Application Form for the Transfer of a Marketing Authorisation Holder for an Authorised* Product
Please note that submission must be sent electronically (through the Common European Submission Portal – CESP).
* When a Marketing Authorisation has already been issued by the Malta Medicines Authority
This application enables a company to take over responsibility from another company (different legal entity) where the application is in identical terms to the existing marketing authorisation.
DOCUMENTS WHICH HAVE TO BE SUBMITTED WITH THE APPLICATION FORM FOR A MARKETING AUTHORISATION TRANSFER FOR AN AUTHORISED PRODUCT:
Marketing Authorisation Number of Malta:
*If the proposed MAH and the previous MAH belong to the same group of companies and the PSMF is going to be shared, a variation to the PSMF may not be required.
LI017/05 Appendix 1 Version 02