Hong Kong Pharmacist Registration Exam Tutorials – Legislation Notes

Hong Kong Pharmacist Registration Exam Tutorials – Legislation Notes

Check it out: Hong Kong Pharmacist Registration Exam Tutorials – Legislation Notes

Your Instructor

Sharon Tang
Sharon Tang

Started this online tutorial platform in September 2017. I have a BPharm (1996) and a PhD in Pharmacognosy (2003) obtained from the University of London School of Pharmacy and have worked in community and in hospital in the UK. Since moving to Hong Kong several years ago I have passed the registration exams (2012). I have also taught pharmacology and human disease topics to pharmacy technicians and student nurses, which included writing exams and marking them. The Facebook group I run provides support for pharmacists taking the Hong Kong pharmacy registration exams.

Course Curriculum

Introduction

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Navigating these notes
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Updated notes 2021

Sections of the PPO and PPR – Cap 138 and 138A

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Navigating the PPO and PPR
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PPO Schedule 37 – Chinese Medicines

PPO Parts 1-3 Sections 2-10

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Part 1 – Interpretations
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Definitions – Pharmaceutical product and ATP
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Part 2 – The PPB and the Codes of Conducts/Practices
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Part 3 – Registration of Pharmacists

PPO Part 4 – ASPs, LSPs, and the retail sale of Poisons

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Introduction – ASPs, LSPs, and Basics of Poisons Categorisations
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The Poisons List and Schedules 1, 3, and 10
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Medicines that can be kept in ASPs and LSPs
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Section 11 – Authorised Seller of Poisons (ASP)
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Section 12 – Each premises is required to be under the control of a pharmacist
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Section 13 – Registration of premises
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Code of Practice for ASPs
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Section 13A – Display of Logo, and restriction on use of titles

PPO Part 5 – Pharmacists and ASPs Disciplinary Proceedings and Restriction on Use of Titles

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Sections 15-20

PPO Part 6 – Sale and Possession of Poisons

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Sections 21-24 – Part 1 Poisons
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Sections 25 and 26 – Listed Seller of Poisons (LSP)
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Sections 27-28 – Labelling, Exemptions

PPO Parts 7 and 8, and Schedule 1

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Part 7 – Import and export of Pharmaceutical Products
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Part 8 – Miscellaneous
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Schedule 1

Labelling (PPO and PPR)

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Introduction
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Relevant sections of the Ordinance/Regs
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Definition
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Section 27 – Labelling of Poisons
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Section 28 – Labelling exemptions relating to medicines supplied by healthcare professionals and ASPs
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Regulation 4 – Extensions and relaxations
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Regulations 12-17 – Supplementary Provisions for labelling
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Regulation 21 – Transporting of poisons
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Regulation 31 – Labelling requirements for manufacturers
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Regulation 38 – Sale of medicines
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Regulation 38A – Labelling of Part 2 and Non-Poisons
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PPB Code of Conduct – Mandatory labelling requirements for dispensed medicines
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Regulations 22-23 – Institutions
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Dangerous Drugs (cap 134A)
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DOH Aug 2021 Labelling Guidelines

Storage (PPR)

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Regulations 19 and 24 – Storage

Wholesale of Pharmaceutical Products (PPR Part 6)

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Wholesale – Relevant sections in the ordinance
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Definition
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Regulation 25 – Who can wholesale
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Regulation 26 – Application for wholesale dealer license
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Regulation 27 – Who wholesale dealers can sell to
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Regulation 28 – Record keeping and Recall System for WDL and LM
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Wholesale of Dangerous Drugs (DDO)
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Code of Practice for Holder of Wholesale Dealer License

Manufacture (PPR Part 7)

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Manufacturing – Definitions and Regulation 28A the GMP
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Substantial manipulation of cells or tissues (PPO Schedule)
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Regulation 29 – Licensing of manufacturers
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Regulation 30 – Supervision
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Regulation 30A to F – Authorised Person
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Regulation 31 – Labelling
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Regulation 32 – Health and hygiene of workers
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Regulation 33 – Quality Control and Recall System
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Regulation 34 – Premises
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Regulation 35 – Record keeping for manufacturers
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Regulation 28 – Record keeping and Recall System for WDL and LM
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Regulation 27 – Sale and supply
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Dangerous drugs

Registration of pharmaceutical products and substances (PPR Part 8)

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Registration of products and substances – Introduction
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Definitions – Pharmaceutical product and ATP
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Regulation 36 – Registration of products and substances
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Regulation 36B – Clinical trials and medicinal tests
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Regulation 37 – Factors relevant to determination of applications

PPR Regulation 39 – Keeping and Transfer of Records

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Regulation 39 – Retaining and Transfer of Records

Dangerous Drugs Ordinance and Regulations (DDO cap 134 and DDR 134A)

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Dangerous Drugs – Introduction
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Definitions
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The Dangerous Drugs List (Schedule 1)
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Example of forensic classification – Codeine
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Section 4 – Trafficking
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Section 5 – Supply of DDs
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Sections 10-21 – International Import, Export, and Transit
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Sections 22-23 – Authority for certain persons to procure, supply and possess
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Section 24 – Statutory Authority for ASPs and LSPs
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Section 25 – People who are allowed to possess DD
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Sections 26-27 – Who is allowed to ingest/inject and owning apparatus equipment to inject DDs
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Section 28 – Statutory authority of masters of ships
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Section 30 – Supplying DDs to hospitals
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Section 31 – Supply of DD on prescription
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Regulation 3 – Prescription requirements
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Regulation 4 – Labelling
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Regulations 5-7 – Record keeping

Antibiotics Ordinance (Cap 137)

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Antibiotics Ordinance – Sections 1 & 2
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Section 3 – Substances to which the Antibiotics Ordinance applies
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Section 4 – Control of Sale and Supply of AO Antibiotics
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Section 5 – Possession of Antibiotics
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Section 6 – Antibiotic permits
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Section 7 – Record keeping
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Schedule 8 – Notification that no scheduled antibiotics may be sold
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Section 9 – Inspections and enforcement of Ordinance
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Cap 137A – Antibiotics Regulations – List of AO Antibiotics

Undesirable Medical Advertisements Ordinance (Cap 231)

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Undesirable Medical Advertisements Ordinance
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Section 2 – Definitions
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Section 3 – Prohibitions and Exceptions
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Schedule 1 – Prohibitions and exceptions continued
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Schedule 2 – Purposes for which it is prohibited to advertise any medicine, surgical appliance or treatment
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Schedule 4 – Prohibitions and Exceptions for Orally Consumed Products
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Responsibility
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Section 5 – Certain defences
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Section 8 – Penalty, power to amend, enforcement

Import and Export Ordinance Cap 60

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Introduction
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Section 6C and 6D – Restriction on import/export of certain prohibited articles
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Additional requirements
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Dangerous Drugs