Under the Pharmacy and Poisons Ordinance, Cap.138 of the Laws of Hong Kong, “manufacture” means the preparation of pharmaceutical products for sale or distribution and “manufacturer” has a corresponding meaning. It shall not include the individual dispensing on a prescription or otherwise of any pharmaceutical products.
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| Part VII of the Pharmacy and Poisons Regulations relates to the licensing of pharmaceutical manufacturers. No person shall manufacture any pharmaceutical product on any premises unless he is the holder of a licence to manufacture pharmaceutical products on those premises. |
| Secondary packaging is a manufacturing step and means the labelling, re-labelling, cartoning, re-cartoning or adding additional information (including inserts) to pharmaceutical products which are already enclosed in the container in which they are to be sold or supplied. |
| The licensing authority is the Pharmacy & Poisons (Manufacturers Licensing) Committee (the Committee), an Executive Committee established under the Pharmacy and Poisons Board. The licensing requirements to be met in awarding a manufacturer licence and during licence renewal include – |
| (a) | the manufacturing process under the supervision of a registered pharmacist or person approved by the Board ; |
| (b) | proper labelling of pharmaceutical products manufactured ; |
| (c) | premises used in the manufacturing, testing, packing and dispatch of pharmaceutical products being suitable for the purpose; |
| (d) | adequate hygiene control of personnel and premises to avoid contamination of pharmaceutical products ; |
| (e) | quality assurance of raw materials and finished products with retention of control sample and all related records; and |
| (f) | compliance with the “Hong Kong Good Manufacturing Practices Guidelines for Pharmaceutical Products”, and for new applicants, compliance with the “Guide to Good Manufacturing Practices for Medicinal Products” and it annexes (where applicable) published by the Pharmaceutical Inspection Cooperation Scheme
(PIC/S)
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Each product will also need to be registered with the Pharmacy and Poisons Board under Part VIII of the Regulations by the manufacturer before it can be sold or distributed in Hong Kong. |
A licensed manufacturer selling his own products by way of wholesale dealing does not require a wholesale poisons licence, but he shall comply with the requirements under Part VI of the Regulations in the same way as a wholesale dealer. |
Manufacture of Dangerous Drugs is required to hold an additional licence issued by the Director of Health under the Dangerous Drugs Ordinance, Cap. 134. |
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