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) will not be marketed in any presentation since the Marketing Authorisation(s) has/have been granted or when 3 years will elapse from the date of cessation of the product on the market.

1. Name of medicinal product(s):

2. Marketing Authorisation number(s):

3. Marketing Authorisation Holder name and address:

4. Choose as applicable:

If [b] is chosen, provide documentation/evidence regarding the last
marketing status of the product.

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.

LI013-01 (Appendix 1 Version 1)

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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.

Name:

Address:

Position within the company:

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

Signature:

Date:

LI013-01 (Appendix 1 Version 1)

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