Legislation Notes by Sharon Tang

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 requirements (R.19)

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

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 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 – 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 – 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

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