Service Introduction
Registration of proprietary Chinese medicines (pCms) used in the Macao SAR.
Service target and eligibility:
- Individuals or companies who manufacture proprietary Chinese medicines in the Macao Special Administrative Region or abroad are eligible to apply for registration of proprietary Chinese medicines under Article 28(1) of Law No. 11/2021 on “the Pharmaceutical Activity in the Field of Traditional Chinese Medicines and the Registration of Proprietary Chinese Medicines”.
- An individual applicant must reside in the Macao Special Administrative Region; a company applicant must be legally incorporated in the Macao Special Administrative Region.
- An applicant is not subject to additional penalties or punishments that would prevent him or her from engaging in pharmaceutical activities; in addition, the manager and members of the administration must also meet this requirement in the case of a company.
- An applicant is not subject to additional penalties or punishments that would prevent him or her from engaging in registration of traditional Chinese medicines; in addition, the manager and members of the administration must also meet this requirement in the case of a company.
- Tax enforcement procedures are not being used to enforce the applicant’s debts.
2. Applicants who meet the following requirements may apply to register proprietary Chinese medicines for distribution in the Macao Special Administrative Region when importing proprietary Chinese medicines registered or licensed for sale outside the Macao Special Administrative Region, as specified in Article 28(2) of the Law on “the Pharmaceutical Activity in the Field of Traditional Chinese Medicines and the Registration of Proprietary Chinese Medicines”.
- Chinese medicines import, export and wholesale licence holders, or Firm for Import, Export and Wholesale of Pharmaceutical Products
- The applicant is not subject to any additional penalty, additional fine or security sanction that prohibits him from applying for registration of proprietary Chinese medicines.
Result of application: Applicants applying for registration of proprietary Chinese medicines who have met the registration requirements may obtain a Certificate of Registration of Proprietary Chinese Medicines from the Pharmaceutical Administration Bureau (ISAF).
Enquiry
Executive 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
Telephone: (853) 2883 1908
Facsimile: (853) 2852 4016
E-mail: info@isaf.gov.mo