Pharmacy Licence Application

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How to Apply

Time of application: N/A

Application procedures and documents required:

• Application in the name of a legal person (corporation):

1.  A duly completed FA-1 ‘Pharmacy’ Licence Application Form (Corporations);(Click here to start the online application service)
2.  Original of the legal person’s Business Registration Certificate issued by the Commerce and Movable Property Registry(Companies registered with the Commerce and Movable Property Registry are exempted from submitting this document.);
3.  Relevant documents of the manager(s), administrator(s) or director(s) of the legal person:
   1.  Certified true copy of 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 under Pharmaceutical Administration Bureau);
   2. Original of the Certificate of Criminal Record issued by the Identification Services Bureau (usage of the certificate: 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.  Declaration of Absence of Conflicts (1).
4.  Relevant documents of the pharmacy technical supervisor(s):
   1.  Certified true copy of Macao Resident Identity Card, or present the original (for verification and certification by the Inspection and Licensing Department under Pharmaceutical Administration Bureau);
   2.  Photocopy of the licence for pharmacist registered with Pharmaceutical Administration Bureau;
   3.  Declaration of Responsibility (1);
   4.  Declaration of Absence of Conflict (2);
   5.  Declaration of resignation from the pharmaceutical premise or other institution previously served, with the name of the premise or institution concerned and the date of employment termination. In the event of not having served any pharmaceutical premise or other institution, please state in the declaration (Note 1).
5.  Relevant documents of the substitute in the absence of pharmacy technical supervisor(s):
   1.  Certified true copy of Macao Resident Identity Card, or present the original (for verification and certification by the Inspection and Licensing Department under Pharmaceutical Administration Bureau);
   2.  Photocopy of the licence for pharmacist/pharmacy assistant technician registered with Pharmaceutical Administration Bureau;
   3.  Declaration of Responsibility (2)
   4.  Pharmacist: Declaration of Absence of Conflict (2) / Pharmacy assistant technician: Declaration of Absence of Conflict (3);
   5.  Declaration of resignation from the pharmaceutical premise or other institution previously served, with the name of the premise or institution concerned and the date of employment termination. In the event of not having served any pharmaceutical premise or other institution, please state in the declaration (Note 1).
6.  Certified true copies of the identification documents of other staff at the pharmacy, or present the originals (for verification and certification by the Inspection and Licensing Department under Pharmaceutical Administration Bureau);
7.  Design plan of the pharmacy, including at least the following compartments, furniture and equipment (Notes 2 and 3):
   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 cabinets 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.  Cabinets for storing materials;
      5.  Refrigerators 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 installed in the medication dispensing room or reception room, medicine storage and the office for administrative purposes).
8.  Original of the building utilization permit issued by the Land and Urban Construction Bureau (DSSCU) and the Property Registration Report issued by the Real Estate Registry (Premises registered with the Real Estate Registry are exempted from submitting this document, Note 4);
9.  Photocopy of the Business Tax Declaration Form from the Financial Services Bureau (M/1 format) (Note 5);
10.  Statement of the opening hours of the pharmacy and the staff technicians’ working hours (Note 6), including at least the following information:
    1.  Pharmacy opening hours from Monday to Sunday including public holidays;
    2.  Working hours of the technical supervisor(s) and the substitute in the absence of technical supervisors from Monday to Sunday including public holidays (Notes 7 and 8).

• Application in the name of an individual:

1.  A duly completed FA-2 ‘Pharmacy’ Licence Application Form (Individual);(Click here to start the online application service)
2.  Relevant documents of the applicant:
   1.  Certified true copy of Macao Resident Identity Card, or present the original (for verification and certification by the Inspection and Licensing Department under Pharmaceutical Administration Bureau);
   2.  Original of the Certificate of Criminal Record issued by the Identification Services Bureau (usage of the certificate: 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.);
   3.  Declaration of Absence of Conflict (1).
3.  Refer to Points 4-10 mentioned in the previous section.

Notes:

1.  ‘Pharmaceutical premises’ refer to businesses that are licensed and authorised by Pharmaceutical Administration Bureau to engage in pharmaceutical activities, including pharmaceutical factories, firms for import, export and wholesale of pharmaceutical products, pharmacies and medicine stores;
2.  The layout plan of the premise should be signed by the applicant, or the executive management member legitimately representing the company when the applicant is a legal person;
3. 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.
4.  The usage of the premise should be indicated as ‘commercial’;
5.  Can be submitted before the issuance of the licence;
6. The statement of the opening hours of the pharmacy and the staff technicians’ working hours must be signed jointly by the applicant (or the executive management member legitimately representing the company in case the applicant is a legal person), technical supervisor(s) and the substitute in the absence of the technical supervisor(s);
7.  Articles 33 and 34 of Decree-Law No. 58/99/M dated 19th September must be followed;
8.  Law No. 7/2008 Labour Relations Law must be followed.

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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 2,000 (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.

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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.

Performance pledge: The licence will be issued within 35 workings days after all application documents are submitted and the premise concerned has passed the inspection.

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Relevant Specifications or 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: Please check the application status via the Macao Government Service Mobile Application or the Macao SAR Government Portal (the applicant has to apply for an Online Account for Public Service in advance).

Method of result collection:In person

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