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

Application for Ownership Transfer 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 the ownership transfer of firms for import, export and wholesale of pharmaceutical products.

Application procedures and documents required:

  • If the transferee is a legal person (corporation):
  1. The completed FI-4 Application Form for Ownership Transfer of ‘Firm for Import, Export and Wholesale of Pharmaceutical Products’;
  2. A declaration jointly signed by the current owner and the new owner (with signatures verified by the notary department), which should include the following (Notes 1 and 2):
    1. The current owner declares closure of the firm, and the new owner declares opening of a new firm;
    2. The current owner declares to transfer the documents of his/her firm to that of the new owner, while the new owner declares to accept the transfer of relevant documents (if applicable).
  3. Relevant documents of the new owner:
    1. The original Business Registration Certificate of the legal person issued by the Commerce and Movable Property Registry (Companies registered with the Commerce and Movable Property Registry are exempted from submitting this document.);
    2. The following documents from the manager(s), administrator(s) or director(s):
      1. Certified true copy of the Macao Resident Identity Card or other identification documents bearing the signature, or present the original of the said 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: to 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 3 and 4):
    1. Compartments (Notes 5 and 6):
      1. Medicine storage;
      2. Compartments for administrative purposes;
      3. Lavatory;
    2. Furniture and equipment (Note 6):
      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 7);
  6. Photocopy of the Business Tax Declaration Form (M/1 format) obtained from the Financial Services Bureau (Note 8)
  7. The new owner shall submit the relevant documents under the following situations if the firm holds an authorisation for wholesale, import and export of narcotic drugs and psychotropic substances:
    1. The new owner shall submit the following documents if applying to maintain the said authorisation without replacing the staff responsible for compiling and keeping records of the relevant medicines:
      1. Written declaration signed by the new owner (Note 1);
      2. Original of the new owner’s Certificate of Criminal Record (usage of the certificate: to apply for authorisation to produce, trade and supply narcotic drugs and psychotropic substances, 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.) (Note 9);
      3. Declaration of P&N Responsibility (1).
    2. The new owner shall submit the following documents if applying to maintain the said authorisation and replacing the staff responsible for compiling and keeping records of the relevant medicines:
      1. Written declaration signed by the new owner (Note 1);
      2. Original of the new owner’s Certificate of Criminal Record (usage of the certificate: to apply for authorisation to produce, trade and supply narcotic drugs and psychotropic substances, 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.) (Note 9);
      3. 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).
  • If the transferee is an individual:
  1. The completed FI-4 Application Form for Ownership Transfer of ‘Firm for Import, Export and Wholesale of Pharmaceutical Products’;
  2. A declaration jointly signed by the current owner and the new owner (with signatures verified by the notary department), which should include the following (Note 1):
    1. The current owner declares closure of the firm, and the new owner declares opening of a new firm;
    2. The current owner declares to transfer the documents of his/her firm to that of the new owner, while the new owner declares to accept the transfer of relevant documents (if applicable).
  3. Relevant documents of the new owner:
    1. Certified true copy of the 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: to 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. Same documents as stated in Points 4-7 of the previous section.

Notes:

  1. The declaration shall be signed by an executive management member legitimately representing the company when the owner is a legal person;
  2. In the case of ownership transfer resulting from death, the application can be carried out by the heir(s). In this case, it is not necessary to submit the declaration, but the proof of legitimate inheritance will be required.
  3. 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;
  4. 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’;
  5. 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;
  6. 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);
  7. The usage of the premise should be indicated as ‘commercial’, ‘factory’ or ‘industrial’;
  8. Can be submitted before licence issuance;
  9. In the event of the firm owner being a legal person, the original Certificate of Criminal Record of its manager(s), administrator(s) or director(s) should be submitted.

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

MOP3,000 (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.


Remarks/Notes for Application

The subject to obtain ownership transfer of the firm for import, export and wholesale of pharmaceutical products shall:

  1. Reside or be based in Macao, and be constituted in accordance with law if the subject is a legal person;
  2. Possess the appropriate civil qualification for engaging in pharmaceutical activities; in the event of the subject being a legal person, its managers or director shall possess the appropriate civil qualification for engaging in pharmaceutical activities;
  3. Ensure that the firm is equipped with appropriate facilities that fulfil the safety and quality requirements for the preservation and storage of medicines.

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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