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

Relocation Application of Firm for Import, Export and Wholesale of Pharmaceutical Products


How to Apply

Time of application: Advance application to the Health Bureau is required for relocation of any firm for import, export and wholesale of pharmaceutical products.

Application procedures and documents required:

  1. A duly completed FI-3 Relocation Application Form for “Firm for Import, Export and Wholesale of Pharmaceutical Products”;
  2. The original building utilization permit issued by the Land, Public Works and Transport Bureau (DSSOPT) or the original Property Registration Report issued by the Real Estate Registry (Premises registered with the Real Estate Registry are exempted from submitting this document, Note 1);
  3. Design plan of the firm for import, export and wholesale of pharmaceutical products, including at least the following compartments, furniture and equipment (Notes 2 and 3):
    1. Compartments (Notes 4 and 5):
      1. Medicine storage;
      2. Compartments for administrative purposes;
      3. Lavatory;
    2. Furniture and equipment (Note 5):
      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.
  4. The below documents shall be submitted if the firm holds an authorisation to wholesale, import and export narcotic drugs and psychotropic substances:
    1. A written declaration shall be submitted if applying to maintain the said authorisation without replacing the staff responsible for compiling and keeping records of the relevant medicines;
    2. The PN-3 Application for Change of Staff Compiling and Keeping Records of Narcotic Drugs and Psychotropic Substances (for Firm for Import, Export and Wholesale of Pharmaceutical Products Only) shall be submitted along with a written declaration, if applying to maintain the said authorisation with any change in the said staff.
  5. Photocopy of the Business Tax Declaration Form (M/1 format) obtained from the Financial Services Bureau (Note 6).

Notes:

  1. The usage of the premise should be indicated as ‘commercial’, ‘factory’ or ‘industrial’;
  2. The design plan of the premise shall be signed by the applicant, or an executive management member legitimately representing the applicant when the applicant is a legal person;
  3. 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’;
  4. 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;
  5. If the firm holds an authorisation to wholesale, import and export narcotic drugs and psychotropic substances, it must be designed with an area for receipt and distribution of the said medicines, as well as a locked area for storing the relevant medicines (compartments, cabinets or refrigerators with locks);
  6. 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 300 (Note)

(Subject to 10% stamp duty; full amount payable upon submission of the application.)

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 19 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.


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: Not available online

Means of result collection: In person


Content provider: Health Bureau (SS)

Last modified: 2018-03-21 12:29

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