Overview

Following the issue of the 126a authorisation, the Authorisation holder must notify the Medicines Authority of any changes to the authorised product, which have been approved in the Member State (EU/EEA country of source) that will affect the details on the authorisation document and/or the product information.

What you'll get

Update of informtion on the Malta Medicines Authority website.

Eligibility

Companies wishing to place a medicinal product on the Maltese market which is already authorised in another EU/EEA Member State.

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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