Frequently asked questions
- After a western medicine is successfully approved in Macao, how long will the registration be valid for?
- How long does it take for the application of registration of western medicines to be reviewed and approved?
- Where can I find the information about the medicines registered with the Pharmaceutical Administration Bureau?
- What are the channels for enquiry about suspended or recalled medicines?
- What is the “Lists of Registered Medicines in Macao SAR (Listas de Medicamentos existentes no Mercado na RAEM)”? Where can I obtain it?
1. After a western medicine is successfully approved in Macao, how long will the registration be valid for?
After a western medicine is successfully approved in Macao, the initial registration will be valid for 2 years and is renewable consecutively for a 5-year term each, upon review (renewal) application by a related party.
2. How long does it take for the application of registration of western medicines to be reviewed and approved?
The time required for application review and approval varies on a case-by-case basis. Generally, the application will be handed to the Medicine Registration Technical Committee for their review within five months upon receipt of all application documents. Given the opinion of the Committee, the Pharmaceutical Administration Bureau will notify the applicant of the application result, or request the applicant to make amendments or provide supplementary information for application review.
3. Where can I find the information about the medicines registered with the Pharmaceutical Administration Bureau?
The relevant information has been uploaded to the Pharmaceutical Administration Bureau website.
4. What are the channels for enquiry about suspended or recalled medicines?
For enquiries, please visit the Pharmaceutical Administration Bureau website or contact the Pharmaceutical Administration Bureau at (853) 8598 3203 during office hours.
5. What is the “Lists of Registered Medicines in Macao SAR (Listas de Medicamentos existentes no Mercado na RAEM)”? Where can I obtain it?
The “Lists of Registered Medicines in Macao SAR (Listas de Medicamentos existentes no Mercado na RAEM)” is a collection of the lists of western medicines, Chinese proprietary medicines and natural medicines authorised for import in Macao in a particular year. It provides information such as the trade name, dosage form, treatment and classification, route of administration, active ingredients and content of the medicines. The “Lists” are made available in CD form to local pharmaceutical businesses and health professionals.
Collection method:
1. For firms for import, export and wholesale of pharmaceutical products, pharmaceutical manufacturing plants, pharmacies, medicine stores, Chinese medicine pharmacies, pharmacists, traditional Chinese medicine pharmacists and pharmacy technicians:
Place of collection: Pharmaceutical Administration Bureau (Avenida Sidónio Pais, n.º 51, Edif. “China Plaza”, 1.º andar, Macau
Enquiry telephone: (853) 8598 3524
2. For dentists, practitioners of Western and Chinese medicine
Place of collection: Medical Activity Licensing Unit (Alameda Dr. Carlos D’ Assumpção, Nos. 335-341, Edifício Centro Hotline, 6º andar, Macau)
Enquiry telephone: (853) 2871 3734
Fees: Free of charge
In addition, information of the medicines will be updated on a regular basis. The latest information of registered medicines can be found on the Pharmaceutical Administration Bureau website.