Except for Chinese medicine injections, any pCms, which are used for the purpose of regulating the functional states of the human body, shall be regarded as "Health-preserving medicines" in the "Non-established medicines category". However, the prescription of the "Health-preserving medicines" should not contain any newly discovered Chinese herb, new medicinal part(s) of Chinese herb, active group extracted from Chinese herb or set of active groups extracted from compound prescription. Otherwise, the pCm will be required for registration under the "New medicines category".
For documents required for various registration groups, please refer to Table 2: Documents required for registration of pCm.
For technical requirement for various tests on safety, quality and efficacy of pCm, please refer to the relevant technical guidelines compiled by the Chinese Medicines Board. (Download).
Applicants may obtain Application handbook for registration of proprietary Chinese medicines, the Application form, the Guide for Completion of Application Form and 「Checklist (1), (2) & (3) 」 in any of the following ways:
Visit the Chinese Medicine Regulatory Office of the Department of Health during office hours:
Address : 16/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, Kowloon
Office Hours: Monday to Friday: 9:00 am to 5:30 pm
Saturday, Sunday & Public Holidays: Closed
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The completed Application Form and applicable checklist (Group I : Checklist (1) or Group II : Checklist (2) or Group III : Checklist (3)), together with all the required documents should be submitted :
Upon receipt of the application for registration, the Chinese Medicine Regulatory Office of the Department of Health will carry out a preliminary check on the documents submitted. If the documents are sufficient and complete, the applicant will, within a short period of time, receive a confirmation receipt to confirm that the application is being processed. The confirmation receipt will include the file reference number allocated to that application.
For the required fees, please refer to Fees. Chinese Medicine Regulatory Office will issue a General Demand Note to the applicant. The applicant could make payment according to the payment methods stated in the General Demand Note.
The application will be assessed by the Chinese Medicines Board. The applicant will be issued a "Certificate of registration of proprietary Chinese medicine" upon payment of the prescribed issue fee if his application is approved. The certificate is valid for 5 years.