Application for a Licence in accordance with the Production of Cannabis for Medicinal and Research Purposes Act (Cap. 578 of the Laws of Malta)
Application Type (PLEASE TICK ONE):
1 DETAILS OF THE PROPOSED LICENCE HOLDER
If not applicable insert N/A in each box
Company registration number:
Legal and judicial representative of company:
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CAN002/03 Appendix 1 Version 1
2 LEGAL ADDRESS OF PROPOSED LICENCE HOLDER
If an individual- address on ID card.
If a company- address registered with MFSA.
3 DETAILS OF PROPOSED LICENCE HOLDER CONTACT
3.2 Address of licence holder contact if different from section 2
If not applicable insert N/A in each box
3.3 Telephone number:
Mobile Number:
Email Address:
CAN002/03 Appendix 1 Version 1
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4 DETAILS RELATED TO DUE DILIGENCE
Required for all company shareholders, ultimate beneficial owners (UBOs) (direct or indirect), directors, management, responsible officers, qualified person and any other person with a financial interest and persons with decision making powers of influence.
Name:
Surname:
Date of Birth:
ID number:
Passport number:
Position held in the company:
Building Name/ No:
Street:
Locality:
Postcode:
Country:
Contact number:
Email:
Print and fill in additional copies of this section as necessary. Attach a notarised copy of Identity card or passport and MMA Declaration Form for Due Diligence Procedures (Annex 2). The applicant/ licence holder commits to provide updated documentation for consideration by the regulatory authority should any changes related to the above come into effect or changes/ additions with respect to parties (persons/companies) related to the operations being licensed are proposed. Failure to comply with this shall be considered a significant breach and may lead to withdrawal of licence.
Number of copies attached:
CAN002/03 Appendix 1 Version 1
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5.1 Address of proposed site:
Building Name/ No.:
Street:
Locality:
Postcode:
5.2 Site contact (if different from section 3):
If not applicable insert N/A in each box
Name:
Surname:
Telephone number:
Mobile number:
Email Address:
CAN002/03 Appendix 1 Version 1
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6. MANUFACTURING FOR MEDICINAL AND RESEARCH PURPOSES
QUALIFIED PERSON
Name:
Surname:
Pharmacy Council QP Registration Number:
Pharmacy Council Pharmacist Registration Number:
Home telephone number:
Office telephone number:
Mobile number:
E-mail address:
Position held with the company other than Qualified Person (QP), if any:
Type of employment with the company:
Experience related to the activities to be performed under the licence and how this has been acquired:
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I accept to take up the responsibility of QP as described in the Medicines Act (Cap. 458) where applicable. I confirm that the above particulars are to the best of my knowledge and belief accurate and true.
Signed (proposed QP):
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.
Date:
Signed (proposed Licence holder):
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.
Print and fill in additional copies of this section as necessary, if more than 1 QP is nominated by licence holder.
Number of copies attached:
PERSON WITH OVERALL RESPONSIBILITY FOR PRODUCTION
Name:
Home telephone number:
Office telephone number:
Mobile number:
Email address:
Experience in GMP related areas:
Details of the person(s) to whom he/she reports:
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PERSON WITH OVERALL RESPONSIBILITY FOR QUALITY CONTROL
Home telephone number:
Office telephone number:
Mobile number:
Email address:
Experience in GMP related areas:
Details of the person(s) to whom he/she reports:
A. Cultivation of Cannabis
Tick the activities to be held at the site:
6.2.1 Type and strains of seeds or cuttings:
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The following must be completed per product (for each form and strength):
Product name:
Dosage form:
Weight/volume of finished product:
% CBD and % THC of finished product:
Starting material description:
% CBD and % THC of starting material:
Estimated annual weight/volume of starting material required:
Estimated annual weight/volume of imported starting material (if applicable):
Estimated annual number of finished products to be released:
Estimated annual weight/volume of finished products to be released:
Print and fill in additional copies of this section as necessary.
Number of copies attached:
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D. Contracted out activities
Applicant is contract giver (i.e. uses external test houses for some/all testing):
Name of proposed laboratory:
Site Address of proposed laboratory:
Building Name/No.:
Street:
Poscode:
Country:
Testing activities at this site:
Print and fill in additional copies of this section as necessary and attach a copy of EU-GMP certificate of the proposed contractor.
