Request for Sunset Clause Exemption

Last Updated: Tuesday 16 June 2026

Overview

Request for an exemption from the invalidation of a Marketing Authorisation.

What you'll get

Sunset clause exemption (if applicable).

Eligibility

Companies placing medicinal products on the market.

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).

Timeline

Submission of Application

Delivery of Service

1 month

Submit your application

Apply