Registration of Proprietary Chinese Medicines > Non-established medicines category (Other medicines category)

For the time being, "Other medicines category" under the "Non-established medicines category" includes "Single Chinese medicine granules". "Single Chinese medicine granules" are those granules that fall within the definition of pCm, and are made from single Chinese herbs, and their claimed indications and functions are the same as those of their crude drugs.

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).

 

How to obtain application forms and other relevant information

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:

  1. 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

  2. Download from this homepage

 

How to submit the application

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 :

  1. By mail to the Chinese Medicine Regulatory Office of the Department of Health by registered post (the date of the post stamp will be taken as the submission date); or
  2. By hand to the Chinese Medicine Regulatory Office of the Department of Health during office hours.

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.

 

How to pay the application fees

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.

 

Application result

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.

 

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