Overview
A notification of variation should be provided to the competent agency in case of changes affecting labelling, packaging or SmPC of medicinal products imported through the parallel import process.
What You'll Get
The changes will be notified to the competent authority.
Eligibility
Parallel import licence holders.
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":"8588225a-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":null,"AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"mdforms.medicinesauthority@gov.mt","Duration":null},{"Id":"7083841e-1cf7-e911-80dd-b74b77dde526","StageName":"Vetting of Application","StageNumber":2,"AddressName":"Medicines Authority","AddressLine1":"Medical Device Unit","AddressLine2":"Sir Temi Zammit Buildings","AddressLine3":"Malta Life Sciences Park","AddressCity":null,"AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"mdforms.medicinesauthority@gov.mt","Duration":"5 days"},{"Id":"4fba3950-cea4-e911-80d5-005056860673","StageName":"Approval of Application","StageNumber":3,"AddressName":"Medicines Authority","AddressLine1":"Medical Device Unit","AddressLine2":"Sir Temi Zammit Buildings","AddressLine3":"Malta Life Sciences Park","AddressCity":null,"AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"mdforms.medicinesauthority@gov.mt","Duration":"20 days"},{"Id":"b5c83950-cea4-e911-80d5-005056860673","StageName":"Delivery of Service","StageNumber":4,"AddressName":"Medicines Authority","AddressLine1":"Medical Device Unit","AddressLine2":"Sir Temi Zammit Buildings","AddressLine3":"Malta Life Sciences Park","AddressCity":null,"AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"mdforms.medicinesauthority@gov.mt","Duration":"5 days"}]
apply
