With increasing interaction between Hong Kong and China’s healthcare industries, Hong Kong has received support from both the Central Government of China and the Hong Kong Government in promoting its healthcare services within the mainland China market, and in particular within the Greater Bay Area.
Since 2009 various measures have been introduced to facilitate this development. For example, healthcare service providers in Hong Kong are permitted to set up healthcare institutions in the Greater Bay Area as sole shareholders or in the form of joint ventures with local partners; healthcare professionals who are registered to practice in Hong Kong are permitted to provide short-term services in mainland China. According to the latest news, more than 27 Hong Kong healthcare service providers have established their presence in the Greater Bay Area. There is no doubt that this number will continue to grow.
In November 2019, the Central Government of China further announced that Hong Kong-registered drugs and common medical devices can now be used at designated healthcare institutions established in the Greater Bay Area by Hong Kong healthcare service providers.
Traditionally, Hong Kong has not been the target of pharmaceutical product or device giants due to its small population. However, the new measures provide a great opportunity to pharmaceutical product and device manufacturers all over the world. Many products already registered – or which will be registered in the future – in Hong Kong may be able to enter the mainland China market as a test without going through the existing complicated and lengthy drug registration process. It comes therefore as no surprise that we are witnessing an increasing number of applications for pharmaceutical-related registrations, licences and permits in Hong Kong at this time.
As pharmaceutical-related registrations, licences and permits in Hong Kong are rarely discussed from a legal perspective in the past, we take this opportunity to provide a very general overview of the major registration and licensing requirements in respect of western medicines in Hong Kong.
In Hong Kong, the Department of Health is responsible for overseeing the safety, efficacy and quality of all pharmaceutical products marketed to the public in Hong Kong. Every segment of the pharmaceutical supply chain from manufacturing, the wholesale, and to the retail to the general public, is subject to licensing control under the Department of Health. This includes the registration of pharmaceutical products, manufacturer licences, wholesale dealer licences, import/export licences and retailer licences.
Registration of pharmaceutical products
If a product is considered a “pharmaceutical product” under the Pharmacy and Poisons Ordinance of Hong Kong, it must be registered with the Pharmacy and Poisons Board before it is allowed to be sold, offered for sale, distributed or possessed for the purposes of sale, distribution or other use in the Hong Kong market.
In considering whether a product is a “pharmaceutical product,” the composition of the product and the nature of the claims should be taken into account. In general, if a product contains a controlled substance in its composition or if it carries “medicinal” claims in its label, advertisements and other promotional materials, it will fall within the scope of “pharmaceutical product” and registration will be mandatory before it appears on the Hong Kong market.
If the pharmaceutical product is manufactured in Hong Kong, both the licensed manufacturer and the licensed wholesale dealer can apply to register the product. If the product is manufactured outside Hong Kong, the applicant for registration should be the licensed wholesale dealer importing the product or the local branch, subsidiary, representative, agent or distributor of the overseas manufacturer.
The application for registration is submitted via an online Pharmaceutical Registration System. A set of information must be provided upon submission of the application, including the product’s production formula, product specification, laboratory report and manufacturer licence and so on.
A pharmaceutical product will be approved for registration only if it meets the safety, efficacy and quality criteria set by the Department of Health.
If any pharmaceutical products are manufactured in Hong Kong, the pharmaceutical manufacturer in Hong Kong must obtain a licence before commencing its operation and will be subject to regular inspections conducted by the Department of Health to ensure that they comply with the Hong Kong Good Manufacturing Practice and other regulatory requirements.
Wholesale Dealer Licence
If a company wishes to introduce a pharmaceutical product into Hong Kong, very likely it will need to apply for a Wholesale Dealer Licence due to the legal requirement that any entity involved in the local distribution (including import or export) of pharmaceutical products in Hong Kong must hold a valid Wholesale Dealer Licence.
“Distribution” is defined broadly vis-à-vis the Wholesale Dealer Licence, which includes the procuring, purchasing, holding, storing, selling, supplying, importing, exporting, and the delivery of pharmaceutical products from the premises of a Wholesale Dealer Licence holder to other premises, with the exception of dispensing or supplying pharmaceutical products directly to a patient or to his agent.
One of the major requirements is that the Wholesale Dealer Licence holder must provide designated storage facilities for storing the pharmaceutical products. For companies which do not have their own storage facilities, it is permissible to lease the facilities as long as certain requirements are satisfied.
Although the specific size and condition of the storage facility is to be determined by the amount and nature of the pharmaceutical products, some general requirements should be satisfied such as appropriate temperature and humidity, adequate lighting and ventilation, products being stored away from direct sunlight and suitably spaced, and the installation of an alarm system for temperature-sensitive products. An inspection by a pharmacist inspector will be conducted at the company’s premises and their storage facilities to evaluate whether they are fit for the purposes of the Wholesale Dealer Licence.
In addition to a Wholesale Dealer Licence, an application for a Wholesale Dealer’s Licence to Supply Dangerous Drugs is required if the pharmaceutical product contains ingredients and substances which are considered “dangerous drugs” under the Dangerous Drugs Ordinance of Hong Kong.
In addition to the Wholesale Dealer Licence, any company that would like to import or export pharmaceutical products from Hong Kong, also needs to apply for an Import Licence or Export Licence from the Trade and Industry Department. For every single importation or exportation, an Import/Export Licence must be obtained. It normally takes several working days for such an application to be processed.
Registered pharmaceutical products are also subject to various kinds of control over their retail sale, based on the type / category of the medicine, to protect the health of the public.
Broadly speaking, medicine in Hong Kong is divided into three categories under the law: prescription and under the supervision of registered pharmacists; (ii) Drugs under Supervised Sales, meaning medicines that do not need a prescription, but must be sold under the supervision of registered pharmacists; and (iii) Medicines that can be sold without resident pharmacists (sometimes referred as Over-The-Counter medicines (“OTC”)).
Only “Authorised Sellers of Poisons” (“ASP”) can sell all three categories of medicines. To become an ASP, a company must register its premises with the Department of Health and undergo interviews and inspection during the registration process. The company is required to have a resident registered pharmacist so that the Prescription Drugs and Drugs under Supervised Sales can be sold under the supervision of the registered pharmacist. Typically, the pharmacies and dispensaries in Hong Kong are ASPs.
Normal medicine stores without a resident pharmacist can sell OTC medicines, but they must be licensed as “Listed Seller of Poisons” (“LSP”). For example, many 7-Eleven stores in Hong Kong are on the List of LSPs published by the Department of Health (the “List”). Similar to the ASP application, the Department of Health will conduct an inspection during the LSP application process. Once approved to be an LSP, the entity will be required to pay annual fees to remain on the List.
What we can do for you
The licensing requirements vary depending on the nature of the pharmaceutical products and the particular activities a company aims to conduct in Hong Kong.