Overview
Notification of changes to labelling and package leaflets.
What you'll get
The form is used to inform the Medicines Authority of more than 1 change relating to a product. One form per product must be filled in.
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).
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
4 months
