Klassifikazzjoni ta' Prodott Borderline

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Ħarsa ġenerali

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.

X’se tingħata

Il-prodott jingħatalu l-borderline classification, qabel jitpoġġa fuq is-suq.

Eliġibbiltà

Importaturi u detenituri tal-liċenzji prospetti ta’ prodotti bi klassifikazzjoni mux ċara.

Kif tapplika

Imla l-formola onlajn.

Il-formola għandha tintbagħat lill-Awtorità tal-Mediċini permezz tal-Portal Komuni tal-Preżentazzjoni tal-UE https://cespportal.hma.eu.

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