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Arrangement for holders of HKP who fail to submit the test reports by the expiry date of submission

The Chinese Medicines Board (CMB) of the Chinese Medicine Council of Hong Kong has decided to maintain the deadline of the submission of product specification documents and general stability test reports. Holders of "Notice of confirmation of transitional registration of proprietary Chinese medicines (pCm)" (HKP) should submit the above documents and test reports for their pCm on or before 30 June 2015. For those holders of HKP who fail to submit the above documents and reports on or before 30 June 2015, the CMB resolves to take the following action :

After 30 June 2015, the CMB will issue reminder letter to those HKP holders who have not submitted the product specification documents and general stability test reports, requiring them to submit the aforementioned documents and reports within three months. Relevant holders should submit the product specification documents and general stability test reports within three months. If the relevant holders cannot submit the product specification documents and general stability test reports within three months, they should provide sufficient reason (e.g. evidence issued by a testing center that testing being conducted) for consideration by the CMB. Otherwise, the related pCm registration application may be rejected by the CMB. For details, please refer to the Letter from the Chinese Medicine Council of Hong Kong dated 18 May 2015 (Chinese version only).