What is the legal framework for registration of medicines?
In Hong Kong, the Department of Health (DH) is responsible for overseeing the safety, efficacy and quality of all medicines marketed in Hong Kong. Medicines can be divided into Chinese medicines and non-Chinese medicines (or western medicines) as they are regulated under different Ordinances, i.e. Chinese Medicine Ordinance (Cap.549) and Pharmacy and Poisons Ordinance (Cap.138) respectively.
Both Chinese herbal medicines and proprietary Chinese medicines are regulated by the Chinese Medicine Regulatory Office of the DH. For more details, please refer to www.cmro.gov.hk.
According to the laws of Hong Kong, pharmaceutical products (medicines) must be registered with the Pharmacy and Poisons Board of Hong Kong (PPB) before they can be sold, offered for sale, distributed or possessed for the purposes of sale, distribution or other use in Hong Kong
Under the Pharmacy and Poisons Ordinance, “Pharmaceutical product”—
(a) means a substance, or combination of substances that —
(i) is presented as having properties for treating or preventing disease in human beings or animals; or
(ii) may be used in or administered to human beings or animals with a view to —
(A) restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action; or
(B) making a medical diagnosis; and
(b) includes an advanced therapy product.
Persons responsible for making new drug applications (the applicant) include:
(a) If the pharmaceutical product is manufactured in Hong Kong, the person responsible for obtaining registration of the product is the licensed manufacturer, or the licensed wholesale dealer contracting with the licensed manufacturer.
(b) If the pharmaceutical product is manufactured outside Hong Kong, the person responsible for obtaining registration is the licensed wholesale dealer who imported the pharmaceutical product, or the Hong Kong branch, subsidiary, representative, agent or distributor of the overseas manufacturer.
The PPB is established under the Pharmacy and Poisons Ordinance to carry out functions in accordance with the provisions of the said Ordinance and its subsidiary legislation, such as registration and classification of pharmaceutical products. The Drug Office of the Department of Health provides professional and executive support to the PPB and its executive committees.
What are the requirements for registration?
Pharmaceutical products are required to conform to the standards on safety, efficacy and quality before they can obtain registration as stipulated under the Pharmacy and Poisons Regulations (Cap. 138A). Such requirement aims at providing the public with safeguard on safety, efficacy and quality of medicines available in the market. Therefore, the applicant has to provide a set of information including but not limited to description and composition of the product, product specification, relevant test reports, manufacturer licence, clinical and scientific documentation substantiating the safety and efficacy of the product, etc. in the process of application for registration for consideration of registration approval by the PPB.
How to identify a registered medicine?
(I) Registration number
Upon registration, the medicine will be given by the PPB a registration number, in the format of HK-XXXXX, which is provided on the medicine label. Members of the public can therefore check whether the registration number is present on the label, and to check whether the medicine is registered or not.
(II) Label information
Apart from the registration number, the label of a registered medicine should bear the following general information:
- Name of the product
- Name and quantity of each active ingredient
- Name and address of the manufacturer
- Batch number
- Expiry date
- Product pack size and unit of quantity
- Storage condition (including specific storage condition, if any)
- Instructions for use, dosage and dosing intervals, if the medicine is to be sold over the counter (i.e. medicine that is to be sold without pharmacist supervision and/or without doctor’s prescription)
Members of the public may check whether a medicine is registered in Hong Kong or not by using the "Search Drug Database" function available at the following link
(www.drugoffice.gov.hk/eps/do/en/consumer/search_drug_database2.html), by inputting parameters such as "Active Ingredient", "Product/Drug Name", "HK Registration No.", etc. using the advanced search.
Complaints
For any complaint on registered or non-registered medicines, you may wish to call 2572 2068 or email to pharmgeneral@dh.gov.hk.
Drug Office
Department of Health
August 2024
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