Import of Goods (Pharmaceutical Administration Bureau)

1. What kind of prior authorisations for import does the Pharmaceutical Administration Bureau issue?

The Pharmaceutical Administration Bureau issues prior authorisation for import for the following goods:

1. Pharmaceutical products (including western medicines, vaccines and human blood products);
2. Chinese proprietary medicines and natural medicines;
3. Chinese Medicinal Ingredients, Prepared Portions and Extracts;
4. Raw materials of pharmaceuticals;
5. Modified milk for infant feeding (i.e. infant formula milk powder);
6. Diagnostic and laboratory reagents;
7. Paramedical products;
8. General chemicals (including insecticides).

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2. What kind of goods does the electronic import licensing service apply to?

The electronic import licensing service is applicable to the following goods:

1. Pharmaceutical products (western medicine, excluding vaccines and human blood products);
2. Chinese proprietary medicines and natural medicines;
3. Modified milk for infant feeding (i.e. infant formula milk powder);
4. Diagnostic and laboratory reagents (excluding reagents containing insecticides or pesticides).

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3. How much is the application fee of the prior authorisation for import? How long does the application process take?

All applications of prior authorisation for import are free of charge. It takes 3 working days to process the application upon receipt of all required documents.

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4. How long is the prior authorisation for import valid for? How about the import licence?

The prior authorisation for import is valid for 90 days from the day of issue, while the import licence is valid for 30 days from the day of issue.

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5. How to apply for import license? How long does the import license application take?

Applicant should obtain a completed import license from Pharmaceutical Administration Bureau on or before the day of product importation.

To apply for import license, applicant should submit the following documents:

1. The original copy of prior authorisation form issued by the Pharmaceutical Administration Bureau;
2. A completed “Import License (Form I)”[available for purchase at the Printing Bureau or the Government Information Center].

Upon receipt of the above documents, the Pharmaceutical Administration Bureau should issue the import license on the day of application.

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6. Is it possible to transfer the prior authorisation for import or the import licence?

No, prior authorisations for import and import licences are non-transferable.

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7. What drugs are banned in Macao?

The following drugs have been banned in Macao; for more details, please visit the Pharmaceutical Administration Bureau website (www.isaf.gov.mo):

• Chlormezanone (Date: 27/01/1997)
• Fenfluramine and Dexfenfluramine (Date: 10/11/1997)
• Trovafloxacin and Alatrofloxacin (Date: 26/07/1999)
• Amfepramone, Phentermine, Clobenzorex, Fenproporex, Mefenorex, Norpseudoefedrine (Cathine) and Phendimetrazine (Date: 29/11/1999)
• Appetite suppressants containing Phenylpropanomamine (Date: 19/03/2001)
• Nimesulide paediatric preparation (Date: 16/04/2001)
• Chinese herbs Caulis Aristolochiae Manshuriensis (Guanmutong), Radix Aristolochiae Fangchi (Guangfangji), Radix Aristolochiae (Qingmuxiang) and their pharmaceutical preparations (Date:08/10/2004)
• Pharmaceutical products containing bovine-derived substances from affected areas of bovine spongiform encephalopathy (Date:26/04/2005)
  • Note I: The above regulation does not apply to the pharmaceutical products of which the importation or production is authorised by the Health Bureau Director in one of the following situations:
    • (1)  Where an emergency occurs, considering the interests of public health and the absence of an alternative; or
    • (2)   Where the pharmaceutical product complies with the recommendations of World Health Organization or other equivalent requirements to minimize the risk of transmission of spongiform encephalopathies;
    • Bovine-derived materials which, pursuant to the World Health Organization guidelines on transmissible spongiform encephalopathies in relation to pharmaceutical products, are classified as tissues with no potential infectivity for spongiform encephalopathies, such as bones, skin, tendons and milk of cattle.
  • Note II: In the manufacture of pharmaceutical products, it is prohibited to use bovine-derived materials of any geographic source that, pursuant to the World Health Organization guidelines on transmissible spongiform encephalopathies in relation to pharmaceutical products, are classified as tissues with high potential infectivity for spongiform encephalopathies, such as brain, spinal cord, retina, optic nerve, spinal ganglia, trigeminal ganglia, pituitary gland and dura mater.
• Sibutramine (excluding medicines or raw materials intended for use in laboratory research or as reference standards) (Date:25/01/2011)
• Dextropropoxyphene (excluding medicines or raw materials intended for use in laboratory research or as reference standards) (Date:21/03/2011)
• The importation of any medicinal products containing both corticosteroids and non-steroidal anti-inflammatory drugs. (Date: 08/24/2015)

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