Chinese medicine manufacturers or wholesalers must submit their applications for transitional registration on or before June 30.

The Chinese Medicine Council said under the registration system, all proprietary Chinese medicines manufactured, imported, or possessed in Hong Kong should apply for registration with the council's Chinese Medicines Board.

Proprietary Chinese medicines manufactured or sold in Hong Kong on March 1, 1999, will get transitional registration provided they submit an application by June 30. Late applications will not be accepted.

Those not eligible for transitional registration should also submit applications during the same period, to allow the board to process the applications and issue certificates of registration as soon as possible.

When the first round of registration work is completed, nobody shall sell, import or possess any unregistered proprietary Chinese medicines in Hong Kong. All registered proprietary Chinese medicines are required to print their registration number on the outer-most package for identification by consumers.

A milestone in Chinese drugs regulation

The council said the registration system is an important milestone in the regulation of Chinese medicines, saying that the safety, quality and efficacy of proprietary Chinese medicines can be assured, and the health of citizens can be protected.

In determining an application for registration, the board shall take into account the factors of safety, quality and efficacy in respect of the product.

The registration requirements include compliance with the standard on limits of heavy metals and toxic elements, pesticides remains and microbes. The product should not be adulterated with western medicines and it should comply with the law on protection of endangered species.

Sample checks to be conducted

The Department of Health will sample-check the proprietary Chinese medicines sold on the market on a regular basis. When a registered proprietary Chinese medicine is found to be hazardous to health, the board will de-register the medicine, and the trader concerned has to recall it from the market.

Details are described in the Registration of Proprietary Chinese Medicines Application Handbook. The board has also developed the Guidelines for Recall of Chinese Medicine Products, the technical guidelines on testing of proprietary Chinese medicines, and Good Clinical Practice for Proprietary Chinese Medicines, to provide guidance.

The handbook and application forms are available at the Department of Health, 32/F, Wu Chung House, 213 Queen's Road East, and the Chinese Medicines Section, 2/F Public Health Laboratory Centre, 382 Nam Cheong Street, Kowloon.

For more details, please call 2574 9999 or visit the Chinese Medicine Council  website.