Overview
Notifika ta’ varjazzjoni għandha tintbagħat lill-Awtorità kompetenti f’każ ta’ tibdil li jaffetwa l-ippakjar jew kontenut (SmPC) tal-prodotti mediċinali importati mill-proċess tal-parallel importation.
What You'll Get
L-Awtorità tiġi infurmata bid-tibdil pjanat.
Eligibility
Detenturi ta' liċenzji għal importazzjoni parallela.
Application Requirements
Imla l-formola onlajn.
Il-formola għandha tintbagħat lill-Awtorità tal-Mediċini permezz tal-Portal Komuni tal-Preżentazzjoni tal-UE
https://cespportal.hma.eu.
Timeline
[{"Id":"3bbe3950-cea4-e911-80d5-005056860673","StageName":"Approvazzjoni ta’ Applikazzjoni","StageNumber":3,"AddressName":"Malta 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":"mdforms.medicinesauthority@gov.mt","Duration":"20 jum"},{"Id":"dfd83950-cea4-e911-80d5-005056860673","StageName":"Provvista tas-Servizz","StageNumber":4,"AddressName":"Malta 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":"mdforms.medicinesauthority@gov.mt","Duration":"5 ijiem"},{"Id":"c181225a-cea4-e911-80d5-005056860673","StageName":"Sottomissjoni ta’ Applikazzjoni","StageNumber":1,"AddressName":"Malta 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":"mdforms.medicinesauthority@gov.mt","Duration":null},{"Id":"8d83841e-1cf7-e911-80dd-b74b77dde526","StageName":"Iċċekkjar ta’ Applikazzjoni","StageNumber":2,"AddressName":"Malta 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":"mdforms.medicinesauthority@gov.mt","Duration":"5 ijiem"}]
applika