Number of copies attached:
E. Destruction and/or disposal of cannabis
Please specify the proposed method for destruction/disposal:
Add clarifying remarks related to the scope of these manufacturing operations:
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Please note that products intended for use in clinical trials also require EU-GMP certification (refer to previous sections).
PERSONS WITH OVERALL RESPONSIBILITY FOR RESEARCH:
Home telephone no.:
Office telephone no.:
Mobile no.:
E-mail address:
Experience in GMP related areas
Details of the person(s) to whom he/she reports
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A. Cultivation of cannabis for research purposes
Tick the activities to be held at the site:
7.2.1 Types and strains of seeds or cuttings:
B. Sourcing of cannabis for research purposes
Tick activities to be held at the site:
7.3 Company/sponsor/individual responsible for purchasing/sourcing cannabis for research purposes:
Specify form, source and estimated annual quantities (including % THC and CBD):
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PROPOSED LICENSE HOLDER'S DECLARATION
This application is intended for the granting of a Licence, in accordance with the Production of Cannabis for Medicinal and Research Purposes Act (Chapter. 578 of the Laws of Malta) to the proposed holder named in this application form in respect of the activities to which the application refers, in relation to cannabis for medicinal and/or research purposes only.
1. The applicant commits to comply with Maltese legislation, and the Courts of Malta shall have exclusive jurisdiction to settle any claim, difference, or dispute which may arise out of or in connection with the applicant’s/licence holder’s operations. The applicant/license holder irrevocably waives any claim that such action or proceeding has been brought in an inconvenient forum or that the Courts of Malta do not have jurisdiction.
2. The applicant is familiar with and will comply with the provisions of the Production of Cannabis for Medicinal and Research Purposes Act (Chapter 578 of the Laws of Malta), regulations and guidelines, that may be amended from time to time, as applicable to the licence.
3. In the interest of protecting public health and the prevention of the illicit diversion of cannabis, the applicant authorises the regulatory authority to carry out due diligence, know-your-client (KYC), and any other procedures or evaluation permitted under Maltese law, on company shareholders, ultimate beneficial owners (UBOs), directors, officers, and employees, including the company’s history, source of funds, business operations, commercial associations and affiliations, medical screening and ethical conduct.
4. The applicant is informed and understands that notwithstanding the granting of any licence, permit, or authorisation granted by the Licensing Authority, the Commissioner of Police may, in line with Article 5(3) of The Production of Cannabis for Medicinal and Research Purposes Act (Chapter 578 of the Laws of Malta), take reasonable action necessary to investigate, prevent and prosecute any crime carried out or is expected/suspected to be carried out on the premises where any activity authorised under mentioned Act is taking place.
5. The applicant attests that the suspension, withdrawal, revocation, cancellation or expiry of the licence and/or the letter of intent for any reason, shall preclude the applicant from carrying out any activity related to cannabis.
6. The applicant hereby authorises the regulatory authority to furnish the Malta Police Force, Customs Officials, International Narcotics Control Board and any other local or foreign authority with any information and documentation if requested.
7. All operations are to be carried out only in accordance with the information set out in the application or furnished in connection therewith. The applicant commits to provide updated documentation, which may include details of specifications, methods of analysis, import/export estimates and comprehensive reports, as may be periodically requested by the regulatory authority.
8. The applicant declares that he holds the relevant product licences, or equivalent, relating to any products the applicant intends to manufacture and/or assemble pursuant to this application.
9. The applicant attests that all the information and documents submitted in support of the application are, to the best of his knowledge, correct and complete. (If other than applicant, a power of attorney from proposed licence holder nominating and authorising signatory to apply on his behalf is required).
Signed:
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.
