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Commencement notices for mandatory registration of proprietary Chinese medicine gazetted

8 Oct 2010

The Secretary for Food and Health has made notices to commence offences under the legislation relating to the sale, import and possession of proprietary Chinese medicines (pCm) through registration and the requirements of label and package inserts.

Notices gazetted today (October 8) propose commencement of mandatory registration of pCm on December 3, 2010 and label and package insert requirements on December 1, 2011.

The notices were made pursuant to section 1(2) of the Chinese Medicine Ordinance (Cap 549), section 1 of the Chinese Medicine (Fees) Regulation (Cap 549 sub. leg. E) and section 1 of the Chinese Medicines Regulation (Cap 549 sub. leg. F).

The Chinese Medicine Ordinance (Cap. 549) was enacted in July 1999 to provide a statutory framework for the regulation of the practice of Chinese Medicine as well as use, trading and manufacture of Chinese medicines in Hong Kong. The Chinese Medicine Council of Hong Kong was established in September 1999 under the ordinance to implement these regulatory measures.

Legislative provisions relating to mandatory licensing of Chinese medicine traders and import and export of Chinese herbal medicines became fully effective on January 11, 2008.

Section 119 under the ordinance stipulates, amongst others, that all pCm must be registered by the Chinese Medicines Board (CMB) before they can be imported, manufactured or sold in Hong Kong. To be registered, all pCm must meet the registration requirements prescribed by CMB regarding their safety, quality and efficacy.

To minimise disruption to the Chinese medicine trade, the ordinance provides a transitional registration arrangement for pCm manufactured, sold or supplied for sale on 1 March 1999 in Hong Kong. Manufacturers, importers or local agents/representatives of manufacturers outside Hong Kong may apply for transitional registration for such pCm on or before 30 June 2004. Subject to CMB’s vetting and approval, a “Notice of confirmation of transitional registration of proprietary Chinese medicines” will be issued for applications which meet the eligibility criteria for transitional registration.

As at September 2010, CMB has received about 16 710 applications for registration of pCm, of which about 14,100 also applied for transitional registration. CMB has assessed all the applications for transitional registration and issued "Notice of confirmation of transitional registration of pCm" for 9,150 applications and “Notice of confirmation of (non-transitional) registration of pCm” for 2,120 applications of non-transitional registration.

The proposed commencement date of section 119 is December 3, 2010 when the sale, import or possession of unregistered pCm in Hong Kong will be an offence.

Commencement of sections 143 and 144 is proposed for December 1, 2011 to allow the trade to have adequate time to comply with the requirements of label and package inserts.

The requirement for mandatory registration of pCm is one of the important measures of the regulatory regime of Chinese medicines. Apart from this, other related measures have been put in place, including regulation of pCm manufacturers, setting up of product recall system, enforcing import control of pCm, conducting market surveillance on pCm, as well as other related laws to strengthen the regulation of pCm.

The commencement notices will be tabled in the Legislative Council on October 13, 2010.

  Last Revision Date : 08 October 2010