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Legislation Notes
Introduction and updates
Navigating these notes
Ordinances which are covered
Updated notes 2021
Classification update Jan 2024 for ≤ 0.1% Codeine
Sections of the PPO and PPR - Cap 138 and 138A
Navigating the PPO and PPR
PPO Schedule 37 - Chinese Medicines
PPO Parts 1-3 Sections 2-10
Part 1 - Interpretations
Definitions - Pharmaceutical product and ATP
Part 2 - The PPB and the Codes of Conducts/Practices
Part 3 - Registration of Pharmacists
PPO Part 4 - ASPs, LSPs, and the retail sale of Poisons
Introduction - ASPs, LSPs, and Basics of Poisons Categorisations
The Poisons List and Schedules 1, 3, and 10
Medicines that can be kept in ASPs and LSPs
Section 11 - Authorised Seller of Poisons (ASP)
Section 12 - Each premises is required to be under the control of a pharmacist
Section 13 - Registration of premises
Code of Practice for ASPs
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
Sections 15-20
PPO Part 6 - Sale and Possession of Poisons
Sections 21-24 - Part 1 Poisons
Sections 25 and 26 - Listed Seller of Poisons (LSP)
Sections 27-28 - Labelling, Exemptions
PPO Parts 7 and 8
Part 7 - Import and export of Pharmaceutical Products
Part 8 - Miscellaneous
PPO Schedule 1
Schedule 1
Labelling (PPO and PPR)
Introduction
Relevant sections of the Ordinance/Regs
Definition
Section 27 - Labelling of Poisons
Section 28 - Labelling exemptions relating to medicines supplied by healthcare professionals and ASPs
Regulation 4 - Extensions and relaxations
Regulations 12-17 - Supplementary Provisions for labelling
Regulation 21 - Transporting of poisons
Regulation 31 - Labelling requirements for manufacturers
Regulation 38 - Sale of medicines
Regulation 38A - Labelling of Part 2 and Non-Poisons
PPB Code of Practice - Mandatory labelling requirements for dispensed medicines
Regulations 22-23 - Institutions
Dangerous Drugs (cap 134A)
DOH Aug 2021 Labelling Guidelines
Storage (PPR)
Regulations 19 and 24 - Storage
Wholesale of Pharmaceutical Products (PPR Part 6)
Wholesale - Relevant sections in the ordinance
Definition
Regulation 25 - Who can wholesale
Regulation 26 - Application for wholesale dealer license
Regulation 27 - Who wholesale dealers can sell to
Regulation 28 - Record keeping and Recall System for WDL and LM
Wholesale of Dangerous Drugs (DDO)
Code of Practice for Holder of Wholesale Dealer License
Manufacturers (PPR Part 7)
Manufacturing - Definitions and Regulation 28A the GMP
Substantial manipulation of cells or tissues and PPO Schedule
Regulation 29 - Licensing of manufacturers
Regulation 30 - Supervision
Regulation 30A to F - Authorised Person
Regulation 31 - Labelling
Regulation 32 - Health and hygiene of workers
Regulation 33 - Quality Control and Recall System
Regulation 34 - Premises
Regulation 35 - Record keeping for manufacturers
Regulation 28 - Record keeping and Recall System for WDL and LM
Regulation 27 - Sale and supply
Dangerous drugs
Registration of pharmaceutical products and substances (PPR Part 8)
Registration of products and substances - Introduction
Definitions - Pharmaceutical product and ATP
Regulation 36 - Registration of products and substances
Regulation 36B - Clinical trials and medicinal tests
Regulation 37 - Factors relevant to determination of applications
PPR Regulation 39 - Keeping and Transfer of Records
Regulation 39 - Retaining and Transfer of Records
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 (updated 2024)
Section 4 - Trafficking
Section 5 - Supply of DDs
Sections 10-21 - International Import, Export, and Transit
Sections 22-23 - Authority for certain persons to procure, supply and possess
Section 24 - Statutory Authority for ASPs and LSPs
Section 25 - People who are allowed to possess DD
Sections 26-27 - Who is allowed to ingest/inject and owning apparatus equipment to inject DDs
Section 28 - Statutory authority of masters of ships
Section 30 - Supplying DDs to hospitals
Section 31 - Supply of DD on prescription
Regulation 3 - Prescription requirements
Regulation 4 - Labelling
Regulations 5-7 - Record keeping
Antibiotics Ordinance (Cap 137)
Antibiotics Ordinance - Sections 1 & 2
Section 3 - Substances to which the Antibiotics Ordinance applies
Section 4 - Control of Sale and Supply of AO Antibiotics
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 - List of AO Antibiotics
Undesirable Medical Advertisements Ordinance (Cap 231)
Undesirable Medical Advertisements Ordinance
Section 2 - Definitions
Section 3 - 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
Schedule 4 - Prohibitions and Exceptions for Orally Consumed Products
Responsibility
Section 5 - Certain defences
Section 8 - Penalty, power to amend, enforcement
Import and Export Ordinance Cap 60
Introduction
Section 6C and 6D - Restriction on import/export of certain prohibited articles
Additional requirements
Dangerous Drugs
Section 31 - Supply of DD on prescription
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