How to Apply
Time of application: Before applying for the import licence for human blood products, the applicant must first obtain the relevant prior authorisation for import from the Health Bureau.
Eligibility: Companies holding the licence for “firms for import, export and wholesale of pharmaceutical products” issued by the Health Bureau.
Application procedures and documents required:
- Before importing human blood products, firms for import, export and wholesale of pharmaceutical products must, in addition to submitting in advance the documents listed in Technical Instruction of the Health Bureau no. 02/2000, hand in the original or certified copy of the following documents:
- Batch certificate issued by the manufacturer containing the following information:
- All blood donors must be tested negative for anti-HIV-1 Ab and anti-HIV-2 Ab, HBsAg and anti-HCV Ab;
- The plasma pool (collection of plasma) must be tested negative for anti-HIV-1 Ab and anti-HIV-2 Ab, HBsAg and anti-HCV Ab;
- The product has been processed with “Cohn Oncley” cold ethanol fractionation, heat treatment (continuous heating at 60°C for 10 hours) or other proven viral inactivation procedures.
- The Certificate of Good Manufacturing Practice for Pharmaceutical Products (GMP) of the manufacturer.
- The above documents should be submitted to the Department of Pharmaceutical Affairs at least 3 working days prior to the application for import of human blood products.
- A relevant “prior authorisation” must be completed for each import application.
Location of Application and Service Hours
Location of application: Department of Pharmaceutical Affairs of the Health 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
Free of charge
Application Processing Time
The prior authorisation will be issued in 3 working days upon receipt of all required documents. (Performance Pledge)
Relevant Specifications or Requirements
Dispatch of Health Bureau Director no. 47/SS/2009 – Documents Required for Import Licensing of Human Blood Products
Technical Instruction of the Health Bureau no. 02/2000 – Documents Required for Import Licensing of Pharmaceutical Products
Technical Instruction of the Health Bureau no. 03/2005 – Labelling Requirements on the Packaging of Western Medicines
Application Status Enquiry and Result Collection
Method of result collection: In person