Application for Registration of Medicines (Western Medicines)

Renewal


How to Apply:

Time of application:

According to paragraph 2 of article 8 of Decree-Law no. 59/90/M dated 19th September, “The review application should be lodged three months before the registration expiry date”.

Application procedures and documents required:

  1. Manufacturer’s statement, together with any test report or change of information (if applicable); the statement shall include the following
    1. Report of the lack of efficacy or public safety risk during the marketing of the medicine (if any);
    2. If there is any change to the volume and packaging of the medicine;
    3. If there is any change to the formula and production method of the medicine.
  2. The latest quality analysis report of the medicine;
  3. The latest report on the long-term stability of the medicine;
  4. Other necessary documents or information requested by the Health Bureau.

Location of Application and Service Hours

Location of application: Department of Pharmaceutical Affairs, 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

MOP 750.【Note】

(Subject to an additional 10% stamp duty)

Note: According to paragraph 2 of article 9 of Decree-Law no. 59/90/M dated 19th September, “No refund will be made if the initial registration is rejected or if the renewal is not approved after review.”


Application Processing Time

The application will be processed within 2 months upon receipt of all required documents.


Remarks/ Notes to Application

Without a review application, the medicine registration will become invalid after expiry date.


Application Status Enquiry and Result Collection

Method of result collection: In person


Content provider: Health Bureau (SS)

Last modified: 2018-03-21 12:47

Entrepreneurship and business Product, article supervision

Is there anything wrong with this page?

Help us improve GOV.MO

* Mandatory field

Send

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.