Public Announcement > Press Release of Department of Health > Registration system for proprietary Chinese medicines implemented

Registration system for proprietary Chinese medicines implemented

The Chinese Medicine Council of Hong Kong (CMCHK) implements a registration system for proprietary Chinese medicines today (December 19). Starting from today until June 30, 2004, all proprietary Chinese medicines manufactured, imported, or possessed in Hong Kong should apply for registration with the CMCHK's Chinese Medicines Board (CMB).

Dr. Daniel Tse, Chairman of CMCHK, said at a press conference today: "The registration system for proprietary Chinese medicines is an important milestone in the regulation of Chinese medicines. Through the registration system, the safety, quality and efficacy of proprietary Chinese medicines can be assured, and the health of the citizens can be protected."

"Proprietary Chinese medicines manufactured or sold in Hong Kong on 1 March 1999 will get transitional registration, provided that the concerned manufacturers or wholesalers of proprietary Chinese medicines submit an application during the application period for transitional registration," Dr Tse said.

Application for transitional registration should be submitted during December 19 2003 to June 30 2004. Late applications will not be accepted. Proprietary Chinese medicines not eligible for transitional registration should also submit application during the same application period, to allow the CMB to process the applications and issue the 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 the public.

Dr. P Y Lam, the CMB chairman and the Director of Health, said: "The CMB and the Department of Health will conduct briefings for the trade on the details of registration requirements for proprietary Chinese medicines, the application procedures, and the documents and information required."

"In determining an application for registration, the CMB 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. Besides, the product should not be adulterated with western medicines and it should comply with the law on protection of endangered species. The details are described in the "Registration of Proprietary Chinese Medicines Application Handbook” for reference by the applicants. The CMB 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 for the Chinese medicines traders and pertinent organizations on relevant matters,” Dr. Lam said.

"The Department of Health shall 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 CMB will de-register the medicine, and the trader concerned has to recall it from the market."

The "Registration of Proprietary Chinese Medicines Application Handbook" and the application forms are now distributed at Chinese Medicine Division of Department of Health at 32/F, Wu Chung House, 213 Queen's Road East and Chinese Medicines Section at 16/F, Two Landmark East, 100 How Ming Street, Kwun Tong, Kowloon. For more details, please telephone 2574 9999 or visit the website of the CMCHK (www.cmchk.org.hk).

Under the licensing system for Chinese medicines traders which was implemented in May 2003, four kinds of Chinese medicines traders, including retailers and wholesalers of Chinese herbal medicines, and manufacturers and wholesalers of proprietary Chinese medicines, must apply for licences from the CMB. During the period from May to November 2003, the CMB received about 6,900 applications for Chinese medicines trader licences.

 

End/Friday, December 19, 2003