Transfer of a Marketing Authorisation Holder for an Authorised Product

Overview

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 after the marketing authorisation is already issued.

What you'll get

The transfer of an MA for a product after its issuance.

Eligibility

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 after the Marketing Authorisation is already issued.

How to apply

Fill in the online form.

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