Registration of Proprietary Chinese Medicines > Transitional registration of proprietary Chinese medicines

The application period for transitional registration of proprietary Chinese medicines is from 19 Dec 2003 to 30 June 2004. According to section 128 of the Chinese Medicine Ordinance, for proprietary Chinese medicine manufactured, sold or supplied for sale in Hong Kong on 1 Mar 1999, an applicant may apply within the above-mentioned application period to the Chinese Medicines Board for registration under the transitional arrangements. If the proprietary Chinese medicine under application is eligible for transitional registration, it may be deemed to have been registered.

Except for Chinese medicine injections, for any proprietary Chinese medicines that is eligible for transitional registration, an applicant may choose to apply for registration in any registration groups. For Chinese medicine injection that is eligible for transitional registration, an applicant can only apply for registered under Group III. For details, please refer to the application handbook.

For proprietary Chinese medicines sold or manufactured in Hong Kong after 1 March 1999, the applicant will not be eligible to apply for registration under the transitional arrangements. Applications must be submitted within the above-mentioned application period in order to facilitate the issue of the certificate of registration.

The concerned application had been closed. And since 31 March 2008, the Chinese Medicines Board has started to issue the "Notice of confirmation of transitional registration of proprietary Chinese medicine" to applicants of the products fulfilling the transitional registration requirements.

 

Application result

If the proprietary Chinese medicine under application is eligible for transitional registration, it may be deemed to have been registered. A Notice will be issued by the Chinese Medicines Board confirming that the pCm is accepted for transitional registration. Such registration shall continue in effect until the issue of a certificate of registration or the refusal of their application or such date as specified and promulgated by the Secretary for Food and Health, whichever is the earliest.

 

Documents to be submitted after approval of transitional registration

To facilitate the processing of transitional registration of proprietary Chinese medicines (pCm) to formal registration, holders of "Notice of confirmation of transitional registration of pCm" are required to submit, according to the registration groups chosen, the necessary documents in respect of safety, quality and efficacy within the period specified by the Chinese Medicines Board (CMB). For details, please refer to the Documents required for transitional registration of pCms (Table 1). A "Certificate of registration of pCm" will be issued if the pCm has been assessed by the CMB as meeting the registration requirements.

Having regard to the situation of the trade, the CMB resolved in June 2013 to extend the deadline for holders of "Notice of confirmation of transitional registration of pCm" to submit product specification, method and certificate of analysis and general stability test report of the pCm from 30 June 2013 to 30 June 2015. For details, please refer to the Letter to Holders of "Notice of confirmation of transitional registration of pCm" from the Chinese Medicine Council of Hong Kong dated 26 June 2013 (Chinese version only). In addition, the CMB has formulated a set of arrangements regarding the processing of transitional registration of pCm to formal registration so as to expedite the processing. For details, please refer to the Updated arrangement for processing transitional registration of pCm to formal registration (Chinese version only) and the Letter to Holders of "Notice of confirmation of transitional registration of pCm" from the Chinese Medicine Council of Hong Kong dated 19 May 2014 (Chinese version only).

Having considered the latest situation of submission of reports by the trade, the CMB has decided to maintain the deadline of submission of product specification, method and certificate of analysis and general stability test report. Holders of "Notice of confirmation of transitional registration of pCm" should submit the above reports for their pCm on or before 30 June 2015.

In addition, in order to safeguard public health and to avoid delaying the progress of assessment of the application for registration of pCm by the CMB, if holders of "Notice of confirmation of transitional registration of pCm" cannot submit quality documents for their pCm according to the above arrangements, the CMB will consider refusing the application at an appropriate time. For details, please refer to the Letter to Holders of "Notice of confirmation of transitional registration of pCm" from the Chinese Medicine Council of Hong Kong dated 13 May 2015 (Chinese version only).

 

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