According to section 123 of the Chinese Medicine Ordinance (the Ordinance) and section 30(1) of the Chinese Medicines Regulation, the "Certificate of Registration of proprietary Chinese medicine" (Certificate) of a proprietary Chinese medicine (pCm) registered under section 121 of the Ordinance shall have effect for a period of 5 years. Certificate holders will receive a "Notice of Renewal of Certificate of Registration of proprietary Chinese medicine" (Notice) before expiry of the Certificate and they may apply to the Chinese Medicines Board (CMB) for renewal of registration.
If a holder decides not to apply for renewal of registration of his pCm, he has to inform CMB of the decision by completing the "Reply Slip for Confirmation of Non-renewal of Registration of Proprietary Chinese Medicines" and notify the relevant wholesalers/retailers to recall the pCm before expiry of the registration.
Renewal applications submitted after expiry of the Certificate will not be entertained.
The certificate holder will receive a Notice, an "Application Form for Renewal of Registration of Proprietary Chinese Medicines" and a "Checklist for Submission of Supplementary Documents for Renewal of Registration of Proprietary Chinese Medicines" (sample) from the Chinese Medicines Committee a year prior to the expiry of the Certificate. Applicants have to complete the "Application Form for Renewal of Registration of Proprietary Chinese Medicines" and submit documents related to the renewal within 6 months from the date of the Notice.
Regarding the application requirements for the renewal of pCm registration and the procedures for processing the applications, please refer to the Guidance Notes on Application for Renewal of Registration of Proprietary Chinese Medicines and the Flow Chart for Processing the Renewal of Registration of Proprietary Chinese Medicines.
Applicants have to submit the completed application form together with the required documents through the following means:
by mail to the Chinese Medicine Regulatory Office of the Department of Health (DH); or
in person to the Chinese Medicine Regulatory Office of DH during office hours.
Upon receipt of the application for renewal of registration, the staff of the Chinese Medicine Regulatory Office of DH will issue an acknowledgement receipt to the applicant to confirm receipt of the application and that it will be processed.
If the application for renewal of pCm registration is approved by CMB, the applicant will receive a notification of payment. Upon payment of the relevant fee prescribed under the Chinese Medicine (Fees) Regulation for the issue of a Certificate, the Chinese Medicine Regulatory Office of DH will send out the Certificate by registered post. If the application is refused by CMB, the applicant will also receive a notice specifying the reasons for refusal.
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.