Import of Goods (Health Bureau)

Prior Authorisation for Import of Chinese Proprietary Medicines and Traditional Medicines


How to Apply

Time of application: Before applying for the import licence for Chinese proprietary medicines and traditional medicines, the applicant must first obtain the relevant prior authorisation for import from the Health Bureau.

Eligibility: Companies holding the licence for “firms for import, export and wholesale of pharmaceutical products” issued by the Health Bureau.

Application procedures and documents required:

  1. The importer is required to submit the following documents 3 working days prior to importation: the original or certified true copy of the registration certificate issued by the competent authority in the place of origin or exporting country/region. If the country/region does not have a registration system in place, a test report of heavy metals content and a surveillance report of microbial limits should be submitted;
  2. A completed “Prior Authorisation for Import of Chinese Proprietary Medicines and Traditional Medicines” [pdf][doc]must be submitted for each importation;
  3. Sample outer package;
  4. Package insert.

Location of Application and Service Hours

Location of application: Department of Pharmaceutical Affairs of the Health 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

The prior authorisation will be issued in 3 working days upon receipt of all required documents. (Performance Pledge)


Relevant Specifications or Requirements

Technical Instruction of the Health Bureau no. 01/2004 – Standard Microbial Limit in Chinese Propriety Medicine and Traditional Medicine

Technical Instruction of the Health Bureau no. 04/2005 – Labelling Requirements on the Packaging of Chinese Propriety Medicine and Traditional Medicine

Dispatch of Health Bureau Director no. 10/SS/2013 – Standard for Heavy Metal Contents in Chinese Proprietary Medicine and Traditional Medicine for Oral or Topical Use


Application Status Enquiry and Result Collection

Method of result collection: In person


Content provider: Health Bureau (SS)

Last modified: 2018-03-21 12:48

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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.