Overview
Il-formola tippermetti lil Registration Holders ta' prodotti awtorizzati skont ir-Regolament 7 tal-Liġi Sussidjarja 437.47, u Authorisation Holders skont ir-Regolament 4(2) tal-Liġi Sussidjarja 437.47, sabiex jinnotifikaw lill-AHWD dwar tibdil fl-informazzjoni tal-prodotti mediċinali veterinarji
What You'll Get
L-applikanti jiġu kkuntatjati jekk ikun hemm bżonn ta' kjarifika.
Eligibility
Il-persuna li fuqha hemm irreġistrat il-mediċina veterinarja (Registration Holders) ta' prodotti awtorizzati skont ir-Regolament 7 tal-LS 437.47.
Application Requirements
Imla l-formola onlajn u ibgħatha.
Dokumenti meħtieġa:
i) Kopji tal-aktar verżjoni riċenti tas-Sommarju tal-Karatteristiċi tal-Prodott (Summary of Products Characteristics) u l-Fuljett Informattiv fil-Pakkett (PIL)
ii) Mock-up tal-ittikkettar ta’ barra tal-prodott li ser jitqiegħed fis-suq Malti
iii) Fil-każ ta’ reġistrazzjoni skont ir-Regolament 7 tal-LS 437.47, ittri ta’ approvazzjoni mill-pajjiż sors maħruga mill-awtorità kompetenti (jekk disponibli).
Timeline
[{"Id":"5dd6a032-2012-ec11-80e8-005056860f48","StageName":"Sottomissjoni ta’ Applikazzjoni","StageNumber":1,"AddressName":"Animal Health and Welfare Department","AddressLine1":"Abattoir Street","AddressLine2":null,"AddressLine3":"Albertown","AddressCity":"Marsa","AddressPostalCode":"MRS1123","AddressCountry":null,"AddressTelephone":"+ 356 2095 3791 / + 356 2095 3804","AddressEmail":"veterinarymedicine@gov.mt","Duration":null},{"Id":"18d7a032-2012-ec11-80e8-005056860f48","StageName":"Iċċekkjar ta’ Applikazzjoni","StageNumber":2,"AddressName":"Animal Health and Welfare Department","AddressLine1":"Abattoir Street","AddressLine2":null,"AddressLine3":"Albertown","AddressCity":"Marsa","AddressPostalCode":"MRS1123","AddressCountry":null,"AddressTelephone":"+ 356 2095 3791 / + 356 2095 3804","AddressEmail":"veterinarymedicine@gov.mt","Duration":"15 - il jum"},{"Id":"2fd7a032-2012-ec11-80e8-005056860f48","StageName":"Valutazzjoni ta’ Applikazzjoni","StageNumber":3,"AddressName":"Animal Health and Welfare Department","AddressLine1":"Abattoir Street","AddressLine2":null,"AddressLine3":"Albertown","AddressCity":"Marsa","AddressPostalCode":"MRS1123","AddressCountry":null,"AddressTelephone":"+ 356 2095 3791 / + 356 2095 3804","AddressEmail":"veterinarymedicine@gov.mt","Duration":"15 - il jum"},{"Id":"45d7a032-2012-ec11-80e8-005056860f48","StageName":"Provvista tas-Servizz","StageNumber":4,"AddressName":"Animal Health and Welfare Department","AddressLine1":"Abattoir Street","AddressLine2":null,"AddressLine3":"Albertown","AddressCity":"Marsa","AddressPostalCode":"MRS1123","AddressCountry":null,"AddressTelephone":"+ 356 2095 3791 / + 356 2095 3804","AddressEmail":"veterinarymedicine@gov.mt","Duration":"14 - il jum"}]
applika
