Under Chinese Medicines Regulation, the registration particulars for a proprietary Chinese medicine includes:
The holder of a certificate of registration may apply for approval to vary the registered particulars of the proprietary Chinese medicines. However, the product name, the dose form and the name and quantity of any active ingredient shall not be varied. Any variation in any of these three particulars will require a new application for registration of the pCm.
The holder of a "notice of confirmation of transitional registration of proprietary Chinese medicines" ("notice") may apply for approval to vary the following particulars of the proprietary Chinese medicine: (i) trademark text; (ii) holder of certificate (i.e. "notice"); and/or (iii) name and address of the manufacturer(s).
Application forms and guidelines can be obtained from the Chinese Medicines Section of the Department of Health or by fax through automatic enquiry hotline system (Enquiry number：2574 9999) or downloaded from this homepage.
The application form should be duly completed and returned, together with the relevant documents, to the Chinese Medicines Section of the Department of Health.
If the proposed variation will not adversely affect the safety, quality and efficacy of the proprietary Chinese medicine, the Chinese Medicines Board may approve the application, and will inform the applicant in writing.