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:

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:

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