How to Apply
Time of application: Before applying for the import licence for raw materials of pharmaceuticals, 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” or local pharmaceutical manufacturers holding the “Licence for Pharmaceutical Production” issued by the Health Bureau.
Application procedures and documents required:
- In order for raw materials of pharmaceuticals to be authorised for import, the applicant should submit a batch analysis report of the pharmaceutical raw materials concerned, the content of which should conform to pharmacopoeia or corporate standards;
- A relevant “prior authorisation”[pdf][doc] 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
Law no. 7/2003 – Foreign Trade Law
Chief Executive Dispatch no. 487/2016 – List of Goods Authorised for Importation
Application Status Enquiry and Result Collection
Method of result collection: In person