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.
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":"9189225a-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":"c1c93950-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":"4 months"}]
apply
