Overview
Tingħata l-possibilità lill-applikant li jikseb Marketing Authorisation Number< għal prodotti awtorizzati skont il-proċess magħruf bħala Decentralised Procedure jew Mutual Recognition Procedure fl-aħħar fażi tal-proċedura.
What You'll Get
Ċertifikat tal-approvazzjoni kemm-il darba l-applikazzjoni jkollha valutazzjoni pożittiva.
Eligibility
Marketing Authorisation Holders (MAH).
Application Requirements
Imla l-formola onlajn u ibgħatha.
Dokumenti meħtieġa:
i) Prova tal-ħlas
ii) Curriculum Vitae tal-Pesuna Kwalifikata (Qualified Person)
iii) Kopja riċenti tal-Karatteristiċi tal-Prodott fil-Qosor (Summary of Products Characteristics), u fuljett tal-prodott (Package Leaflet)
iv) Rappreżentazzjoni viżwali (mock-ups) tal-pakkett ta' barra u ta' ġewwa. In-numru tal-awtorizzazzjoni tal-kummerċjalizzazzjoni ta’ Malta għandu jkun jidher b’mod ċar fuq il-pakkett ta’ barra
v) Ittra t’aċċess minn għand Market Authorisation Holders, jekk applikabbli
Timeline
[{"Id":"a8936c5a-37d7-ec11-80f1-da8f3f5f197c","StageName":"Sottomissjoni ta' Applikazzjoni","StageNumber":1,"AddressName":"Agriculture and Rural Payments Agency","AddressLine1":"Ghammieri Government Farm","AddressLine2":"Triq l-Ingiered","AddressLine3":null,"AddressCity":"Marsa","AddressPostalCode":"MRS 3303","AddressCountry":"Malta","AddressTelephone":"22926148","AddressEmail":"arpa.msdec@gov.mt","Duration":null},{"Id":"bb936c5a-37d7-ec11-80f1-da8f3f5f197c","StageName":"Iċċekkjar u Approvazzjoni ta' Applikazzjoni","StageNumber":2,"AddressName":"Agriculture and Rural Payments Agency","AddressLine1":"Ghammieri Government Farm","AddressLine2":"Triq l-Ingiered","AddressLine3":null,"AddressCity":"Marsa","AddressPostalCode":"MRS 3303","AddressCountry":"Malta","AddressTelephone":"22926148","AddressEmail":"arpa.msdec@gov.mt","Duration":"15 - il jum"},{"Id":"ce936c5a-37d7-ec11-80f1-da8f3f5f197c","StageName":"Provvista tas-Servizz","StageNumber":3,"AddressName":"Agriculture and Rural Payments Agency","AddressLine1":"Ghammieri Government Farm","AddressLine2":"Triq l-Ingiered","AddressLine3":null,"AddressCity":"Marsa","AddressPostalCode":"MRS 3303","AddressCountry":"Malta","AddressTelephone":"22926148","AddressEmail":"arpa.msdec@gov.mt","Duration":"15 - il jum"}]
applika