Pharmacy Facility Alteration Application

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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 pharmacy.

Application procedures and documents required:

1.  The completed FA-9 ‘Pharmacy’ Facility Alteration Application Form;
2.  Design plan of the pharmacy following intended alteration, which should at least include the following compartments, furniture and equipment (Notes 1 and 2):
   1. Compartments:
      1.  Medication dispensing room or reception room;
      2.  Medicine storage;
      3.  Office for administrative purposes;
      4.  Lavatory;
      5.  Laboratory.
   2.  Furniture and equipment:
      1.  Glass cabinet for storing medicines for sale in the medication dispensing room;
      2.  Closed cabinets or safe for storing narcotic drugs, psychotropic drugs and other toxic or dangerous goods (which must be placed inside the medication dispensing room/reception room or medicine storage);
      3.  Reception desk;
      4.  Cabinet for storing materials;
      5.  Refrigerator for storing medicines that require cold storage;
      6.  Closed cabinets for the pharmacy staff to keep clothes;
      7.  Air ventilation and air conditioning systems (which must be placed inside the medication dispensing room or reception room, medicine storage and the office for administrative purposes).
3.  If the intended alteration involves expansion of the pharmacy premise, the pharmacy 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 3);
   2.  Photocopy of the updated Business Tax Declaration Form (M/1 format) obtained from the Financial Services Bureau (Note 4).
4.  If the intended alteration involves downsizing of the pharmacy premise, the pharmacy shall submit a photocopy of the updated Business Tax Declaration Form (M/1 format) obtained from the Financial Services Bureau (Note 4).

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.  The extension of the premise should be for ‘commercial’ use;
4.  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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