Approval and Issuance of Certificate of “Good Manufacturing Practice for Pharmaceutical Products (GMP)”

Application for “Good Manufacturing Practice for Pharmaceutical Products (GMP)”


How to Apply

Time of application: N/A

Application procedures and documents required

  1. A duly completed IFM-3 “Certificate of Good Manufacturing Practice for Pharmaceutical Products (GMP) ” application form;
  2. In the case of application in the name of a legal person (corporation), the original of a valid Business Registration Certificate of the Industrial Licence holder, issued by the Commerce and Movable Property Registry (Companies registered with the Commerce and Movable Property Registry are exempted from submitting this document.);
  3. Relevant documents of the applicant (if applying in the name of an individual) or the executive management members legitimately representing the Industrial Licence holder (if applying in the name of a legal person (corporation)):
    1. Certified true copy of the Macao Resident Identity Card or other identification documents bearing the signature, or present the original of the said identification documents (for verification and certification by the Pharmaceutical Affairs Department of the Health Bureau);
    2. Original of the Certificate of Criminal Record issued by the Identification Services Bureau (usage of the certificate: obtain licence for engagement in profession or activity relating to pharmaceuticals, can be applied at the Identification Services Bureau (DSI), via self-service kiosks or the DSI website; the Certificate issued by DSI will be delivered to the Health Bureau.);
  4. Certified true copy of the “Industrial Licence” and “Licence for Industrial Unit” (if applicable) issued by the Economic Services, or present the original of the said documents (for verification and certification by the Pharmaceutical Affairs Department of the Health Bureau);
  5. Photocopy of the “Licence for Pharmaceutical Production” issued by the Health Bureau;
  6. Photocopy of the “Certificate of Good Manufacturing Practice for Pharmaceutical Products (GMP)” issued by the Health Bureau (if applicable);
  7. Staff organization structure of the pharmaceutical manufacturing plant and placement of key technical personnel including technical supervisors, persons in charge of production and persons in charge of quality control:
    1. If applying in the name of a legal person (corporation), the organization structure should be signed by the executive management members legitimately representing the Industrial Licence holder and the technical supervisor, with specification of the effective date; if applying in the name of an individual, the organization structure should be signed by the holder of the Industrial Licence and the technical supervisor, with specification of the effective date;
    2. Key technical personnel should not be placed in such a way that overlaps with or serves in multiple capacities concurrently.
  8. Relevant documents of the key technical personnel of the pharmaceutical manufacturing plant:
    1. Certified true copy of the academic qualification documents, or present the original of the said documents (for verification and certification by the Pharmaceutical Affairs Department of the Health Bureau));
    2. Description of work experience;
    3. Description of relevant professional training;
    4. Assessment report on the capacity of key technical personnel by the management of the pharmaceutical manufacturing plant.
  9. Declaration of Responsibility (5) by the technical supervisor(s) (available at the location of application or on the Health Bureau website);
  10. Certified true copy of the proof of legal employment of the staff of the pharmaceutical manufacturing plant, including all personnel involved in the production and quality control procedures, or present the original of the said documents (for verification and certification by the Pharmaceutical Affairs Department of the Health Bureau);
  11. Site master file (Please refer to the ““Guidance for Compilation of Site Master File”);
  12. Other supporting documents and information relating to the application.

Location of Application and Service Hours

Location of application: Pharmaceutical Affairs Department, 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

N/A


Application Processing Time

Performance Pledge: The GMP certificate will be issued within 40 working days after all application documents are submitted and the premises concerned have passed site inspection.


Relevant Specifications or Requirements

  1. “General Guidelines on Pharmaceutical Production”
  2. “ Technical Guidelines on Hygiene in Pharmaceutical Industry”

Application Status Enquiry and Result Collection

Method of result collection: In person


Content provider: Health Bureau (SS)

Last modified: 2018-07-11 16:14

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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.