Application for Information Change of Licence Holder of Firm for Import, Export and Wholesale of Pharmaceutical Products

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How to Apply

Time of application: Advance application shall be submitted to Pharmaceutical Administration Bureau for any change in the information related to the licence holder of a firm for import, export and wholesale of pharmaceutical products (individual / legal person).

Application procedures and documents required:

• Documents required to apply for a name change of the legal person holding a licence of firm for import, export and wholesale of pharmaceutical products (Note):

1. The completed FI-8 Application Form for Information Change of Licence Holder of ‘Firm for Import, Export and Wholesale of Pharmaceutical Products’ (Individual / Legal Person);
2. 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.);
3. Photocopy of the Business Tax Declaration Form obtained from the Financial Services Bureau (M/1 format)

• Documents required to apply for an address change of the individual / legal person holding a licence of firm for import, export and wholesale of pharmaceutical products:

1. The completed FI-8 Application Form for Information Change of Licence Holder of ‘Firm for Import, Export and Wholesale of Pharmaceutical Products’ (Individual / Legal Person);
2. Photocopy of the Business Tax Declaration Form obtained from the Financial Services Bureau (M/1 format);
3. The original Business Registration Certificate of the holder issued by the Commerce and Movable Property Registry when the holder is a legal person (Companies registered with the Commerce and Movable Property Registry are exempted from submitting this document.).

• Documents required to apply for a change in executive management members of the legal person holding a licence of firm for import, export and wholesale of pharmaceutical products:

1. The completed FI-8 Application Form for Information Change of Licence Holder of ‘Firm for Import, Export and Wholesale of Pharmaceutical Products’ (Individual / Legal Person);
2. 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.);
3. When the change involves addition of executive management members to the legal person, the following documents of the new executive management member(s) should be submitted:
   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 Inspection and Licensing Department of Pharmaceutical Administration Bureau);
   2. Original 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 Pharmaceutical Administration Bureau.);
   3. The member(s)’ original Certificate of Criminal Record issued by the Identification Services Bureau shall also be submitted if the firm holds the authorisation to trade narcotic drugs and psychotropic substances (usage of the certificate: to apply for the 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 Pharmaceutical Administration Bureau.).

• Documents required to apply for a change in the signature of the legal person holding a licence of firm for import, export and wholesale of pharmaceutical products:

1. The completed FI-8 Application Form for Information Change of Licence Holder of ‘Firm for Import, Export and Wholesale of Pharmaceutical Products’ (Individual / Legal Person);
2. 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.);

Note: The Business Registration Number of the licensee remains unchanged.

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Location of Application and Service Hours

Location of application: Inspection and Licensing Department, Pharmaceutical Administration 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

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Fees

Not required

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Application Processing Time

Pharmaceutical Administration Bureau will finish the review and approval process within 90 days upon receipt of all the documents required.

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Application Status Enquiry and Result Collection

Application status enquiry: Not available online

Means of result collection: In person

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