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In Hong Kong, drugs are classified under the Pharmacy and Poisons Ordinance (Cap. 138). This ordinance defines "pharmaceutical products" as substances or combinations of substances used for:

  • Treating or preventing disease
  • Restoring, correcting, or modifying physiological functions
  • Making medical diagnoses

It also includes "advanced therapy products" such as gene therapy, somatic cell therapy, and tissue-engineered products.

Drug classification considers factors like pharmaceutical form, method of use, label indications, and registration status in Hong Kong.

Control Over Registered Drugs 

Registered drugs are subject to various controls over their sale to protect public health. The Poisons List under the Tenth Schedule of the Pharmacy and Poisons Regulations (Cap. 138A) lists ingredients classified as poisons.

These poisons are further categorized under:

  • Different Parts of the Poisons List
  • Other Schedules under the Pharmacy and Poisons Regulations

The classification is based on potency, toxicity, and potential side effects.

Drug Categories 

There are three main drug categories in Hong Kong:

1. Over-The-Counter Medicines (OTC) 

  • Drugs that do not contain poisons
  • Or contain Part 2 poisons
  • The former can be sold in any retail shop
  • The latter can be sold by Authorized Sellers of Poisons (ASP) (pharmacies or dispensaries) and Listed Sellers of Poisons (LSP) (medicine stores)

2. Pharmacy-Only Medicines 

  • Drugs containing Part 1 poisons
  • Can only be sold in pharmacies (ASP)
  • Must be sold in the presence and under the supervision of a registered pharmacist

3. Prescription-Only Medicines 

  • Drugs containing Part 1 Third Schedule poisons
  • Sale must be authorized by a prescription from a:
    • Registered medical practitioner
    • Registered dentist
    • Registered veterinary surgeon

Additional Restrictions 

Some Part 1 Poisons are further classified into:

First Schedule 

  • Requires sales records including:
    • Date of sale
    • Name, ID number, address, and signature of the purchaser
    • Name and quantity of the medicine
    • Purpose for which it is required

Third Schedule 

  • Requires a valid prescription for sale

Other Ordinances 

  • Antibiotics (under the Antibiotics Ordinance - Cap. 137)
  • Dangerous Drugs (under the Dangerous Drugs Ordinance - Cap. 134)
  • Both are also considered prescription-only medicines

Regulatory Guidelines 

The Pharmacy and Poisons Board provides guidelines and lists of substances generally considered medicinal, such as antibiotics and paracetamol.

Possession or sale of unregistered pharmaceutical products or prescription drugs is illegal in Hong Kong. All pharmaceutical products must be registered with the Board.

Freyr Solutions is your trusted partner for navigating the Hong Kong pharmaceutical landscape.