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Legislation Notes
Introduction and updates
Navigating these notes
Ordinances which are covered
Updated notes 2021 to include ATP
Classification update Jan 2024 for ≤ 0.1% Codeine
Updates 2025
Letters to Trade
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
Strategies to remembering PPR drug classifications
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 - Not Substantial Manipulations (for ATP)
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 March 2026 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)
Code of Practice for Licensed Manufacturers
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 Advanced Therapy Products (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
Definitions - Pharmaceutical product and Advanced Therapy Products (ATP)
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