Transfer of a Marketing Authorisation Holder During the Authorisation Procedure

Overview

The transfer procedure must be used where the legal entity of an authorisation/registration holder is changed and the product is transferred to a new company during the authorisation procedure stage. When an authorisation is transferred during the national phase but before the granting of the marketing authorisation, the new holder must notify the Medicines Authority using Transfer Form B. Once the application is considered valid, the transfer will be processed within approximately 60 days.

What you'll get

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.

Eligibility

Marketing Authorisation Holders in line with the necessary requirements.

How to apply

Fill in the online form.

 

Applications must be sent to the Malta Medicines Authority through the Common EU Submission Portalhttps://cespportal.hma.eu.

 

Documents required

Please refer to application form

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