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.

Justification for the request for exemption(s)

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

LI013-03 (Appendix 1 Version 1)

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The applicant is requested to inform the Malta Medicines Authority on miau.medicinesauthority@gov.mt and licensing.medicinesauthority@gov.mt when the product is marketed.

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

Name, email, address and position within the company

Name:

Address:

Position within the company:

Email address:

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

Date:

Signature:

The completed form should be sent by email to licensing.medicinesauthority@gov.mt or through CESP

LI013-03 (Appendix 1 Version 1)

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