e-form

Application for the Transfer of a Marketing Authorisation Holder during the Authorisation Procedure – (National Phase)

Please note that submission must be sent electronically through the Common European Submission Portal – CESP).

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.





Details of documents to be submitted : (Kindly indicate if submitted)











• Marketing Authorisation Holder Name

• Address



• Marketing Authorisation Number for Malta





6. Pharmacovigilance system master file (PSMF) : (Kindly indicate if submitted )





* 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 2 Version 01

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