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Pharmacy Licence

Application for transfer of ownership of Pharmacy


How to Apply

The first stage:Application for Declaration on Obtaining Entitlement to Pharmacy Ownership Transfer

Time of application: N/A

Application procedures and documents required:

  • Legal person (corporation) as the subject to obtain pharmacy ownership transfer:
  1. The completed FA-11 Application Form for Declaration on Obtaining Entitlement to ‘Pharmacy’ Ownership Transfer (Notes 1-5);
  2. Relevant documents required from the subject of pharmacy ownership transfer:
    1. 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.);
    2. Relevant documents required from its manager(s), administrator(s) or director(s):
      1. Certified true copy of Macao Resident Identity Card or other identification documents bearing their 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 Conflict (1).
  • Individual as the subject to obtain pharmacy ownership transfer:
  1. The completed FA-11 Application Form for Declaration on Obtaining Entitlement to ‘Pharmacy’ Ownership Transfer (Notes 1-5);
  2. Relevant documents required from the subject of pharmacy ownership transfer:
    1. Certified true copy of Macao SAR 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 Pharmaceutical Administration Bureau.);
    3. Declaration of Absence of Conflict (1).

Notes:

  1. According to Paragraph 5 of Article 58 under Decree-Law no. 58/90/M dated 19th September, where the subject to obtain the pharmacy ownership transfer is not a pharmacist, or the company being acquired has no pharmacist among its members, the transfer can only be carried out when technical guidance of the pharmacy is assured.
  2. According to Paragraph 1 of Article 62 under Decree-Law no. 58/90/M dated 19th September, no deed or contract for the transfer of pharmacy ownership and the assignment of operating rights or of the shares of the pharmacy-owning company shall be concluded, unless the ‘Declaration on Obtaining Entitlement to Pharmacy Ownership Transfer’ issued by Pharmaceutical Administration Bureau is presented to the notary.
  3. According to Paragraph 2 of Article 62 under Decree-Law no.58/90/M dated 19th September, the acquirer or assignee of pharmacy operating rights shall apply to Pharmaceutical Administration Bureau for registration within 30 days after the act of acquisition or assignment. The applicant should complete and submit the FA-4 Application Form for Registration of ‘Pharmacy’ Ownership Transfer with a copy of the relevant deed or licence for annotation purposes.
  4. The completed application form, together with the documents required, shall be submitted directly or delivered by double-registered mail to the Inspection and Licensing Department under Pharmaceutical Administration Bureau;
  5. In the case of pharmacy ownership transfer resulting from death, the application shall be carried out by the heir(s) by submitting the proof of legitimate inheritance.

 

The second stage:Application for Registration of Pharmacy Ownership Transfer

Time of application: According to Paragraph 2 of Article 62 under Decree-Law no.58/90/M dated 19th September, the acquirer or assignee of pharmacy operating rights shall apply to Pharmaceutical Administration Bureau for registration within 30 days after the act of acquisition or assignment, and submit a copy of the relevant deed or licence for annotation purposes.

Application procedures and documents required:

  • Legal person (corporation) as the subject to obtain pharmacy ownership transfer:
  1. The completed FA-4 Application Form for Registration of ‘Pharmacy’ Ownership Transfer;
  2. Photocopy of ‘Declaration on Obtaining Entitlement to Pharmacy Ownership Transfer’ issued by Pharmaceutical Administration Bureau;
  3. Deed or contract of pharmacy ownership transferred from the current owner to the new owner (Notes 1-3);
  4. Relevant documents of the new owner:
    1. 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.);
    2. Certified true copy of the Macao Resident Identity Card or other identification documents of the manager(s), administrator(s) or director(s) of the legal person bearing their signature, or present the original of the said identification documents (for verification and certification by the Inspection and Licensing Department of Pharmaceutical Administration Bureau).
  5. Relevant documents of the pharmacy technical supervisor(s) (Note 4):
    1. Certified true copy of the 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 5).
  6. Relevant documents of the substitute in the absence of pharmacy technical supervisor(s) (Note 4):
    1. Certified true copy of the 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. Declaration of Absence of Conflict (2) for pharmacists / Declaration of Absence of Conflict (3) for pharmacy assistant technicians;
    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 5).
  7. 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 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).
  8. Certified true copy of identification documents of the other pharmacy staff, or present the original (for verification and certification by the Inspection and Licensing Department of Pharmaceutical Administration Bureau);
  9. The new owner shall submit the relevant documents under the following situations if the pharmacy holds an authorisation for trade of narcotic drugs and psychotropic substances:
    1. The new owner shall submit the following documents if applying to maintain the said authorisation without replacing the staff responsible for compiling and keeping records of the relevant medicines:
      1. Written declaration signed by the new owner (Note 9);
      2. Original of the new owner’s Certificate of Criminal Record (usage of the certificate: to apply for 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.) (Note 10);
      3. Declaration of P&N Responsibility (2).
    2. The new owner shall submit the following documents if applying to maintain the said authorisation and replacing the staff responsible for compiling and keeping records of the relevant medicines:
      1. Written declaration signed by the new owner (Note 9);
      2. Original of the new owner’s Certificate of Criminal Record (usage of the certificate: to apply for 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.) (Note 10);
      3. The PN-4 Application for Change of Staff Compiling and Keeping Records of Narcotic Drugs and Psychotropic Substances (for Pharmacies Only).
  10. Photocopy of the Business Tax Declaration Form (M/1 format) obtained from the Financial Services Bureau (Note 11).
  • Individual as the subject to obtain pharmacy ownership transfer:
  1. The completed FA-4 Application Form for Registration of ‘Pharmacy’ Ownership Transfer;
  2. Photocopy of ‘Declaration on Obtaining Entitlement to Pharmacy Ownership Transfer’ issued by Pharmaceutical Administration Bureau;
  3. Deed or contract of pharmacy ownership transferred from the current owner to the new owner (Notes 1-3);
  4. Certified true copy of the new owner’s Macao Resident Identity Card, or present the original (for verification and certification by the Inspection and Licensing Department of Pharmaceutical Administration Bureau).
  5. Same documents as stated in Items 5-10 of the previous section.

