2 JUNI 2022. - Beslissing houdende de toestemming voor de invoer, de verdeling, het aanschaffen, de aflevering en de toediening van het geneesmiddel BAT [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G) - (Equine)] voor de behandeling van botulisme of een vergiftiging met de gifstoffen van de bacterie Clostridium botulinum
De Minister van Volksgezondheid,
Gelet op de wet van 25 maart 1964 op de geneesmiddelen, artikel 6quater, § 1, eerste lid, 5° );
Gelet op het koninklijk besluit van 14 december 2006 betreffende geneesmiddelen voor menselijk en diergeneeskundig gebruik, artikel 110, derde lid;
Gelet op het advies van de Inspecteur van Financiën, gegeven op 18 mei 2022;
Overwegende dat het heptavalente antitoxine tegen botulisme niet vergund is;
Dat botulisme een neurotoxische toxine die een spierverlamming veroorzaakt, die zeer ernstige gevolgen kan hebben, en er derhalve nood is om een voorraad van een dergelijk geneesmiddel beschikbaar te hebben;
Dat dit antitoxine evenwel het enige middel is dat kan worden ingezet, in geval van vergiftiging;
Dat dit antitoxine evenwel snel moet worden verdeeld en toegediend, na de vergiftiging, zodat een ad hoc import van het onvergunde geneesmiddel door een apotheker, op grond van een artsenverklaring, niet haalbaar is;
Dat derhalve toepassing gemaakt kan worden van artikel 6quater, § 1, eerste lid, 5° ), van de wet van 25 maart 1964 op de geneesmiddelen;
BESLUIT de invoer, de verdeling, het aanschaffen, de aflevering en de toediening van BAT [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G) - (Equine)] toe te laten voor de behandeling van botulisme of een vergiftiging met de gifstoffen van de bacterie Clostridium botulinum,
ONDER DE VOLGENDE VOORWAARDEN :
Artikel 1. De Federale Overheidsdienst Volksgezondheid, Veiligheid van de Voedselketen en Leefmilieu (verder "FOD VVVL") wordt gemachtigd om over te gaan tot de aanschaf en de distributie van het hogervermelde geneesmiddel. Het geneesmiddel wordt opgenomen in de door de FOD VVVL beheerde strategische stock.
De FOD VVVL kan het beheer van de...
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