e-form

Application for a Variation to a Pharmacy Licence

SECTION A

Where applicable, please complete blank sections with the word ‘not applicable’.

1. Licence Holder Details:

1a If Individual:

Name:

Surname:

ID or passport number:

1b If Company:

Name:

Company registration number:

Legal and judicial representative of company:

Name:

Surname:

ID or passport number:

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2. Pharmacy Details:

Pharmacy Licence No.:

Name/No.:

Street:

Locality:

Postcode:

Telephone number:

Mobile number:

E-mail address:

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SECTION B

PROPOSED VARIATION:

1. Change in name and/or address of licence holder:

Details of present licence holder:

1a If Individual:

Name:

Surname:

ID or passport number:

Legal address of licence holder:

Name/ No.:

Street:

Locality:

Postcode:

1b If Company:

Name:

Company registration number:

Legal and judicial representative of company:

Name:

Surname:

ID or passport number:

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Legal address of licence holder:

Name/ No.:

Street:

Locality:

Postcode:

Details of proposed licence holder:

1c If Individual:

Name:

Surname:

ID or passport number:

Legal and judicial representative of company:

Name/ No.:

Street:

Locality:

Postcode:

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1d If Company:

Name:

Company registration number:

Legal and judicial representative of company:

Name:

Surname:

ID or passport number:

Legal address of legal and judicial representative of company:

Name/ No.:

Street:

Locality:

Postcode:

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1e Is proposed licence holder a medical practitioner, dental surgeon and/or veterinary surgeon?

Signature of present licence holder, or legal representative in case of company:

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

Date:

Signature of proposed licence holder, or legal representative in case of company:

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

Date:

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2. Change in name of the pharmacy:

2a Present pharmacy name:

2b Proposed pharmacy name:

3. Change in site of the pharmacy:

3a Present pharmacy address:

Name/ No.:

Street:

Locality:

Postcode:

3b Proposed pharmacy address:

Name/ No.:

Street:

Locality:

Postcode:

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4 Addition of store to the pharmacy licence:

4a Proposed store address:

Name/ No.:

Street:

Locality:

Postcode:

5 Change in managing pharmacist:

5a Details of present managing pharmacist:

Name:

Surname:

Initials:

Pharmacy Council Registration Number:

Telephone number:

Mobile number:

E-mail address:

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5b Details of proposed managing pharmacist:

Name:

Surname:

Initials:

Pharmacy Council Registration Number:

Telephone number:

Mobile number:

E-mail address:

Section C

Background (please give brief background explanation for the proposed changes to your licence).

I hereby make application for the above Pharmacy Licence to be varied in accordance with the proposals given above and certify that the changes will not adversely affect the quality, efficacy or safety of any medicinal product on the premises. I declare that amended documents have been supplied and that the supporting information is correct. 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 form at the following link http://www.medicinesauthority.gov.mt/onlineapplications
A Declaration form should be submitted for each signatory.

Print name:

Status (Job title):

Date:

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ANNEX A - DOCUMENTS TO BE ATTACHED WITH APPLICATION

In case of change to licence holder:

1 Police conduct certificate of proposed licence holder or in case of company, legal and judicial representative.

2 In case of company Original Memorandum and Articles of Company issued by MFSA.

In case of change to pharmacy site:

1 Site plan.

2 An exact total foot print (floor area) declaration endorsed by an architect for the pharmacy premises. The premises plan and floor area declaration should cover all premises of the pharmacy including all areas used as clinics and any storage space connected with the pharmacy premises and thus covered by the proposed pharmacy licence.

3 Declaration from architect stating the exact distance measured as the shortest walking from nearest other pharmacies in the same locality and neighbouring localities.

4 Comprehensive description of the layout and operation of premises available for the storage and dispensing of medicinal products.

In case of change to managing pharmacist:

1 Curriculum vitae of proposed managing pharmacist.

2 DDA stock take signed by present and proposed managing pharmacists.

3 Annex B.

Please note that a Malta Environment and Planning Authority permit must be supplied by applicant before pharmacy licence is issued in case of sections 3 and 4 of this form.

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ANNEX B- MANGING PHARMACIST DECLARATION FORM

I,

Pharmacy council registration number:

declare that I will be the managing pharmacist for:

Proposed pharmacy name:

Site Address of pharmacy:

Street:

Locality:

Postcode:

I undertake to inform the Medicines Authority in writing of any replacement and/or locum pharmacists that may substitute me as the need arises. A signed declaration shall also be submitted when my duties at the above mentioned pharmacy are terminated.

Signature:

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

Date:

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