"Manufacture of proprietary Chinese medicines" means the preparation, production, packing or re-packing of proprietary Chinese medicine for sale or distribution.
Applicants who manufacture proprietary Chinese medicines must first obtain a manufacturer licence in proprietary Chinese medicines.
Application forms and the Handbook of the Application for Chinese Medicines Trader Licences can be obtained from the Chinese Medicine Regulatory Office of the Department of Health or downloaded from this website.
Applicants are required to submit in person or by registered post the duly completed Application Form for Manufacturer licence in Proprietary Chinese Medicines (Form 1D) with the Documentation Checklist - Application for Manufacturer licence in Proprietary Chinese Medicines (Checklist 2D) accompanied by the required documents listed therein. Applicants may also submit application via online form. The required documents include:
Copy of Business Registration Certificate
For limited company,
Copy of Certificate of Incorporation; and
For sole proprietorship, copy of Form 1(a) of Business Registration Office; OR
For partnership, copy of Form 1(c) of Business Registration Office
Name list of sole proprietor/partners/directors and key personnel (including full names in both Chinese and English, Hong Kong Identity Card numbers / Passport numbers and posts. In the case of a director being a corporation, please state the name and Company Number of the corporation)
Brief floor plan of business premises
List of manufacturing equipment for proprietary Chinese medicines
* [According to section 132 of the Chinese Medicine Ordinance, an application for a manufacturer licence in proprietary Chinese medicines shall include the nominations of a person who will be responsible for the supervision of the manufacture of proprietary Chinese medicines and not more than 2 deputies. Each responsible persons nominated must comply with the minimum requirements regarding knowledge and experience as set out in section 2 of Schedule 1 of the Chinese Medicines Regulation.]
The Chinese Medicine Regulatory Office of the Department of Health will issue a letter of acknowledgement within 30 days upon receipt of an application form. The letter of acknowledgement will contain an application number. Any applicant who does not receive a letter of acknowledgement after the said 30 days shall contact the Chinese Medicine Regulatory Office of the Department of Health.
After receiving an application, the Department of Health will send officers to inspect the applicant's business premises and prepare a report for assessment by the Chinese Medicines Board. If the application is approved by the Board, the applicant will be required to pay the prescribed fee. Upon the receipt of the relevant fee, the Department of Health will send the licence to the applicant by post. If the applicant has already provided email address via designated means, the applicant will also receive an e-licence via email. If an application is refused, the applicant will be notified in writing thereof, and he may initiate a review or appeal against that decision. The duration of the licence will be shown on the licence, and shall be not more than two years.
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.