Hong Kong Pharmacist Registration Exam Tutorials – Legislation Notes

• Introduction

• The Ordinance/Regs that apply to you

• S.27: Labelling Poisons

• Exemptions for medicine (S.28).

• Extensions and relaxations

• Additional Provisions for Labelling (R.12)-17)

• Transport of poisons (R.21).

• R.31 – Labelling requirements for manufacturers

• Sale of medicines

• Part 2 and non-particular labelling-Poisons (R.38A)

• PPB Code of Ethics – Mandatory labelling requirements to be dispensed medicine

• Institutions (R.22.23).

• Dangerous Drugs (cap 134A)

• Storage requirements (R.19).

• Wholesale – The ordinance contains relevant sections

• Definition

• Wholesalers (R.25)

• Wholesale dealers who can sell to (R.27).

• Records (R.28).

• Recall system (R.28(8)).

• Application for wholesale license (R.26).

• Wholesale of Dangerous Drugs

• Wholesale Dealer License Holders: Code of Practice

• Manufacturing – Introduction & the GMP

• Manufacturer licensing (R.29).

• Authorized Person (R.30A).

• Obligations & Duties

• Supervision (R.30).

• Workers’ health and hygiene (R.32).

• Premises (R.34)

• Labelling (R.31).

• Quality Control and Recall System, R.33

• Record keeping (R.35)

• Supply and sale (R.27).

• Dangerous drugs

• Definitions

• Registration Products and Substances – Introduction

• Registration R.36 – Products and Substances

• Particulars to register (R.36A(3)).

• Registration certificate (R.36(5)

• R.36B – Clinical trials and medicinal tests

• Factors that are relevant for the determination of applications (R.37).

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• Dangerous Drugs – Introduction

• Definitions

• The Dangerous Drugs List – Schedule 1

• Codeine is an example of forensic classification

• Homework

• Trafficking (S.4)

• Supply (S.5)

• S.10: Import, Export and Transit-21)

• Authority to procure and supply (S.22)-23)

• LSPs/ASPs (S.24).

• People who can possess DD (S.25),

• Prescription of DD (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 Apply

• Section 4 – Supply and Sale of Antibiotic Substances

• Section 4 – Administration of Antibiotics

• Section 4 – Prescription requirements

• Section 5 – Possession Antibiotics

• Section 6 – Antibiotic permits

• Section 7 – Record keeping

• Schedule 8: Notification that no prescribed antibiotics can be sold

• Section 9 – Inspections and enforcement

• Cap 137A – Antibiotics Regulations

• Undesirable Medical Advertisements Ordinance

• Definitions

• Prohibitions & Exceptions

• Schedule 1 – Prohibitions and exceptions continue

• Schedule 2 – The reasons it is forbidden to advertise any medicine or surgical device, or treatment

• Responsibilities

• Certain defences

• Prohibitions and exceptions for orally consumed products

• Penalty, power of amend, enforcement