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Conformiteitsverklaring betreffende bijsluiter voor parallel import dossiers
Ondergetekende (naam verantwoordelijke apotheker , naam firma PI) verklaart dat de bijgevoegde bijsluiters opgesteld in de drie nationale landstalen voor de aanvraag tot vergunning tot parallel import van (benaming geneesmiddel) uit (land van herkomst) identiek zijn aan versie (goedkeuringsdatum bijsluiter referentiegeneesmiddel) van het in Belgi actueel vergunde geneesmiddel : (benaming geneesmiddel + registratienummer).
Hieraan zijn de wettelijke bepalingen, toepasselijk op parallel import van geneesmiddelen toegevoegd, zoals voorzien in de betreffende wetgeving.
(artikel 10 2 van KB 19/04/2001 betreffende parallelinvoer). Ondergetekende draagt hiertoe de verantwoordelijkheid.
Indien uit willekeurige steekproeven vr verlening van de vergunning tot parallelinvoer blijkt dat de ingediende bijsluiters opgesteld in de drie nationale landstalen ,geen getrouwe en correcte weergave zijn van versie (goedkeuringsdatum bijsluiter referentiegeneesmiddel) van het in Belgi actueel vergunde geneesmiddel (benaming geneesmiddel + registratienummer), wordt ondergetekende door het Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) gevraagd zich te verantwoorden en worden de bijsluiters opgesteld in de drie nationale landstalen teruggestuurd voor verbetering.
De ondergetekende draagt de verantwoordelijkheid voor de vertraging die deze verbetering oplevert.
De interpretatie van getrouwe en correcte weergave is steeds te beschouwen in het licht van de bescherming van de volksgezondheid en onderworpen aan het principe van proportionaliteit.
De verantwoordelijke apotheker (naam firma) :
(handtekening , naam en voornaam in blokletters )
Datum :
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