Koninklijk besluit houdende vaststelling van de voorwaarden voor het voorschrijven en de aflevering van fenfluramine, de 6 novembre 2023
Artikel 1. De aflevering van geneesmiddelen die fenfluramine of dexfenfluramine bevatten is slechts toegestaan indien zij werden voorgeschreven door een arts-specialist in de neurologie.
Art. 2. Het voorschrijven van geneesmiddelen die fenfluramine en/of dexfenfluramine bevatten is voorbehouden aan de arts-specialist in de neurologie, en beperkt tot de volgende gevallen:
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vergunde geneesmiddelen, uitsluitend voor de indicaties waarvoor zij vergund zijn;
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geneesmiddelen die zijn bestemd voor het gebruik in een klinische proef, uitgevoerd in overeenstemming met de Verordening (EU) nr. 536/2014 van het Europees Parlement en de Raad van 16 april 2014 betreffende klinische proeven met geneesmiddelen voor menselijk gebruik en tot intrekking van Richtlijn 2001/20/EG;
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geneesmiddelen onder de vorm van een magistrale bereiding, met dezelfde samenstelling van werkzame stoffen als een vergund geneesmiddel, indien er een onbeschikbaarheid is van dat geneesmiddel in de zin van artikel 2, 29), van het koninklijk besluit van 14 december 2006 betreffende geneesmiddelen voor menselijk en diergeneeskundig gebruik of de onderbreking van het in de handel brengen in de zin van artikel 2, 30), van hetzelfde koninklijk besluit, genotificeerd aan het Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten en gepubliceerd op haar website, en uitsluitend voor de indicaties waarvoor het geneesmiddel vergund is.
Art. 3. Het koninklijk besluit van 11 juli 2001 houdende verbod van de aflevering van geneesmiddelen die fenfluramine en/of dexfenfluramine bevatten wordt opgeheven.
Art. 4. De minister bevoegd voor de Volksgezondheid is belast met de uitvoering van dit besluit.
Handtekening
Gegeven te Brussel, 6 november 2023.
FILIP
Van Koningswege :
De Minister van Volksgezondheid,
F. VANDENBROUCKE
Aanhef
FILIP...
Pour continuer la lecture
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