Sharon Tang – Legislation Notes

• 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

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• 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, enforcemen