According to Section 133 of the Chinese Medicine Ordinance, licensed proprietary Chinese medicines manufacturers may apply to the Chinese Medicines Board for a certificate for manufacturer to certify that they follow the requirements of good practices in manufacture and quality control of proprietary Chinese medicines (GMP).
The manufacturers must be licensed manufacturers in proprietary Chinese medicines.
The manufacturers must prove that they follow the requirements of good practices in manufacture and quality control of proprietary Chinese medicines. Please refer to the "Hong Kong Good Manufacturing Practice Guidelines for Proprietary Chinese Medicines" issued from the Chinese Medicines Board for the relevant requirements.
The Guidance Notes on the Application for Certificate for Manufacturer (Good Manufacturing Practice in respect of Proprietary Chinese Medicines), the Documentation Requirements on Application for Certificate for Manufacturer (Good Manufacturing Practice in respect of Proprietary Chinese Medicines) (Guidelines for the Trade) and relevant application forms 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 Certificate for Manufacturer (Good manufacturing practice in respect of proprietary Chinese medicines) (Form 1E) with the Documentation Checklist - Application for Certificate for Manufacturer (Good manufacturing practice in respect of proprietary Chinese medicines) (Checklist 2E) accompanied by all the documents listed therein.
Applicants may submit the application and pay application fees by the following ways:
Mail to the Chinese Medicine Regulatory Office, Department of Health by registered post ;
Lodge with the office of the Chinese Medicine Regulatory Office, Department of Health in person during office hours.
After receiving an application, staff of the Chinese Medicine Regulatory Office will check the submitted application form, documentation, information and application fees. If all the required information is submitted, the Chinese Medicine Regulatory Office will shortly issue a letter of acknowledgement to the applicant to confirm that the application is being processed. If any of the required information is found to be omitted, the Chinese Medicine Regulatory Office will send a letter to remind the applicant to submit the omitted documents as soon as possible for further processing of the 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 Chinese Medicine Regulatory Office of 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.
The Chinese Medicines Board will approve the application within 2 months upon full compliance with the legal and relevant Good Manufacturing Practice Guidelines requirements.
The applicant will be notified in writing if the application is approved by the Board. Certificate for manufacturer will be sent to the applicant by post. The applicant may choose to go to Chinese Medicine Regulatory Office to collect the certificate in person during office hours. The applicant will be notified in writing if the application is refused. The validity period will be shown on the certificate, and normally it shall be not more than 2 years.
In response to the 2010-11 Policy Address that the industry will be actively engaged in working out a timetable for mandatory compliance with the Good Manufacturing Practice for the manufacture of proprietary Chinese medicines, the Chinese Medicines Board recommends adoption of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP standard as a licensing requirement for local manufacturers in proprietary Chinese medicine, and implementation of PIC/S GMP standard in 4 years.
Considering the operational needs and sufficient preparation time for the implementation of GMP, the Department of Health is collecting opinions from the industry on the timetable through conducting sharing sessions and meetings with Chinese medicines associations. If the industry has any comments on the implementation of GMP, please send to the Chinese Medicine Regulatory Office of the Department of Health (Address: 16/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, Kowloon; Fax no.: 2778-1085; E-mail address: email@example.com). When you make the submission, please indicate your manufacturer licence number. The Department of Health will consolidate all opinions and submit to the Chinese Medicines Board for consideration.