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 Pharmaceutical Administration 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” or “License to manufacture products used in traditional Chinese medicine” issued by the Pharmaceutical Administration 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”[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)
The import license will be issued on the same day. (Performance Pledge)
Remarks/ Notes to Application
If the products to be imported contain dangerous substances, the UN number or CAS number of the said substances must be provided under the product name column of the Prior Authorisation form.
Relevant Specifications or Requirements
Law no. 7/2003 – Foreign Trade Law
Law no. 12/2022 – Legal regime for the control of dangerous substances
Administrative Regulation no. 27/2023 – Main regulation of the legal regime for the control of dangerous substances
Chief Executive Dispatch no. 209/2021 – List of Goods Authorised for Importation
Chief Executive Dispatch no. 107/2023 – Defines the subcategorization and enumeration of hazardous substances
Application Status Enquiry and Result Collection
Method of result collection: In person