|
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 generally categorised into Chinese medicines and pharmaceutical products (commonly known as “western medicines"), and are regulated under the Chinese Medicine Ordinance (Cap. 549) and the Pharmacy and Poisons Ordinance (Cap.138) respectively.
The Chinese Medicine Regulatory Office of the DH is responsible for the enforcement of the Chinese Medicine Ordinance. For more detail, please visit www.cmro.gov.hk.
Apart from the Pharmacy and Poisons Ordinance (Cap.138) and the Chinese Medicine Ordinance (Cap.549), the Dangerous Drugs Ordinance (Cap. 134), the Antibiotics Ordinance (Cap. 137), the Undesirable Medical Advertisements Ordinance (Cap. 231) and the Import and Export Ordinance (Cap.60) also provide regulations in the control of medicines in Hong Kong.
This article gives an introductory overview of the existing drug regulatory framework of western medicines in Hong Kong.
Pharmacy and Poisons Ordinance (Cap. 138)
Registration of medicines
Under the Pharmacy and Poisons Ordinance, all pharmaceutical products should be registered with the Pharmacy and Poisons Board of Hong Kong (the "Board") before they can be sold or distributed in Hong Kong. “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.
Pharmaceutical products must satisfy the criteria of safety, efficacy and quality for registration with the Board before they can be sold or supplied in Hong Kong. Such requirement aims at providing the public with safeguard on safety, efficacy and quality of medicines available in the market. The applicant must provide a set of information including complete master formula, specification, certificate of analysis and method of analysis, and manufacturer licence in his/her application for registration, for the approval of the Board.
All registered pharmaceutical products shall bear the Hong Kong registration number in the form of HK-XXXXX on their packages. 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 website of the Board (www.drugoffice.gov.hk/eps/do/en/consumer/search_drug_database2.html)
Classification and control of medicines
According to the laws of Hong Kong, medicines are generally classified into three main categories according to the severity of the diseases they indicated for and the seriousness of the side effects they may cause. Medicines in different categories have to be sold in different licensed retailers under different specified conditions outlined as follows:
Category 1: |
Medicines in this category must be dispensed and sold on doctor’s prescription in Authorized Sellers of Poisons (commonly known as “dispensaries” or “pharmacies”) under the direct supervision of registered pharmacists.
Examples include antihypertensive medicines, oral antidiabetics and tranquillisers. Such “prescription medicines” are used to treat serious diseases. Incorrect dosage or improper use may bring about serious health damage.
According to the Pharmacy and Poisons Ordinance, medicines in this category should be labelled with the words “Prescription Drug 处方药物”. |
|
Category 2: |
Medicines in this category do not require doctor’s prescription but have to be sold in dispensaries by a registered pharmacist or in his presence and under his supervision. The method of use and dosage must be followed to avoid health risks.
According to the Pharmacy and Poisons Ordinance, medicines in this category should be labelled with the words “Drug under Supervised Sales 监督售卖药物”. |
|
Category 3: |
Medicines in this category can be sold in dispensaries or Listed Sellers of Poisons (commonly known as “medicine companies”). Examples of this category of medicines include drugs for common cold, antipyretics and painkillers. They are often used to treat or alleviate minor illnesses and tend to have fewer side effects.
Despite this, members of the public have to bear in mind that improper use of such medicines may also bring about undesirable side effects. If in doubt, consult your doctor, pharmacist or other healthcare professionals, and refrain from indiscriminate self-medication. |
Licensing of medicine dealers
In general, the drug supply chain consists of manufacturers, wholesalers and retailers. They are all subject to licensing control under the Pharmacy and Poisons Ordinance.
Manufacturers
Under the Pharmacy and Poisons Ordinance, all pharmaceutical manufacturers in Hong Kong must obtain a Licence for Manufacturer before commencing operations. They have to comply with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Good Manufacturing Practice (GMP), which is part of quality assurance to ensure that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use. DH conducts inspections against the licensees to ensure that they are in compliance with GMP and other regulatory requirements.
Wholesalers
Traders dealing with wholesale and/or import/export of pharmaceutical products require a Wholesale Dealer Licence. Wholesalers as well as manufacturers are required to keep their medicines under suitable conditions. They are also required to set up a system that will enable the effective recall of medicines from the market when the products are found to be dangerous or injurious to health. DH conducts inspections against holders of Wholesale Dealer Licence to ensure their compliance with the regulatory requirements.
Retailers
Under the Pharmacy and Poisons Ordinance, there are two kinds of medicine retailers: Listed Seller of Poisons (LSP) and Authorized Seller of Poisons (ASP). DH conducts inspections against licensed medicine retailers to ensure their compliance with legal requirements.
- Listed Seller of Poisons (LSP)
LSP, commonly known as “medicine companies”, are only allowed to sell the category 3 medicines as mentioned above.
- Authorized Seller of Poisons (ASP)
ASP, commonly known as “pharmacies” or “dispensaries”, are authorized to sell all 3 categories of medicines under specific conditions. Dispensaries may display “℞” logo in the prescribed form while LSP or other drug retailers must not display the “℞” logo. The name, the certificate of registration and working hours of the pharmacist must be displayed in a conspicuous location inside the ASP. The Ordinance requires that medicines in the above categories 1 and 2 must be sold under the supervision of registered pharmacists at the premises of ASP. Illegal sale of controlled medicine is an offence and subject to a maximum penalty of $100,000 fine and 2 years’ imprisonment.
Import and Export Ordinance (Cap. 60)
Importation and exportation of products that fall within the definition of pharmaceutical products are controlled under the Import and Export Ordinance (Cap. 60). Importation/exportation of pharmaceutical products in Hong Kong must be covered by a licence issued by Department of Health under delegated authority of the Director-General of Trade and Industry Department. The Import and Export Ordinance is enforced by the Customs and Excise Department.
Undesirable Medical Advertisements Ordinance (Cap. 231)
The Undesirable Medical Advertisements Ordinance prohibits the advertisements likely to lead to the use of any medicine, surgical appliance or treatment for the purpose of treating human beings for, or preventing them from contracting listed diseases or conditions or purposes specified in Schedules 1 and 2 of the Ordinance, and prohibits/restricts advertising of six groups of claims specified in Schedule 4 for all orally consumed products, in order to prevent the adverse effects of improper self-medication by members of the public. DH regularly screens medical advertisements from different media and actions will be taken against those who contravene the Ordinance.
Antibiotics Ordinance (Cap. 137) and Dangerous Drugs Ordinance (Cap. 134)
Some medicines may be classified as antibiotics or dangerous drugs under the Antibiotics Ordinance and Dangerous Drugs Ordinance respectively. Both antibiotics and dangerous drugs are prescription medicines and they could only be sold on doctor’s prescription in registered pharmacies under the supervision of a registered pharmacist.
Monitoring of marketed drugs
Apart from the above regulatory control, DH has a market surveillance system in place to monitor the safety, efficacy and quality of drugs. DH collects marketed medicines via different channels, including the Internet, for analysis. If a product is found to be not of the required quality or adulterated with harmful substances, public announcement will be made as soon as possible to alert and advise members of the public. |
Drug Office
Department of Health
October 2024 |
