Service Introduction
Service Content
Registration of natural medicines to be placed in circulation in Macao.
Note: In accordance with Article 1(2) of Law No. 11/2021 “Law on Pharmaceutical Activities in Traditional Chinese Medicine and Registration of Proprietary Chinese Medicines”, the relevant provisions of the said Law shall apply, with the necessary adaptations, to natural medicines.
Service recipients and application eligibility
- In accordance with Article 1(2) and Article 28(1) of Law No. 11/2021 “Law on Pharmaceutical Activities in Traditional Chinese Medicine and Registration of Proprietary Chinese Medicines”, natural or legal persons who manufacture natural medicines, either themselves or by commission, in or outside the Macao SAR, may apply for the registration of natural medicines, provided they cumulatively meet the following requirements:
- Must have domicile in the Macao SAR, in the case of a natural person, or be legally established in the Macao SAR, in the case of a legal person;
- Must not be subject to an ancillary penalty, ancillary sanction, or security measure that prohibits them from engaging in pharmaceutical activities; in the case of a legal person, its managers and members of the administrative bodies must also meet this requirement;
- Must not be subject to an ancillary penalty, ancillary sanction, or security measure that prohibits them from applying for registration of proprietary Chinese medicines; in the case of a legal person, its managers and members of the administrative bodies must also meet this requirement;
- Must have no debts subject to compulsory collection through tax enforcement proceedings.
2. In accordance with Article 1(2) and Article 28(2) of Law No. 11/2021 “Law on Pharmaceutical Activities in Traditional Chinese Medicine and Registration of Proprietary Chinese Medicines”, an applicant who cumulatively meets the following requirements may apply for the registration of natural medicines for the purpose of importing them for circulation in the Macao SAR, provided the natural medicines are already registered or have been granted a marketing authorization outside the Macao SAR:
- Be the holder of a license for the import, export, and wholesale of Chinese medicines / be a firm for the import, export, and wholesale of pharmaceutical products;
- Must not be subject to an ancillary penalty, ancillary sanction, or security measure that prohibits them from applying for registration of proprietary Chinese medicines.
Service result
After the applicant for registration of natural medicines has passed the review procedure and met the registration requirements, the Pharmaceutical Administration Bureau will issue a Certificate of Registration of Natural Medicine to the applicant.
Enquiry Channels
Executing department and unit: Pharmaceutical Administration Bureau – Department of Registration – Division of Traditional Chinese Medicines
Correspondence address: Avenida do Comendador Ho Yin, Edifício de Escritórios do Governo (Qingmao), 19.º andar, Macau
Tel.: (853) 2883 1908
Fax: (853) 2852 4016
Email: info@isaf.gov.mo