How to Apply
Time of application: Before applying for the import licence for pharmaceutical 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:
In order for the medicines to be authorised for import, the following documents and information must be submitted in advance:
- Original or certified true copy of the registration certificate issued by the competent authority in the country of origin or the country of export; alternatively, a notarized copy by the notary department in Macao, or a notarized copy by a Chinese consulate in the country of issue after translation of the certificate into Chinese; original documents presented will be verified by the Pharmaceutical Administration Bureau.
- Original or certified true copy of the production licence or an equivalent document issued by the competent authority in the country of origin, while “the equivalent document must specify the name of the product and its manufacturer”; alternatively, a notarized copy by the notary department in Macao, or a notarized copy by a Chinese consulate in the country of issue after translation of the licence/document into Chinese; original documents presented will be verified by the Pharmaceutical Administration Bureau.
- In addition to the aforementioned documents required for the application, the manufacturer or market authorisation holder of the drug must also present an authorisation document for authorising the distribution of the drug through the relevant “firms for import, export and wholesale of pharmaceutical products” in Macau;
- The master formula, stability study, detailed method of analysis and certificate of analysis issued by the manufacturers or market authorization holder.
- Sample outer package;
- Package insert;
- Depending on the category of pharmaceutical product to be imported, a relevant “prior authorisation” must be completed for each import application:
- Prior authorisation for import of medicines (western medicines)[pdf][doc]
- Prior authorisation for import of veterinary drugs[pdf][doc]
- Prior authorisation for import of narcotic drugs[pdf][doc]
- Prior authorisation for import of psychotropic substances[pdf][doc]
- Prior authorisation for import of drugs containing codeine[pdf][doc]
- Prior authorisation for import of drugs containing dextromethorphan[pdf][doc]
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
A notice of submission of supplementary documents for new drug application will be issued within 3 working days. (Performance Pledge)
The prior authorisation will be issued in 3 working days upon receipt of all required documents. (Performance Pledge)
Remarks/ Notes to Application
- The abovementioned documents and information must be submitted to the Pharmaceutical Administration Bureau 15 days in advance of the initial application of prior authorisation for the relevant pharmaceutical product; all documents and information submitted will be filed and kept in strict confidence.
- For the import of narcotic drugs or psychotropic substances, an import certificate must be prepared in advance for the concerned drugs/substances; please refer to the <Certificate of Import and Export of Narcotic Drugs and Psychotropic Substances> webpage.
- For the import of vaccines, there are further documents to be submitted; please refer to the <Prior Authorisation for Import of Vaccines> webpage.
- The importation of human blood products is subject to the provisions in the Dispatch of Health Bureau Director no. 47/SS/2009; please refer to the <Prior Authorisation for Import of Human Blood Products> webpage.
- The importation of new drugs is subject to the provisions in the Dispatch of Health Bureau Director no. 04/SS/2021.
Relevant Specifications or Requirements
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
Technical Instruction of the Health Bureau no. 01/2005 – Labelling Requirements on the Packaging of Radiopharmaceutical Products
Technical Instruction of the Health Bureau no. 02/2001 – Regulations on the Import of Pharmaceutical Products Containing Bovine-Derived Substances
Dispatch of Health Bureau Director no. 04/SS/2016 – Documents Required for Import of New Drugs
Application Status Enquiry and Result Collection
Method of result collection: In person