How to Apply:
Time of application:
According to paragraph 2 of article 8 of Decree-Law no. 59/90/M dated 19th September, “The review application should be lodged three months before the registration expiry date”.
Application procedures and documents required:
- Manufacturer’s statement, together with any test report or change of information (if applicable); the statement shall include the following
- Report of the lack of efficacy or public safety risk during the marketing of the medicine (if any);
- If there is any change to the volume and packaging of the medicine;
- If there is any change to the formula and production method of the medicine.
- The latest quality analysis report of the medicine;
- The latest report on the long-term stability of the medicine;
- Other necessary documents or information requested by the Pharmaceutical Administration Bureau.
Location of Application and Service Hours
Location of application: Pharmaceutical Administration Bureau
Address: Avenida Sidónio Pais, n.º 51, Edif. “China Plaza”, 1.º andar, Macau (Receipt and Dispatch Unit)
Mondays to Thursdays: 09:00-13:00; 14:30-17:45
Fridays: 09:00-13:00; 14:30-17:30
Closed on Saturdays, Sundays and public holidays
（Subject to an additional 10% stamp duty）
Note: According to paragraph 2 of article 9 of Decree-Law no. 59/90/M dated 19th September, “No refund will be made if the initial registration is rejected or if the renewal is not approved after review.”
Application Processing Time
The application will be processed within 2 months upon receipt of all required documents.
Remarks/ Notes to Application
Without a review application, the medicine registration will become invalid after expiry date.
Application Status Enquiry and Result Collection
Method of result collection: In person
Content provider: Pharmaceutical Administration Bureau (ISAF)
Last modified: 2022-01-01 10:36