How to Apply
Time of application: Before applying for the import licence for Chinese proprietary medicines and traditional medicines, 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:
- The importer is required to submit the following documents 3 working days prior to importation: the original or certified true copy of the registration certificate issued by the competent authority in the place of origin or exporting country/region. If the country/region does not have a registration system in place, a test report of heavy metals content and a surveillance report of microbial limits should be submitted;
- A completed “Prior Authorisation for Import of Chinese Proprietary Medicines and Traditional Medicines” [pdf][doc]must be submitted for each importation;
- Sample outer package;
- Package insert.
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
Technical Instruction of the Health Bureau no. 01/2004 – Standard Microbial Limit in Chinese Propriety Medicine and Traditional Medicine
Technical Instruction of the Health Bureau no. 04/2005 – Labelling Requirements on the Packaging of Chinese Propriety Medicine and Traditional Medicine
Dispatch of Health Bureau Director no. 10/SS/2013 – Standard for Heavy Metal Contents in Chinese Proprietary Medicine and Traditional Medicine for Oral or Topical Use
Application Status Enquiry and Result Collection
Method of result collection: In person