into the conduct of the
person concerned
 Disciplinary Committee

Composition
Powers to conduct inquiry, exam witness and
summons
Give Directions
Time effect of directions
Disciplinary Procedures
Appeal
Relative Legislative Provisions
 Part 5, Cap. 138 (Registered Pharmacists and Authorized Sellers of Poisons:
Disciplinary Proceedings and Restriction on Use of Titles)
 Section 15 (Appointment of Disciplinary Committee)
 Section 16 (Powers of a Disciplinary Committee)
 Section 16A (Powers of Disciplinary Committee at inquiries)
 Section 17 (Liability of authorized sellers of poisons for acts of employees)
 Section 18 (Voting of Disciplinary Committee)
 Section 19 (Provisions as to directions or findings given by Disciplinary Committee)
 Disciplinary Procedures for Pharmacist
 Pharmacists (Disciplinary Procedure) Regulations, Cap. 138E
Appointment
Section 15, Cap. 138 (Appointment of Disciplinary Committee)
• Appointed by the Board to inquire the conduct of the persons concerned
• Persons to be inquired
• Registered pharmacist and his/her employee
• ASP/ employee, officer or partner of ASP
• Situations
• Complaint received regarding the conduct
• Contravene code of conduct / code of practice
• Convicted of an offence under DDO (Cap.134), AO (Cap. 137) or UMAO (Cap. 231) or
under section 52, 54 or 61 of Public Health and Municipal Services Ordinance (Cap. 132)
or under section 7, 7A or 9 of the Trade Description Ordinance (Cap. 362)
• Contravene condition imposed upon registration of premises of ASP
• Appear necessary or desirable to the Board to inquire into the conduct
Composition
Section 15, Cap. 138 (Appointment of Disciplinary Committee)

 A Disciplinary Committee consist of

 Medical Officer as the Chairman appointed by the CE, the same MO in the
Board
 2 Registered pharmacists nominated by PSHK and not being public officers
 A legally qualified person acting as the legal adviser shall be appointed by CE
Power to conduct an inquiry
Section 16(1) and 16(1A), Cap. 138 (Powers of a Disciplinary Committee)

 A Disciplinary Committee shall hold an inquiry into the conduct of any person according
with the prescribed procedure
Section 16A(1) and 16A(3), Cap. 138 (Powers of a Disciplinary Committee)
 Hear and examine witnesses on oath
 Summon person to attend the inquiry
- To give evidence, produce documents and examine him as a witness
- Refuse or neglect to do or answer to question or product document shall be guilty of an
offence – Conviction to a fine at level 3 and to imprisonment for 3 months
Power to conduct an inquiry
Section 16A(5) Cap. 138 (Powers of a Disciplinary Committee at inquiries)

 Any person who—

(a) behaves in an insulting manner or uses any threatening or insulting
expression to or in the presence of the Disciplinary Committee; or
(b) wilfully disrupts the proceedings of the Disciplinary Committee,
 shall be guilty of an offence and shall be liable on conviction to a fine at level
3 and to imprisonment for 3 months.
Directions at the conclusion of an Inquiry
Section 16(2), Cap. 138 (Powers of a Disciplinary Committee)

 A Disciplinary Committee may:

 in respect of a registered pharmacist or an employee of a registered pharmacist, direct
the Secretary
 Censure the registered pharmacist
 Issue a warning letter
 Remove his name from the register and not to re-enter for such directed period
 In respect of an ASP or employee, officer or partner of ASP
- Issue a warning letter
- Remove from register until expiry date or shorter period
- Disqualified for specified period
- Variations of conditions to the registration
Time of effect of Direction
Section 16(2A), Cap. 138 (Powers of a Disciplinary Committee)
 Direction taken effect
 If consider it in the public interest to bring immediate effect – immediately
 If no appeal has been lodged on the specified date by the Disciplinary Committee, being a
date
a) after the expiry of the period for lodging an appeal and
b) on or before the expiry of 3 months from direction made
 If an appeal has been lodged, on the date on which the appeal is finally determined

Section 16(2B) and (2C), Cap. 138 (Powers of a Disciplinary Committee)

