Issuance of Certificate of Sale of Locally Manufactured Chinese Proprietary Medicines

Application


How to Apply

Time of application: Before the Chinese proprietary medicines and traditional medicines produced by local manufacturers can be put on the Macao market, an application of prior authorisation for the local sale of such products must be made to the Health Bureau on a batch basis.

Eligibility: Companies holding the licence for “firms for import, export and wholesale of pharmaceutical products”

Application procedures and documents required:

  1. A duly completed application form of “Prior Authorisation for the local sale of Chinese proprietary medicines and traditional Medicines”;
  2. The test report of heavy metals content and the test report of microbial limits of each batch;
  3. Sample of inner and outer packages;
  4. Package insert.

Location of Application and Service Hours

Location of application: Pharmaceutical Affairs Department 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 for local sale of proprietary Chinese medicines and traditional medicines will be issued in 10 working days after the applicant has submitted all required documents. (Performance pledge)


Collection of Application Result

Method of result collection: In person


Content provider: Health Bureau (SS)

Last modified: 2018-03-21 12:50

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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.