Application for “Authorisation for Import, Export and Wholesale/Sale of Narcotic Drugs and Psychotropic Substances”

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How to Apply

Time of application: N/A

Application procedures and documents required

1. A duly completed PN-1 Application Form for Authorisation for Distribution, Import and Export of Narcotic Drugs and Psychotropic Substances (For Firm for Import, Export and Wholesale of Pharmaceutical Products Only) ;
2. Relevant documents of the owner of the firm for import, export and wholesale of pharmaceutical products (or its manager(s), administrator(s) or director(s) in the case of the owner being a 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: 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.);
   3. Letter of employment of the staff compiling and keeping records of narcotic drugs and psychotropic substances, issued by the owner of the firm for import, export and wholesale of pharmaceutical products (the letter of employment must contain the name of the employee, the start date and employment position):
      1. The letter of employment should be signed by the owner if the owner is an individual;
      2. The letter of employment should be signed by an executive management member legitimately representing the company when the owner is a legal person.
3. Relevant documents of the staff compiling and keeping records of narcotic drugs and psychotropic substances:
   1. Certified true copy of the Macao Resident Identity Card, or present the original (for verification and certification by the Inspection and Licensing Department of Pharmaceutical Administration Bureau);
   2. Original of the Certificate of Criminal Record issued by the Identification Services Bureau (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.);
   3. Photocopy of the licence for pharmacist/pharmacy assistant technician registered with Pharmaceutical Administration Bureau;
   4. P&NDeclaration of P&N Responsibility (1) ;
   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.
4. Updated design plan of the firm for import, export and wholesale of pharmaceutical products signed by the applicant (or by an executive management member legitimately representing the company when the applicant is a legal person), including at least the following safety facilities:
   1. An area for receipt and distribution of the narcotic drugs and psychotropic substances;
   2. A locked area for storing narcotic drugs and psychotropic substances (compartments, cabinets or refrigerators with locks).

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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 10,000, subject to 10% stamp duty.

1. 50% of the licensing fee must be paid upon submission of the application, and the rest should be paid within 15 days after the related party receives notification of the approval dispatch.
2. ‘The fees paid will not be returned if the application is rejected or filed,’ according to Paragraph 4 of Article 54 of Decree-Law No. 34/99/M dated 19 July.

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Application Processing Time

An authorisation will be issued within 45 working days after all required documents are submitted and the premise concerned has passed the site inspection. (Performance Pledge)

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Remarks/Notes for Application

1. “Pharmaceutical premises” refer to businesses that are licensed or authorised by Pharmaceutical Administration Bureau to engage in pharmaceutical activities, including pharmaceutical manufacturing plants, firms for import, export and wholesale of pharmaceutical products, pharmacies and medicine stores;
2. Please refer to the requirements for plan specifications and premise establishment indicated in “Pharmaceutical Businesses – Establishment and Renovation Guidelines”.

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Application Status Enquiry and Result Collection

Method of result collection: In person

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