Hong Kong Pharmacist Registration Exam Tutorials – 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

• 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)

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• 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