Approval and Issuance of “Licence for Pharmaceutical Production”

Application for “Licence for Pharmaceutical Production”


How to Apply

Time of application: N/A

Application procedures and documents required

  1. A duly completed IFM-1 “Licence for Pharmaceutical Production” 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” 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 (if applicable);
  6. 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.
  7. 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.
  8. Declaration of Responsibility (5) by the technical supervisor(s);
  9. 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);
  10. Documents and information involved in the application of “Licence for Pharmaceutical Production”:
    1. Floor plan and construction standards of the production sites;
    2. Description and test reports of the manufacturing facilities and equipment;
    3. Environmental standards and surveillance report of the production sites;
    4. Description and test reports of the quality control facilities and equipment;
    5. Design plan, operation standards and test reports of the air-conditioning system, temperature and humidity control system and other auxiliary systems;
    6. Design plan, operation standards and test reports of the process water treatment and supply system;
    7. List of pharmaceutical production (including production formula, volume of production, technical process of production, name of product and dose form), as well as the proposed production and sales plan;
    8. Material procurement and quality control management;
    9. Records and table of contents of the standard operating protocol;
    10. If applicable, the arrangement of commissioned production as well as the arrangement of on-site supervision on the commissioned production activities;
    11. If applicable, the arrangement of commissioned inspection.
  11. Other supporting documents and information relating to the application.

Remarks:

The floor plan mentioned in 10.1 of the “Application procedures and documents required” should specify the dimensions and scale, and with indication of personnel flow and material flow. A floor plan typically includes rooms or physically isolated areas for the following activities:

  1.  Delivery and receipt;
  2.  Storage of satisfactory, inspection pending and unsatisfactory materials and finished products;
  3.  Separate routes for personnel flow and material flow;
  4.  Changing room;
  5.  Production;
  6.  Inner packaging;
  7.  Outer packaging;
  8.  Weighing of raw materials;
  9.  Weighing of finished products;
  10. Intermediate control;
  11. Storage of semi-finished products;
  12. Storage of waste materials;
  13. Separate cleaning and storage of production instruments;
  14. Cleaning and storage of cleansing equipment of the premises;
  15. Staff hygiene;
  16. Administration;
  17. Quality control;
  18. Installations of auxiliary facilities and equipment;
  19. Other activities related to pharmaceutical production.

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 licence will be issued within 30 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 16:10

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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.