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Import of Goods (Pharmaceutical Administration Bureau)

Prior Authorisation for Import of Medicines (Western Medicines)


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:

  1. 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.
  2. 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.
  3. 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;
  4. The master formula, stability study, detailed method of analysis and certificate of analysis issued by the manufacturers or market authorization holder.
  5. Sample outer package;
  6. Package insert;
  7. Depending on the category of pharmaceutical product to be imported, a relevant “prior authorisation” must be completed for each import application:
    1. Prior authorisation for import of medicines (western medicines)[pdf][doc]
    2. Prior authorisation for import of veterinary drugs[pdf][doc]
    3. Prior authorisation for import of narcotic drugs[pdf][doc]
    4. Prior authorisation for import of psychotropic substances[pdf][doc]
    5. Prior authorisation for import of drugs containing codeine[pdf][doc]
    6. Prior authorisation for import of drugs containing dextromethorphan[pdf][doc]

Location of Application and Service Hours

Location of application: Pharmaceutical Administration Bureau

Address: Avenida Sidónio Pais, n.º 51, Edif. “China Plaza”, 1.º andar, Macau (Receipt and Dispatch Unit)

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


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


Content provider: Pharmaceutical Administration Bureau (ISAF)

Last modified: 2022-01-01 13:20

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All information on this site is based on the official language of the Macao Special Administrative Region. The English version is the translation from the Chinese originals and is provided for reference only. If you find that some of the contents do not have an English version, please refer to the Traditional Chinese or Portuguese versions.