Overview
L-applikant jista' jikseb valutazzjoni pożittiva għal prodotti mediċinali veterinarji skont ir-regolament 4(2) tal-Liġi Sussidjarja 437.47.
What You'll Get
Ċertifikat tal-approvazzjoni jingħataw kemm-il darba l-applikazzjoni jkollha valutazzjoni pożittiva.
Eligibility
Authorisation Holders intenzjonati u bejjiegħa bl-ingrossa (Wholesale Dealers).
Application Requirements
Imla l-formola onlajn u ibgħatha.
Dokumenti meħtieġa:
i) Prova tal-ħlas
ii) Curriculum Vitae tal-Persuna Kwalifikata (Qualified Person)
iii) Summarju tal-Karatteristiċi tal-Prodott fil-Qosor (Summary of Products Characteristics), fuljett tal-prodott (Package Leaflet), u rappreżentazzjoni viżwali (mock-ups) tal-pakkett ta' barra u ta' ġewwa
iv) Prova tal-istabbilizazzjoni ta’ min hu propost li jkollu l-AwtorizazzjonI f’pajjiż tal-UE/EEA
v) Kopja tal-liċenzja tal-GMP (jekk applikabli)
vi) Tikketta fuq barra li turi prodott jista’ jiġi amministrat biss lil annimali żgħar u mhux tal-ikel kif ipprovdut mir-Regolament 4(2) tal-Leġislazzjoni Sussidjarja 437.47
vii) Kopja ta’ Prattika Tajba ta’ Manifattura (Good Manufacturing Practice) mogħtija lill-manifattur tal-prodott (jekk disponibbli)
Timeline
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applika