e-form

Application for a Variation to a Licence issued in accordance with the
Production of Cannabis for Medicinal and Research Purposes Act
(Chapter 578 of the Laws of Malta)

Licence holder name:

Licence holder address:

Site Name/ Number:

Street:

Locality:

Postcode:

Number of Licence being varied:

Contact name:

Telephone number:

Mobile number:

E-mail address:

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LICENCE IN ACCORDANCE WITH THE PRODUCTION OF CANNABIS FOR MEDICINAL AND RESEARCH PURPOSES ACT (Chapter 578 of the Laws of Malta)

PLEASE TICK ACCORDINGLY

A1 Change in details of the licence holder

A2 Change in details related to the products manufactured (Section 6.9 of Application for Licence)

A3 Addition to currently approved operations

A4 Deletion of currently approved operations

A5 Addition of a testing Contract Laboratory

A6 Removal of a testing Contract Laboratory

A7 Addition of Qualified Person

A8 Removal of Qualified Person

A9 Addition of Person Responsible for Production

A10 Removal of Person Responsible for Production

A11 Addition of Person Responsible for Quality Control

A12 Removal of Person Responsible for Quality Control

A13 Change in MMA Declaration Form for Due Diligence Procedures (Annex 2 of Application for Licence)

A14 Other: (please specify)

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Specify the precise present and proposed wording, highlighting the changes.

PRESENT

PROPOSED

Please give a brief background explanation for the proposed change(s) to your licence.

I hereby make an application for the above licence for the Production of Cannabis for Medicinal and Research Purposes to be varied in accordance with the proposal(s) given above and certify that the change(s) will not adversely affect any cannabis product produced on the premises. I declare that the supporting information supplied is correct and shall submit to the Medicines Authority any additional information/documents requested. I declare that all changes have been identified and that there are no other changes in the amended documentation.

*Licence Holder Signature:

Kindly fill in the Declaration of the form at the following link http://www.medicinesauthority.gov.mt/onlineapplications. A Declaration form should be submitted for each signatory.

Status (Job Title):

Name & Surname:

Date:

* In case of a company, the legal & judicial representative of the company. Please submit a copy of a recent Memorandum & Articles of Association issued by MFSA in support of this.

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