Registration of Proprietary Chinese Medicines > Variation of particulars of registered proprietary Chinese medicines

Under Chinese Medicines Regulation, the registration particulars for a proprietary Chinese medicine includes:

  1. the Chinese and English name;
  2. the dose form;
  3. the name and quantity of each of its active ingredient;
  4. the specification;
  5. the dosage and method of usage;
  6. each of the labels to be attached or printed on the package;
  7. the package insert to be supplied for its sales inside Hong Kong;
  8. the name and address of each of its manufacturer;
  9. its function or pharmacological action.
  10. the name and quantity of each of its excipient (if any);
  11. its indication (if any);
  12. each of the package inserts to be supplied for its sales outside Hong Kong (if any);

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).

 

How to obtain application forms

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´╝Ü2574 9999) or downloaded from this homepage.

 

How to submit the application

The application form should be duly completed and returned, together with the relevant documents, to the Chinese Medicines Section of the Department of Health.

 

Application result

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.

 

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