Overview
Applikazzjoni ta 'awtorizzazzjoni skond ir-regolament 4 (2) tar-Regolamenti dwar Mediċini (Awtorizzazzjoni għat-Tqegħid fis-Suq), skond l-artikolu 126 (a) tad-Direttiva 2001/83 / KE. Din il-bażi legali għandha tintuża biss għal raġunijiet ta 'bżonn ta' saħħa pubblika u għat-tqegħid ta 'prodotti fis-suq f'Malta biss.
What You'll Get
Awtorizzazzjoni skont ir-regolament 4 (2) tar-Regolamenti dwar il-Mediċini (Awtorizzazzjoni għat-Tqegħid fis-Suq), skont l-artikolu 126 (a) tad-Direttiva 2001/83 / EC
Eligibility
Kumpaniji li jixtiequ jqiegħdu prodott mediċinali fis-suq Malti li huwa diġà awtorizzat fi Stat Membru ieħor tal-UE / EEA fuq il-bażi tal-ħtieġa tas-saħħa pubblika determinata mill-Awtorità tal-Mediċini.
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":"09bf3950-cea4-e911-80d5-005056860673","StageName":"Approvazzjoni ta’ Applikazzjoni","StageNumber":3,"AddressName":"Medicines Authority","AddressLine1":"Sir Temi Zammit Buildings","AddressLine2":"Malta Life Sciences Park","AddressLine3":null,"AddressCity":"San Gwann","AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"info.medicinesauthority@gov.mt","Duration":"xahar u nofs"},{"Id":"f3d93950-cea4-e911-80d5-005056860673","StageName":"Provvista tas-Servizz","StageNumber":4,"AddressName":"Medicines Authority","AddressLine1":"Sir Temi Zammit Buildings","AddressLine2":"Malta Life Sciences Park","AddressLine3":null,"AddressCity":"San Gwann","AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"info.medicinesauthority@gov.mt","Duration":"5 ijiem"},{"Id":"d582225a-cea4-e911-80d5-005056860673","StageName":"Sottomissjoni ta’ Applikazzjoni","StageNumber":1,"AddressName":"Medicines Authority","AddressLine1":"Sir Temi Zammit Buildings","AddressLine2":"Malta Life Sciences Park","AddressLine3":null,"AddressCity":"San Gwann","AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"info.medicinesauthority@gov.mt","Duration":null},{"Id":"f193d780-1ef7-e911-80d7-005056860f48","StageName":"Iċċekkjar ta’ Applikazzjoni","StageNumber":2,"AddressName":"Medicines Authority","AddressLine1":"Sir Temi Zammit Buildings","AddressLine2":"Malta Life Sciences Park","AddressLine3":null,"AddressCity":"San Gwann","AddressPostalCode":"SGN 3000","AddressCountry":"Malta","AddressTelephone":"2343 9000","AddressEmail":"info.medicinesauthority@gov.mt","Duration":"5 ijiem"}]
applika
