Sharon Tang – Legislation Notes

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Your Instructor

Sharon Tang

ed 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

Introduction

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