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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 for 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, among other items, 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 the 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 March 1, 1999, in Hong Kong. Manufacturers, importers or local agents/representatives of manufacturers outside Hong Kong were allowed to apply for transitional registration for such pCm on or before June 30, 2004. Subject to the CMB's vetting and approval, a "Notice of confirmation of transitional registration of proprietary Chinese medicines" is issued for applications which meet the eligibility criteria for transitional registration.
As at September 2010, the CMB had received about 16,710 applications for registration of pCm, of which about 14,100 also applied for transitional registration. The CMB has assessed all the applications for transitional registration and issued a "Notice of confirmation of transitional registration of pCm" for 9,150 applications and a "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 give the trade adequate time to comply with the requirements for 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 a 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.
Ends/Friday, October 8, 2010
Issued at HKT 18:14
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