e-form

''Sunset Clause'' -
Request for an Exemption from the invalidation of a Marketing Authorisation

The Marketing Authorisation(s) for the below-mentioned product(s) will become invalid in Malta in accordance with Articles 24(4) and 24(5) of Directive 2001/83 as amended. The product(s) has/have not been marketed in any presentation since the Marketing Authorisation(s) was/were granted.

Name of medicinal product(s):

Marketing Authorisation number(s):

Marketing Authorisation Holder name and address:

Date of issue of the Marketing Authorisation(s):

Please consider allowing the Marketing Authorisation(s) to remain valid for an additional

years.

An exemption may be requested for a minimum of one and a maximum of three years.

Justification for the request for exemption(s):

Further documentation may be attached to this form in support of the request.

I declare that the above information is correct and that any changes will be communicated to the Medicines Authority with immediate effect.

F-LI02-01 (October 2015)

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Name:

Address:

Position within the company:

If the signatory is not the Marketing Authorisation Holder, please attach a letter of authorisation on his behalf

Date:

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.

F-LI02-01 (October 2015)

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