Regulation of Chinese Medicines

According to the Chinese Medicine Ordinance, regulatory measures relating to

Chinese medicines shall be divided into two areas as follows:

1. The licensing of Chinese medicines traders: Chinese medicines traders who

wish to engage in the business of retail and wholesale of Chinese herbal
medicines as well as the wholesale and manufacturing business of proprietary
Chinese medicines must first apply for the relevant licence from the Chinese
Medicines Board. They may continue operating their own business only after
they have obtained the licence.
2. The registration of proprietary Chinese medicines: All kinds of proprietary
Chinese medicines must first be registered by the Chinese Medicines Board
before they can be imported, manufactured and distributed in Hong Kong.

According to the Chinese Medicine Ordinance, Chinese herbal medicines mean the
toxic Chinese herbal medicines specified in Schedule 1 of the Ordinance and the
Chinese herbal medicines specified in Schedule 2 of the Ordinance which are
commonly used in Hong Kong.

And "proprietary Chinese medicine" means any proprietary product -

a. composed solely of the following as active ingredients-

i. any Chinese herbal medicines,
ii. any materials of herbal, animal or mineral origin customarily used by the
Chinese; or
iii. any medicines and materials referred to in subparagraphs (i) and (ii)
respectively;
b. formulated in a finished dose form; and
c. known or claimed to be used for the diagnosis, treatment, prevention or
alleviation of any disease or any symptom of a disease in human beings, or for
the regulation of the functional states of the human body;

The Chinese Medicines Board has formulated the "Guidance Notes on How to
Classify Products as proprietary Chinese medicines". For details please refer to the
contents of this guideline.

Apart from the foregoing restrictions, according to the Import and Export Ordinance
(Cap.60 of the Laws of Hong Kong), any person who wishes to import or export any
of the Chinese herbal medicines specified in Schedule 1 or the 5 types of the Chinese
herbal medicines specified in Schedule 2 as well as any proprietary Chinese medicines
must first apply for an import or export licence.

Besides, the Protection of Endangered Species of Animals and Plants Ordinance (Cap.
586) imposes regulation on proprietary Chinese medicines containing ingredients of
endangered species. For more information, please refer to the pamphlet
on "Endangered Species Protection - Traditional Chinese Medicines" published by the
Agriculture, Fisheries and Conservation Department.

The legislations including the Chinese Medicine Ordinance, Chinese Medicines

Regulation, Chinese Medicines (Fees) Regulation and Chinese Medicines Traders
(Regulatory) Regulation should be taken as the standards for regulation of Chinese
medicines. The Laws of Hong Kong can be downloaded from the Internet
(Website: www.elegislation.gov.hk). Otherwise, you can purchase the publication(s)
by: