Overview
Il-formola ta’ Klassifikazzjoni ta' Prodott Borderline għandha timtela għall-awtorizzar ta’ prodotti li ma jaqgħux b’mod ċar taħt id-definizzjoni ta’ prodott mediċinali hekk kif stipulat fl-Att dwar il-Mediċini, Att III ta’ 2003.
What You'll Get
Il-prodott jingħatalu l-borderline classification, qabel jitpoġġa fuq is-suq.
Eligibility
Importaturi u detenituri tal-liċenzji prospetti ta’ prodotti bi klassifikazzjoni mux ċara.
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":"8581225a-cea4-e911-80d5-005056860673","StageName":"Sottomissjoni ta’ Applikazzjoni","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":"c3cf3950-cea4-e911-80d5-005056860673","StageName":"Iċċekkjar ta’ Applikazzjoni","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":"12 - il jum"},{"Id":"798f225a-cea4-e911-80d5-005056860673","StageName":"Valutazzjoni ta’ Applikazzjoni","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":"Ġurnata"},{"Id":"0bbe3950-cea4-e911-80d5-005056860673","StageName":"Approvazzjoni ta’ Applikazzjoni","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":"Xahar"},{"Id":"a3d83950-cea4-e911-80d5-005056860673","StageName":"Provvista tas-Servizz","StageNumber":5,"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 ijiem"}]
applika
