Chinese Medicine Division

End of product quality reports submission period for transitional registration of proprietary Chinese medicines

The Department of Health (DH) reminds the public that the Chinese Medicines Committee (CMSC) under the Chinese Medicine Council of Hong Kong (CMCHK) has today notified the Chinese medicines traders who did not submit the required test reports by the deadline, that their applications for registration of relevant proprietary Chinese medicines (pCm) were refused.  The respective “Notice of Confirmation of Transitional Registration of pCm” (HKP) issued will become invalid on 17 Nov 2015.  By that date, these products should discontinue to be supplied or sold in the market.  The CMCHK will remove these products from the “Lists of applications for proprietary Chinese medicine registration” of the CMCHK website (http://www.cmchk.org.hk/pcm/eng/#main_dis.htm) on the same day.  Details about the affected products will also be uploaded to “What’s New” section (http://www.cmchk.org.hk/pcm/eng/#main_news.htm).

According to the Chinese Medicine Ordinance (Cap. 549)(the “CMO”), all pCms must be registered with the Chinese Medicines Board (“CMB”) under the CMCHK before they can be imported, manufactured and sold in Hong Kong.  To get registered in Hong Kong, a pCm must fulfil the registration requirements regarding safety, quality and efficacy as prescribed by the CMB.

Having taken into account the history and practical circumstances of the sale of pCms in Hong Kong, the CMO provides an arrangement of transitional registration.  For pCms manufactured, sold or supplied for sale in Hong Kong on 1 March 1999, registration could be made under the transitional arrangement (HKP).

HKP shall continue in effect until the formal registration of that pCm and the issue of the Certificate of Registration (“HKC”); or the refusal of the application for registration of that pCm; or such date as may be specified and promulgated by the Secretary of Food and Health by notice in the Gazette, whichever is the earliest.

The CMB has started to issue HKP since 31 March 2008.  Holders of HKP were required to submit product quality reports within the period specified by the CMB; otherwise, the CMB may consider refusing the application in accordance with the CMO.

As of today, holders of more than 90% of some 8,000 pCm issued with HKP have submitted the specified product quality reports.  For the remaining 361 pCms, the CMSC has issued today “Notice of refusal to pCm registration application” to their relevant holders, notifying the refusal of their applications for pCm registration, which shall take effect on 17 Nov 2015.

While the relevant pCms have not been shown to cause harm to human, members of the public should not consume unregistered pCms.  If needed, the public may surrender such pCm(s) to the Chinese Medicine Division of the Department of Health on 16/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, Kowloon during the following office hours for disposal :-

Office Hours:

  • Monday to Friday : 9:00 a.m. to 5:30 p.m.
  • Close on Saturday, Sunday and Public Holidays

To facilitate members of the public to access the information of pCms sold in the Hong Kong market, the CMCHK has provided on the website (http://www.cmchk.org.hk/pcm/eng/#main_dis.htm) searchable records of pCms, including information on pCms issued with HKP and HKC.  For any enquiries, the public may call the hotline set up by the DH at 3904 9130.

Chinese Medicine Division
Department of Health
12 November 2015