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Sharon Tang – Legislation Notes

Legislation Notes

Going through the sections of the HK Ordinances which are relevant for the Legislation exam

Your Instructor

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

Legislation Notes
Introduction

Introduction

Pharmacy and Poisons Amendments Ordinance 2020

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

Summary of the sections

ASPs, LSPs, and Basics of Poisons Categorisations (PPO)

Introduction – ASPs, LSPs, and Basics of Poisons Categorisations

Medicines that can be kept in ASPs and LSPs

Authorised Seller of Poisons (ASP) (S.11)

Each premises is required to be under the control of a pharmacist (S.12)

Registration of premises (S.13)

Code of Practice for ASPs

Display of Logo, and restriction on use of titles

Listed Seller of Poisons (LSP) (S.25)

Labelling (PPO and PPR)

Introduction

Relevant sections of the Ordinance/Regs

Labelling of Poisons (S.27)

Exemptions for medicines (S.28)

Extensions and relaxations (R.4)

Supplementary Provisions for labelling (R.12-17)

Transporting of poisons (R.21)

Labelling requirements for manufacturers (R.31)

Sale of medicines (R.38)

Labelling of Part 2 and Non-Poisons (R.38A)

PPB Code of Ethics – Mandatory labelling requirements for dispensed medicines

Institutions (R.22,23)

Dangerous Drugs (cap 134A)

Storage (PPR)

Storage requirements (R.19)

Wholesale of Pharmaceutical Products (PPR)

Wholesale – Relevant sections in the ordinance

Definition

Who can wholesale (R.25)

Who wholesale dealers can sell to (R.27)

Records (R.28)

Recall system (R.28(8))

Application for wholesale dealer license (R.26)

Wholesale of Dangerous Drugs

Code of Practice for Holder of Wholesale Dealer License

Manufacture (PPR)

Manufacturing – Introduction and the GMP

Licensing of manufacturers (R.29)

Authorised Person (R.30A)

Obligations and Duties

Supervision (R.30)

Health and hygiene of workers (R.32)

Premises (R.34)

Labelling (R.31)

Quality Control and Recall System (R.33)

Record keeping (R.35)

Sale and supply (R.27)

Dangerous drugs

Definitions

Registration of pharmaceutical products and substances (PPR)

Registration of products and substances – Introduction

Registration of products and substances (R.36)

Particulars to be registered (R.36A(3))

Registration certificate (R.36(5))

Clinical trials and medicinal tests (R.36B)

Factors relevant to determination of applications (R.37)

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

Dangerous Drugs – Introduction

Definitions

The Dangerous Drugs List (Schedule 1)

Example of forensic classification – Codeine

Homework

Trafficking (S.4)

Supply (S.5)

Import, Export, and Transit (S.10-21)

Authority to procure, supply and possess (S.22-23)

ASPs and LSPs (S.24)

People who are allowed to possess DD (S.25)

Supply of DD on prescription (S.31)

Prescription requirements (R.3)

Labelling (R.4)

Record keeping (R.5-6)

Antibiotics Ordinance (Cap 137)

Antibiotics Ordinance – Sections 1 & 2

Section 3 – Substances to which the Antibiotics Ordinance applies

Section 4 – Sale and Supply of Antibiotic Substances

Section 4 – Administration of Antibiotics

Section 4 – Prescription requirements

Section 5 – Possession of Antibiotics

Section 6 – Antibiotic permits

Section 7 – Record keeping

Schedule 8 – Notification that no scheduled antibiotics may be sold

Section 9 – Inspections and enforcement of Ordinance

Cap 137A – Antibiotics Regulations

Undesirable Medical Advertisements Ordinance (Cap 231)

Undesirable Medical Advertisements Ordinance

Definitions

Prohibitions and Exceptions

Schedule 1 – Prohibitions and exceptions continued

Schedule 2 – Purposes for which it is prohibited to advertise any medicine, surgical appliance or treatment

Responsibility

Certain defences

Prohibitions and Exceptions for Orally Consumed Products

Penalty, power to amend, enforcement

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