Surname:
Name:
ID/Passport No.:
Date:
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ANNEX 1: DOCUMENTS TO BE ATTACHED TO APPLICATION
1. Manufacturing process
2. Source(s) of starting/raw material to be used in manufacture
3. Copy of EU-GMP certificate and/or QP audit report for source(s), as applicable
4. Copy of EU-GMP certificate for contractor(s), as applicable
5. Labelling and any product information (in English) available for the final product, including information on the pack of the product
6. Specifications of the starting/raw material, stability studies, certificate of analysis, including compendia, methods and ranges or limits, details of manufacturing process, including radioactivity analysis and declaration of pesticides used, as applicable
7. Specifications of the final products, stability studies, certificate of analysis, including compendia, methods and ranges or limits
8. Procedures in place for reporting, including adverse reaction reports and recalls
9. Specifications, technical drawings and certificate(s) of compliance from supplier(s) for packaging of products to be released from the local facility
10. Research proposal, as applicable
B. MANUFACTURING FACILITY
1. Site Master File in line with EU-GMP guidelines requirements
2. ERA Permits for unlicensed sites listed on application, as applicable
3. Floor plan of the site and building, building site plans and location survey, as applicable
4. Architect's report, as applicable
5. Name and contact information of the project’s supervisor (if the building is under construction)
6. Proposed operational hours of the facility
7. Environmental, waste management and sanitation plan and signed copy(ies) of waste disposal agreement(s), as applicable
8. Facility security documentation; site plan indicating: entrances and exits (including emergency exits); and locations of - access control system, CCTV, CCTV control room, security personnel, physical security policy, physical security risk assessment, policies and procedures related to physical entry controls, policies and procedures related to delivery and loading areas controls, policies and procedures for stock-taking, process flow chart showing the incoming, processing and outgoing of products, SOP/policies for unauthorised access, theft and emergency procedures as applicable to transportation including responsibility, record keeping and reconciliation, audit report of outsourced transport activities and signed copy of agreement(s) (as applicable)
1. Curriculum vitae of Production Manager
2. Curriculum vitae of Quality Control Manager
3. Curriculum vitae of Qualified Person
4. Copy of Pharmacy Council QP certificate and copy of Pharmacy Council Pharmacist warrant of Qualified Person(s)
5. Organisation chart
6. Certificate of Registration issued by MFSA (for private & public companies)
7. Memorandum and articles of association
8. Malta Enterprise Letter of Intent
9. Notarised identity card/passport copies (as per Section 4) and MMA Declaration Form for Due Diligence Procedures (Annex 2)
10. Declaration of Source of Funds Form (Annex 3)
11. Power of attorney to sign on behalf of the licence holder (if applicable)
12. Proof of Payment
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CAN002/03 Appendix 1 Version 1
ANNEX 2: MALTA MEDICINES AUTHORITY DECLARATION FORM FOR DUE DILIGENCE PROCEDURES
Please complete the table below for all the Shareholders, Ultimate Beneficial Owners (direct or indirect), Directors, Managers, Qualified Person(s), Responsible Officers and any other persons with a financial interest and persons with decision making powers of influence of proposed Licence Holder.
ID Card Number/Passport Number
Print and fill in additional copies of this section as necessary
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CAN002/3 Appendix 1 Version 1
I, the applicant for a Licence in accordance with the Production of Cannabis for Medicinal and Research Purposes Act (Cap. 578 of the Laws of Malta), hereby declare that all the information given in the Due Diligence Declaration Form is true, complete and correct. I also hereby bind myself to inform Malta Medicines Authority immediately as soon as there are any changes to the information provided in the Due Diligence Declaration Form but in any case by no later than five (5) working days from such an occurrence.
Company Name:
Company Registration Number:
Name & Surname*:
Position:
Signature*
Date:
*Name, surname and signature have to be those of applicant.
I, the appointed auditor of
hereby certify that the information provided
in this declaration form is true, complete and correct.
Name & Surname:
Warrant Number:
Signature:
Date:
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CAN002/03 Appendix 1 Version 1
ANNEX 3: DECLARATION OF SOURCE OF FUNDS FORM
Malta Financial Services Authority (MFSA) and Financial Intelligence Analysis Unit (FIAU) guidelines require the Medicines Authority to obtain information on the source of funds of individual transactions. Information is therefore being collated in this form on the activity, event, business, occupation or employment from which the funds used in order to settle the fees for the application of a licence for the production of Cannabis for Medicinal and Research Purposes are generated.
In fulfilling its regulatory obligations, the Medicines Authority may require the applicant to support the information provided herein.
Ultimate Beneficial Owner's Name:
Personal Identification Number:
Full details of the activity, event, business, occupation or employment which generate the funds used for this transaction:
I hereby confirm that the above information is accurate and complete
Ultimate Beneficial Owner's Signature
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CAN002/03 Appendix 1 Version 1