Registration of Medicines in Hong Kong
In Hong Kong, medicines are required to be registered under the Pharmacy and Poisons Ordinance Cap 138. The purpose is to ensure that medicines available for sale are safe, effective and of good quality. This is necessary for the protection of the health of members of the general public.
Documents required for registration
For the purpose of registration, the manufacturer is required to provide documents of the product to support its safety, efficacy and quality. The documents usually required are the manufacture and quality control procedure, the clinical study reports and overseas post-marketing study results of the product.
Who should apply for registration?
In the case of a product manufactured in Hong Kong, the manufacturer of the product should obtain registration of the product.
If the product is manufactured outside Hong Kong, the local importer should obtain the registration.
Labelling of registered medicines
Once a medicine is approved for registration, a registration number is issued. The registration number, which is required to be labelled on the sales packs of the medicine, consists of HK-, followed by a 5-digit number, i.e. HK-XXXXX. To avoid the purchase of an unregistered medicine, you should check whether a registration number is on the sales packs of the medicine. Other particulars required to be labelled on a registered medicine are : the name of the product, the manufacturer, and the composition of the active ingredients. Additional information may also be required to be labelled on certain medicines, e.g. cautionary statements, dosage, route and frequency of administration.
A useful source of reference on registered medicines in Hong Kong is the Compendium of Pharmaceutical Products published by the Department of Health. It contains information on the product names, active ingredients and the registration number of the medicines. The printed publication is available for sale by calling the Publications Sales Section of Information Services Department at Tel : 2537 1910 or by email at firstname.lastname@example.org. Enquiries on the registration status of medicine should be directed to the Drug Office of the Department of Health on 2319 8458. For more information, please visit This link will open in a new windowDrug Office Website.