Notes:

  1. According to Paragraph 1 of Article 62 under Decree-Law no. 58/90/M dated 19th September, no deed or contract for the transfer of pharmacy ownership and the assignment of operating rights or of the shares of the pharmacy-owning company shall be concluded, unless the ‘Declaration on Obtaining Entitlement to Pharmacy Ownership Transfer’ issued by Pharmaceutical Administration Bureau is presented to the notary. The said Declaration can be applied for with the completed FA-11 Application Form for Declaration on Obtaining Entitlement to ‘Pharmacy’ Ownership Transfer;
  2. According to Paragraph 2 of Article 62 under Decree-Law no.58/90/M dated 19th September, the acquirer or assignee of pharmacy operating rights shall apply to Pharmaceutical Administration Bureau for registration within 30 days after the act of acquisition or assignment, and submit a copy of the relevant deed or licence for annotation purposes;
  3. In the case of pharmacy ownership transfer resulting from death, the proof of legitimate inheritance shall be submitted.
  4. According to Paragraph 5 of Article 58 under Decree-Law no. 58/90/M dated 19th September, where the subject to obtain the pharmacy ownership transfer is not a pharmacist, or the company being acquired has no pharmacist among its members, the transfer can only be carried out when technical guidance of the pharmacy is assured.
  5. ‘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;
  6. Statement of the opening hours of the pharmacy and the staff technicians’ working hours shall be jointly signed by the new owner (or an executive management member legitimately representing the company when the new owner 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. The declaration shall be signed by an executive management member legitimately representing the company when the new owner is a legal person;
  10. The original Certificate of Criminal Record of the manager(s), administrator(s) or director(s) shall be submitted when the new owner is a legal person;
  11. The Business Tax Declaration Form copy may be submitted before licence issuance. 

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


Fees

Not required.


Application Processing Time

  1. Application for Declaration on Obtaining Entitlement to Pharmacy Ownership Transfer:Pharmaceutical Administration Bureau will finish the review and approval process within 15 days upon receipt of all the documents required.
  2. Application for Registration of Pharmacy Ownership Transfer:Pharmaceutical Administration Bureau will finish the review and approval process within 90 days upon receipt of all the documents required.

Remarks/Notes for Application

  1. According to Articles 58 to 61 of Decree-Law no. 58/90/M dated 19th September, the subject to obtain pharmacy ownership transfer shall meet the following requirements:
    • Residing or being based in Macao, and be constituted in accordance with law if the applicant is a legal person;
    • Not engaging in any activity that involves provision of medical services, particularly doctors or related professions;
    • Possessing the appropriate civil qualification for engaging in pharmaceutical activities;
    • Ensuring technical guidance for the pharmacy in accordance with law;
    • Ensuring the personnel that will work in the pharmacy possesses the qualifications that are required by law for performing related duties;
    • Ensuring the facilities and equipment of the pharmacy fulfil the appropriate conditions stipulated in the law and other legislation on safety, sanitation and hygiene of commercial premises.
  2. According to the provisions of Paragraphs 1 and 2 of Article 62 under Decree-Law no. 58/90/M dated 19th September:
    • The pharmacy owner shall present to the Notary Office the ‘Declaration on Obtaining Entitlement to Pharmacy Ownership Transfer’ issued by Pharmaceutical Administration Bureau in order to conclude any deed or contract for the transfer of pharmacy ownership, and the assignment of operating rights or of the shares of the pharmacy-owning company;
    • The acquirer or assignee of pharmacy operating rights shall apply to Pharmaceutical Administration Bureau for registration within 30 days after the act of acquisition or assignment, and submit a copy of the relevant deed or licence for annotation purposes;

Application Status Enquiry and Result Collection

Application status enquiry:Not available online

Means of result collection:In person


Content provider: Pharmaceutical Administration Bureau (ISAF)

Last modified: 2024-07-27 12:22

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