Application for a Variation to a Parallel Import Licence

e-form Application for a Variation to a Parallel Import Licence

1 DETAILS OF THE PROPOSED PARALLEL IMPORT LICENCE HOLDER (PARALLEL IMPORTER)¹ Name: Address: Country: Telephone: Fax: E-Mail: 2 PRODUCT DETAILS Name of the product: Pharmaceutical form: Strength: Parallel import licence number: LI001/07 Appendix 8 Version 1 page 1 of 3

3 NATURE OF THE CHANGE The change affects: SmPC (provide electronic copy of SmPC amended with track changes
and a clean electronic version of the new proposed SmPC). Labels (provide electronic copy of mock ups amended with track
changes and a clean electronic version of the new proposed mock ups). Leaflet (provide electronic copy of package leaflet amended with track
change and a clean electronic version of the new proposed package leaflet). Marketing Authorisation number of Maltese-Market product. Parallel import licence holder's name and/or address. Manufacturer(s) responsible for repackaging/ relabelling. Marketing authorisation number of the product in the source Country. Other. Please specify: Background (Please give brief background information for the proposed change to the parallel import licence): LI001/07 Appendix 8 Version 1 page 2 of 3

4 I hereby apply to vary the Parallel Import Licence. I confirm that no changes have been made to the medicinal product particulars other than those notified to the Medicines Authority. I declare that all changes have been identified and that there are no other changes in the amended documentation. Signature of applicant: 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. Name in Block Letters: Capacity in which signed: Telephone number: Fax number: Date: MEDICINES AUTHORITY USE ONLY: Variation is approved. Rejected. 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. Signature of reviewer: Date: LI001/07 Appendix 8 Version 1 page 3 of 3