Arrêté royal fixant les conditions de prescription et de délivrance de la fenfluramine, de 6 novembre 2023
Article 1er. La délivrance de médicaments contenant de la fenfluramine ou de la dexfenfluramine n'est autorisée que sur prescription d'un médecin spécialiste en neurologie.
Art. 2. La prescription de médicaments contenant de la fenfluramine et/ou de la dexfenfluramine est réservée au médecin spécialiste en neurologie, et limitée aux cas suivants :
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les médicaments autorisés, exclusivement pour les indications pour lesquelles ils sont autorisés ;
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les médicaments destinés à être utilisés dans le cadre d'un essai clinique, conduit conformément au règlement (UE) n° 536/2014 du Parlement européen et du Conseil du 16 avril 2014 relatif aux essais cliniques de médicaments à usage humain et abrogeant la directive 2001/20/CE ;
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les médicaments sous forme de préparation magistrale, ayant la même composition en substances actives qu'un médicament autorisé, en cas d'indisponibilité de ce médicament au sens de l'article 2, 29), de l'arrêté royal du 14 décembre 2006 relatif aux médicaments à usage humain et vétérinaire ou d'interruption de la mise sur le marché au sens de l'article 2, 30), du même arrêté, notifiée à l'Agence fédérale des médicaments et des produits de santé et publié sur son site internet, et exclusivement pour les indications pour lesquelles le médicament est autorisé.
Art. 3. L'arrêté royal du 11 juillet 2001 portant interdiction de la délivrance des médicaments contenant de la fenfluramine et/ou de la dexfenfluramine est abrogé.
Art. 4. Le ministre qui a la Santé publique dans ses attributions est chargé de l'exécution du présent arrêté.
Signatures
Donné à Bruxelles, le 6 novembre 2023.
PHILIPPE
Par le Roi :
Le Ministre de la Santé publique,
F. VANDENBROUCKE
Préambule
PHILIPPE, Roi...
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