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Import of Goods (Pharmaceutical Administration Bureau)

Prior Authorisation for Import of Chinese Proprietary Medicines and Natural Medicines


How to Apply

Time of application: Before applying for the import licence for Chinese proprietary medicines and natural medicines, 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 ” “License for import, export and wholesale of products used in traditional Chinese medicine” issued by the Pharmaceutical Administration Bureau.

Application procedures and documents required: A completed “Prior Authorisation for Import of Chinese Proprietary Medicines and Natural Medicines” [pdf][doc]must be submitted for each importation.


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)


Relevant Specifications or Requirements

Law no. 11/2021 – Law on Pharmaceutical activities in the field of traditional Chinese medicine and registration of traditional Chinese medicines

Administrative Regulation No. 46/2021 – Regulation of the Law on Pharmaceutical activities in the field of traditional Chinese medicine and registration of traditional Chinese medicines

Technical Instruction of the Pharmaceutical Administration Bureau no  23/ISAF/2022 – Standard Specification for Heavy Metals and Toxic Elements, Microbiological Limits and Pesticide Residue Limits in Proprietary Chinese Medicines

Technical Instruction of the Pharmaceutical Administration Bureau no  24/ISAF/2022 –  Regulations for the registration of proprietary Chinese medicines with bovine origin


Application Status Enquiry and Result Collection

Method of result collection: In person


Content provider: Pharmaceutical Administration Bureau (ISAF)

Last modified: 2024-07-11 10:53

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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.