Licence for Firm for Import, Export and Wholesale of Pharmaceutical Products

Licence for Firm for Import, Export and Wholesale of Pharmaceutical Products – Application


How to Apply

Time of application: N/A

Application procedures and documents required

  • Application in the name of a legal person (corporation):
  1. A duly completed FI-1 Licence Application Form for “Firm for Import, Export and Wholesale of Pharmaceutical Products” (Corporation);
  2. Original of the legal person’s Business Registration Certificate 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 manager(s), administrator(s) or director(s) of the legal person:
    1. Certified true copy of 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 under 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. Design plan of the firm for import, export and wholesale of pharmaceutical products, including at least the following compartments, furniture and equipment (Notes 1 and 2):
    1. Compartments:
      1. Medicine storage (Note 3);
      2. Compartments for administrative purposes;
      3. Lavatory;
    2. Furniture and equipment:
      1. Appropriate air-conditioning system;
      2. Refrigerating facilities with adequate capacity to store products that require cold storage;
      3. Should there be flammable products, the specific conditions for storing such products.
  5. Original of the building utilization permit issued by the Land, Public Works and Transport Bureau (DSSOPT) or the Property Registration Report issued by the Real Estate Registry (Premises registered with the Real Estate Registry are exempted from submitting this document, Note 4);
  6. Photocopy of the Business Tax Declaration Form from the Financial Services Bureau (M/1 format) (Note 5);
  • Application in the name of an individual:
  1. A duly completed FI-2 Licence Application Form for “Firm for Import, Export and Wholesale of Pharmaceutical Products” (Individual);
  2. Relevant documents of the applicant:
    1. Certified true copy of Macao Resident Identity Card, or present the original (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.);
  3. Refer to Points 4-6 mentioned in the previous section.

Notes:

  1. The layout plan of the premise should be signed by the applicant, or the executive management member legitimately representing the company when the applicant is a legal person;
  2. Please refer to the requirements for plan specifications and premise establishment indicated in ‘Pharmaceutical Businesses – Procedures of Licensing Application and Alteration Works Plan Submission, and Technical Guidelines’;
  3. Compartments used for storage of pharmaceutical products shall not be accessible to the public, and must be separated from other compartments, in particular those intended for administrative purposes;
  4. The usage of the premise should be indicated as ‘commercial’, “factory” or “industrial”;
  5. Can be submitted before the issuance of the licence.

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

MOP 3,000 (Note)
(Subject to 10% stamp duty. 50% of the licensing fee must be paid when submitting the application, and the rest should be paid within 15 days after the related party receives notification of the authorisation for premise establishment.)

Note: The fees paid will not be returned if the application is rejected or filed,’ according to Paragraph 5 of Article 21 of Decree-Law No. 58/90/M dated 19th September.


Application Processing Time

The Health Bureau will finish the review and approval process within 90 days upon receipt of all the documents required, and will issue an authorisation for premise establishment in the case of approval. The time needed for licence issuance depends on the progress of premise establishment and the processes of statutory inspection.

Performance pledge: The licence will be issued within 35 workings days after all application documents are submitted and the premise concerned has passed the inspection.


Relevant Specifications or Requirements

Read more:
Pharmaceutical Businesses – Procedures of Licensing Application and Alteration Works Plan Submission, and Technical Guidelines


Application Status Enquiry and Result Collection

Application status enquiry: Please check the application status via the Macao Government Service Mobile Application or the Macao SAR Government Portal (the applicant has to apply for an Online Account for Public Service in advance).

Method of result collection: In person


Content provider: Health Bureau (SS)

Last modified: 2018-03-21 12:29

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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.