Licensing of Chinese Medicine Traders > Manufacturer licence in proprietary Chinese medicines

"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.

 

How to obtain application forms

Application forms and the Handbook of the Application for Chinese Medicines Trader Licences can be obtained from:

  1. Chinese Medicine Division, Department of Health

  2. All district offices of the Home Affairs Department (Enquiry no.:2835-2500)

The above-mentioned documents can be downloaded from this website and the relevant application forms can be obtained by fax through the automatic enquiry hotline system of the Chinese Medicine Division of the Department of Health (tel.: 2574-9999)

 

Submission of documents or information

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. The required documents include:

  1. Copy of Business Registration Certificate

  2. For limited company,

    1. Copy of Certificate of Incorporation; and

    2. Copy of Directors' List, such as Form AR1 of the Companies Registry or a full set of Form D1 (in case of a newly established limited company) ; OR

    For sole proprietorship, copy of Form 1(a) of Business Registration Office; OR

    For partnership, copy of Form 1(c) of Business Registration Office

  3. 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)

  4. Brief floor plan of business premises

  5. List of manufacturing equipment for proprietary Chinese medicines

  6. Evidence of academic qualifications and /or documentary proofs of relevant working experience of the person and his deputies responsible for the supervision of the manufacture of 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 Division 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 Division of the Department of Health.

 

Application results and duration of the licence

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 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.

 

Licensing fees and methods of payment

For the required fees, please refer to Fees. Chinese Medicine Division 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.

 

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