Overview

Application of authorisation/renewal in line with regulation 4(2) of the Medicines (Marketing Authorisation) Regulations, in accordance with article 126(a) of Directive 2001/83/EC.

What you'll get

Authorisation/Renewal in line with regulation 4(2) of the Medicines (Marketing Authorisation) Regulations, in accordance with article 126(a) of Directive 2001/83/EC.

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).
apply