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In Hong Kong, the Department of Health is responsible for overseeing the safety, efficacy and quality of all medicines marketed in the country. Medicines can be divided into Chinese medicines and non-Chinese medicines (or western medicines) as they are regulated under different ordinances, including Chinese Medicine Ordinance (Cap. 549 of the Laws of Hong Kong) and Pharmacy and Poisons Ordinance (Cap.138 of the Laws of Hong Kong).

Criteria for pharmaceutical registration involves safety, efficacy and quality of the product drug. The process of registration involves evaluation by the pharmaceutical registration committee and the Pharmacy and Poison Board.

For more information, click here. Link to “Overview of Hong Kong Healthcare Environment”.

(A) presented as having properties for treating or preventing disease in human beings or animals; or

(B) that may be used in, or administered to, human beings or animals, either with a view to –

(i) restoring, correcting or modifying physiological functions by exerting a pharmacological,

immunological or metabolic action; or

(ii) making a medical diagnosis.

For more details about the Pharmacy and Poisons Ordinance and Pharmacy and Poisons (Amendment) Ordinance 2015, please refer to the websites below:

https://www.elegislation.gov.hk/index/chapternumber?p0=1&TYPE=1&TYPE=2&TYPE=3&CAP_NO_FR=138&_lang=en

http://www.gld.gov.hk/egazette/pdf/20151905/es1201519052.pdf

As stipulated under Reg.36(1) of the Pharmacy and Poisons Regulations (Cap. 138A), “pharmaceutical products” must be registered before they can be sold, offered for sale, distributed or possessed for the purposes of sales, distribution or other use in Hong Kong.

Sale of unregistered pharmaceutical products is an offence under the Pharmacy and Poisons Ordinance. The maximum penalty is a fine at level 6 of Criminal Procedure Ordinance Cap 221 ($100,000) and two years’ imprisonment.

Registered pharmaceutical products are subject to various kinds of control over their sale to protect the health of the public. In Hong Kong, the Poisons List under the Tenth Schedule of the Pharmacy and Poisons Regulations (Cap. 138A) lists out those ingredients classified as poisons. Some poisons are further categorized under different Parts of the Poisons List and other different Schedules under the Pharmacy and Poisons Regulations (Cap. 138A) according to their potency, toxicity and potential side-effects.

Such categorization determines the different levels of control over their sale. For example, pharmaceutical products that do not contain any poisons or contain Part 2 poisons are referred as Over-The-Counter medicines (OTC). The former can be sold in any retail shops while the latter can be sold in Authorized Sellers of Poisons (ASP, usually known as pharmacies or dispensaries) and Listed Sellers of Poisons (LSP, usually known as medicine stores). Pharmaceutical products containing Part 1 poisons can only be sold in pharmacies (ASP) in the presence and under the supervision of registered pharmacists.

Some Part 1 Poisons are further classified into the First Schedule and the Third Schedule with additional restrictions on their sale at the retailers. The sale of pharmaceutical products containing Part 1 First Schedule poisons further requires keeping sales records which include the date of sale, the name, number of identity card, address and signature of the purchaser, the name and quantity of the medicine as well as the purpose for which it is required. The sale of pharmaceutical products containing prescription only medicines (Part 1 Third Schedule poisons) must be authorized by a prescription from a registered medical practitioner, a registered dentist or a registered veterinary surgeon.

Antibiotics defined under the Antibiotics Ordinance (Cap. 137) and dangerous drugs defined under the Dangerous Drugs Ordinance (Cap. 134) are also prescription only medicines.

The regulation of pharmaceutical products are mainly provided under the following Laws of Hong Kong:

• Pharmacy and Poisons Ordinance (Cap. 138)
• Antibiotics Ordinance (Cap. 137)
• Dangerous Drugs Ordinance (Cap. 134)
• Undesirable Medical Advertisements Ordinance (Cap. 231)
• Public Health and Municipal Services Ordinance (Cap. 132)
• Import and Export Ordinance (Cap. 60)

It takes approximately 9-12 months to complete the pharmaceutical product registration process in Hong Kong, if a secondary review (usually for new chemical entities) is not required. A secondary review will extend the timeframe by approximately 3-6 months.

There is no 100% guarantee for registration approval. Registration approval is depended on the evaluation and review by the Hong Kong Department of Health.

For registration of a pharmaceutical product containing new chemical entities (NCEs), a “secondary review” approach is adopted in Hong Kong. The eligibility of an application depends on the availability of two Certificates of Pharmaceutical Product (CPPs) issued by reference countries. The Department of Health (DH) conducts the initial review and verification of the CPPs and supporting documents. The Pharmacy and Poisons Board (PPB) and its Registration Committee (RC) and Poisons Committee (PC) will then consider giving approval to the registration and the proper classification to control its sale. The NCE will have to be included into the Poisons List under Cap 138 through legislative amendments prior to the registration of the product in question. After gazettal, the applicant will sign an undertaking on reporting requirements before obtaining the registration certificate.

Yes. However, using a distributor as your Hong Kong LRP comes with risks because the LRP is responsible for corresponding with the Department of Health. Distributors may not have the expertise or experience to fulfill this role as your regulatory liaison. Additionally, the LRP must have access to technical documentation, which you may not wish to share.

In Hong Kong, all pharmaceutical manufacturers must obtain a licence from the Pharmacy and Poisons Board of Hong Kong (PPBHK) to produce medicines. One of the key requirements for licensing a pharmaceutical manufacturer is the full compliance with the PIC/S GMP standards. The Drug Office of the Department of Health (DH) provides licensure support to the PPBHK and conducts GMP inspections to ensure compliance.