 May suspend operation of direction made
 Subject to conditions it thinks fit to impose and suspend for a period not exceeding 3 years
 Direction only taken effect if condition is contravened during the suspension period
 Contravention has been committed then specify a date the direction is to take effect,
being a date
a) after the expiry of the period for lodging an appeal and
b) on or before the expiry of 3 months from the finding is made
Disciplinary Procedures
for Pharmacist
 Set out in Pharmacists (Disciplinary
Procedure) Regulations, Cap. 138E
Disciplinary Procedures for Pharmacist
 Regulation 3, Cap. 138E (Representation)
 A party to an inquiry may be represented by a solicitor or by a solicitor and counsel
 Regulation 13, Cap. 138E (Inquiry by the Disciplinary Committee)
 The legal adviser of Disciplinary Committee shall be present in the inquiry
 Regulation 4, Cap. 138E (Record of proceedings)
 A shorthand writer may be appointed by a Disciplinary Committee to prepare a verbatim
record
 If a verbatim record of an inquiry has been prepared, the chairman, on application to him
by any party and on payment to him of a fee of $43 for each folio of 72 words or part
thereof, shall furnish such party with a copy of such record
 Regulation 11(1), Cap. 138E (Evidence)
 The rules of evidence shall not apply to an inquiry
Disciplinary Procedures for Pharmacist
 Regulation 5(1), Cap. 138E (Opening of inquiry)
 The Secretary shall read the notice of inquiry at the opening
 Regulation 5(2), Cap. 138E (Opening of inquiry)
 If the defendant is neither present nor represented by a solicitor or counsel at the opening
of the inquiry, the Disciplinary Committee may proceed with the absence of defendant
 Regulation 5(3), Cap. 138E (Opening of inquiry)
 The Chairman shall inform the defendant, if he is present, of his right to cross-examine
witnesses, to give evidence and to call witnesses on his behalf
 Regulation 6(2), Cap. 138E (Order of procedure)
 The complaint or his solicitor or counsel, or in their absence or in case of no complainant,
the Secretary may open the case against the defendant and call evidence in support
thereof
Disciplinary Procedures for Pharmacist
 Regulation 11(2), Cap. 138E (Evidence)
• A witness may be examined by the party producing him and cross-examined by the other
party and re-examined upon matters arising out of such cross-examination
 Regulation 11(3), Cap. 138E (Evidence)
• A Disciplinary Committee may decline to admit a written statement unless the maker is
available and willing to give evidence
 Regulation 11(4), Cap. 138E (Evidence)
• The Chairman and any member may put questions to witness as he may think desirable
 Regulation 6(3), Cap. 138E (Order of procedure)
• When the case against the defendant is closed, the defendant may submit that
insufficient evidence has been adduced and the Disciplinary Committee can find that the
charge has been proved
Disciplinary Procedures for Pharmacist
 Regulation 6(4), Cap. 138E (Order of procedure)
 If a submission is made under paragraph (3)
a) a reply thereto may be made by the complainant and the defendant may
answer such reply; and
b) the Disciplinary Committee shall uphold or reject the submission
 Regulation 6(5), Cap. 138E (Order of procedure)
 If the Disciplinary Committee upholds a submission made under para (3), the
finding shall be recorded that the defendant is not guilty on that charge
 If the Disciplinary Committee rejects the submission, the Chairman shall call upon
the defendant to make his defence
 Regulation 6(6), Cap. 138E (Order of procedure)
 The defendant may open his case, call evidence and address the Disciplinary
Committee
Disciplinary Procedures for Pharmacist
 Regulation 6(7), Cap. 138E (Order of procedure)
 At the conclusion of the defendant’s case, the complainant or in their absence, the
Secretary may address the Disciplinary Committee in reply, if evidence has been
called by the defendant other than his own evidence
 Regulation 7(1), Cap. 138E (Postponement of judgement)
 At the conclusion of the proceedings, the Disciplinary Committee may reach and
announce its decision, or postpone its decision to future date
 Regulation 8(1), Cap. 138E (Notice of determination of judgement)
 If the decision is postponed, the Secretary shall, not less than one week before the
date fixed, serve on the defendant and any complainant a notice specifying the date,
time and place at which the decision will be announced
Disciplinary Procedures for Pharmacist
 Regulation 10(1), Cap. 138E (Address in mitigation)
• Before passing sentence, the Chairman shall ask the defendant and he may
address the Disciplinary Committee in mitigation and call evidence as to the
character and antecedents of the defendant
 Regulation 10(2), Cap. 138E (Address in mitigation)
• Before sentence is passed –
a) the person presenting the case may produce to the Disciplinary Committee
the record of any direction made against the defendant and
b) the defendant may address the Disciplinary Committee in mitigation
 Regulation 9, Cap. 138E (Passing sentence)
• The Chairman shall pass sentence on the defendant if a Disciplinary
Committee finds the defendant guilty of a charge
Appeal on direction or finding
 Section 16(3), Cap. 138 (Powers of a Disciplinary Committee)
• A person whom a direction or finding has been made, he may, within 28 days after
receipt of notice, appeal to the Court of First Instance
• The Court of First Instance may affirm, reverse or vary the direction or finding of the
Disciplinary Committee
Appeal on direction or finding
 Section 16(7), Cap. 138 (Powers of a Disciplinary Committee)
An appeal to the Court of First Instance shall be deemed to be finally determined when the
earliest of the following events occurs
 When the appeal to the Court of First Instance is withdrawn or abandoned
 When the specified period expires without an appeal lodged to the Court of Appeal
against a judgment of the Court of First Instance
 When the appeal to the Court of Appeal is withdrawn or abandoned
 When the specified period expires without an application for leave to appeal made to the
Court of Appeal
 Section 16(9), Cap. 138 (Powers of a Disciplinary Committee)
In the case of an appeal to the Court of Appeal or an application for leave to appeal
- it has a period of 28 days within which the notice referred or if the Court of Appeal
extends that period
Appeal on direction or finding
 Section 16(7), Cap. 138 (Powers of a Disciplinary Committee)
An appeal to the Court of First Instance shall be deemed to be finally determined when the
earliest of the following events occurs
 If, before the expiry of the specified period, an application for leave to appeal is made to the
Court of Appeal
- when the application is withdrawn or abandoned
- if the application is refused, when it expires without an application for leave to appeal made
to the Court of Final Appeal or
- if granted, then the appeal to the Court of Final Appeal is withdrawn, abandoned or disposed of
 If, before the expiry of the specified period, an application for leave to appeal is made to the
Court of Final Appeal
- When the application is withdrawn, abandoned or refused or
- If granted, the appeal to the Court of Final Appeal is withdrawn , abandoned or disposed of
Appeal on direction or finding
 Section 16(8), Cap. 138 (Powers of a Disciplinary Committee)
• First, apply for certificate from the Court of First Instance and is so granted
• Apply within 14 days from the judgment

• Second, apply for leave to appeal to the Court of Final Appeal and is so granted
• Apply within 28 days from the date on which the certificate is granted OR
• Application made for extension of time – [leave]
Thank you