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: The product(s) will not be marketed in any presentation since the Marketing
Authorisation(s) has/have been granted [a] Three years will elapse from the date of cessation of the product on the market [b] 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) Page 1 of 2

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) Page 2 of 2