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 Pharmaceutical Administration Bureau.
Eligibility: Companies holding the licence for “firms for import, export and wholesale of pharmaceutical products” issued by the Pharmaceutical Administration 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 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 Pharmaceutical Administration Bureau at least 3 working days prior to the application for import of human blood products.
- A relevant “prior authorisation” [doc][pdf] must be completed for each import application.
Location of Application and Service Hours
Location of application: Pharmaceutical Administration Bureau
Address: Avenida do Comendador Ho Yin, Edifício de Escritórios do Governo (Qingmao), 19.º andar, Macau
Service hours:
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
Fees
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