Pharmacy Licence

Pharmacy Relocation Application


How to Apply

Time of application:Advance application to the Health Bureau is required for pharmacy relocation.

Application procedures and documents required:

  1.  A duly completed FA-3 ‘Pharmacy’ Relocation Application Form;
  2.  Supporting document for the cause of the relocation;
  3.  The original building utilization permit issued by the Land, Public Works and Transport Bureau (DSSOPT) 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 1);
  4.  The design plan of the pharmacy, which should at least include 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.  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 installed in the medication dispensing room or reception room, medicine storage and office for administrative purposes).
  5.  Statement of the opening hours of the pharmacy and the staff technicians’ working hours after its relocation (Notes 4-6), with the following information included at the minimum:
    1.  Pharmacy opening hours from Monday to Sunday and on public holidays;
    2.  Working hours of the technical supervisor(s) and the substitute in the absence of the technical supervisor(s) from Monday to Sunday and on public holidays (Notes 7 and 8).
  6.  The below documents shall be submitted if the pharmacy holds an authorisation for the sale of narcotic drugs and psychotropic substances:
    1.  A written declaration shall be submitted if applying to maintain the said authorisation without replacing the staff responsible for compiling and keeping records of the relevant medicines;
    2.  The PN-4 Application for Change of Staff Compiling and Keeping Records of Narcotic Drugs and Psychotropic Substances (for Pharmacies Only) shall be submitted along with a written declaration, if applying to maintain the said authorisation with any change in the said staff.
  7.  Certified true copy of the identification documents of other pharmacy staff working after the relocation (or present the original ID for verification and certification by the Pharmaceutical Affairs Department of the Health Bureau);
  8.  Photocopy of the Business Tax Declaration Form (M/1 format) obtained from the Financial Services Bureau (Note 9).

Notes:

  1.  The usage of the premise should be indicated as ‘commercial’;
  2. 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;
  3.  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’;
  4.  FA-5 Application for Change of ‘Pharmacy’ Technical Supervisor shall also be submitted if there is any change in the supervisor(s).
  5.  FA-6 Application for Change of Substitute in the Absence of ‘Pharmacy’ Technical Supervisors shall also be submitted if there is any change in the substitute.
  6.  Statement of the opening hours of the pharmacy and the staff technicians’ working hours shall be jointly signed by the applicant (or an executive management member legitimately representing the applicant when the applicant is a legal person), the technical supervisor(s) and the substitute acting in their absence;
  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;
  9.  Can be submitted before the issuance of the licence.

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

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 19 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

A pharmacy may be relocated to another location under the circumstances listed below, according to the provisions in Paragraph 1 of Article 44 under Decree-Law No. 58/90/M dated 19th September:

  1.  The building housing the pharmacy is demolished or acquired;
  2.  The facilities of the pharmacy or the building in which the pharmacy is partially located become dilapidated and unable to provide suitable conditions for its operation.

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 12:26

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All information on this site is based on the official language of the Macao Special Administrative Region. The English version is the translation from the Chinese originals and is provided for reference only. If you find that some of the contents do not have an English version, please refer to the Traditional Chinese or Portuguese versions.