Facility Alteration Application of Firm for Import, Export and Wholesale of Pharmaceutical Products

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How to Apply

Time of application: Advance application to Pharmaceutical Administration Bureau is required for any alteration of the facilities at the firm for import, export and wholesale of pharmaceutical products.

Application procedures and documents required:

1. The completed FI-7 Facility Alteration Application Form for ‘Firm for Import, Export and Wholesale of Pharmaceutical Products’;
2. Design plan of the firm for import, export and wholesale of pharmaceutical products following intended alteration, which should at least include the following compartments, furniture and equipment (Notes 1 and 2):
   1. Compartments (Notes 3 and 4):
      1. Medicine storage
      2. Compartments for administrative purposes;
      3. Lavatory.
   2. Furniture and equipment (Note 4):
      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.
3. If the intended alteration involves expansion of the premise, the firm shall submit the following documents for the extension:
   1. Building utilisation permit issued by the Land and Urban Construction Bureau 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 5);
   2. Photocopy of the updated Business Tax Declaration Form (M/1 format) obtained from the Financial Services Bureau (Note 6).
4. If the intended alteration involves downsizing of the premise, the firm shall submit a photocopy of the updated Business Tax Declaration Form (M/1 format) obtained from the Financial Services Bureau (Note 6).

Notes:

1. The plan of the premise shall be signed by the applicant, or an executive management member legitimately representing the company when the applicant is a legal person;
2. M5-Pedido de aprovação do projecto (de alteração) da obra de modificação (Uso exclusivo para estabelecimento de actividade farmacêutica) on the website of the Land and Urban Construction Bureau for the specifications of the site plans and requirements of the site installation;
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. 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);
5. The extension of the premise should be for ‘commercial’, ‘factory’ or ‘industrial’ purposes;
6. Can be submitted before the licence issuance.

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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

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 19th September.

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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, 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.

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Relevant Specifications and Requirements

Read more:
M5-Pedido de aprovação do projecto (de alteração) da obra de modificação (Uso exclusivo para estabelecimento de actividade farmacêutica) on the website of the Land and Urban Construction Bureau for the specifications of the site plans and requirements of the site installation

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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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