Service Introduction
Service Content
Proprietary Chinese medicines that are not subject to the registration regime as provided in Article 26(2)(3) to (6) of Law No. 11/2021 “Law on Pharmaceutical Activities in Traditional Chinese Medicine and Registration of Proprietary Chinese Medicines” must obtain approval from the Pharmaceutical Administration Bureau before manufacture, import or use.
Service recipients and application eligibility
- Hospitals providing healthcare services in the Macao SAR;
- Clinical trial centres;
- Laboratories conducting research and development of pharmaceutical products;
- Applicants for registration of proprietary Chinese medicines;
- Traditional Chinese Medicine doctors;
- Masters of Traditional Chinese Medicine;
- Traditional Chinese Medicine pharmacists;
- Others.
Service result
The Pharmaceutical Administration Bureau will issue a certificate of approval to applicants who submit an application and meet the review and approval requirements.
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
E-mail: info@isaf.gov.mo