Overview
The Malta Medicines Authority may consider a batch-specific request application from a Marketing Authorisation Holder (MAH) in order to ensure the continued availability of a medicine on the Maltese market.
What you'll get
Consideration of a batch specific request and approval.
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
6 months
