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.
Application Requirements
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
[{"Id":"9389225a-cea4-e911-80d5-005056860673","StageName":"Submission of Application","StageNumber":1,"AddressName":"Medicines Authority","AddressLine1":"Medical Device Unit","AddressLine2":"Sir Temi Zammit Buildings","AddressLine3":"Malta Life Sciences Park","AddressCity":"San Gwann","AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"
[email protected]","Duration":null},{"Id":"c3c93950-cea4-e911-80d5-005056860673","StageName":"Delivery of Service","StageNumber":2,"AddressName":"Medicines Authority","AddressLine1":"Medical Device Unit","AddressLine2":"Sir Temi Zammit Buildings","AddressLine3":"Malta Life Sciences Park","AddressCity":"San Gwann","AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"
[email protected]","Duration":"6 months"}]
apply
