Décision soumettant l'exportation de médicaments contenant du budésonide en suspension nébulisée destinés au marché belge à une autorisation préalable, de 20 février 2023
Article M.
DECIDE de soumettre l'exportation de médicaments contenant du budésonide en suspension nébulisée destinés au marché belge à une autorisation jusqu'au 15 juillet 2023.Les médicaments visés sont les suivants :1° Budesonide EG 0,25 mg/ml (20 x 2 ml et 60 x 2 ml) et Budesonide EG 0,5 mg/ml (20 x 2 ml et 60 x2 ml) ;2° Budesonide Sandoz 0,25 mg/ml (20 x 2 ml et 60 x2 ml) et Budesonide Sandoz 0,5 mg/ml (20 x 2 ml et 60 x 2 ml) ;3° Budesonide Teva 0,25 mg/ml (20 x 2 ml et 60 x 2 ml) et Budesonide Teva 0,5 mg/ml (20 x 2 ml et 60 x2 ml) ;4° Pulmicort 0,25 mg/ml 20 x 2 ml et Pulmicort 0,5 mg/ml 20 x 2 ml ;5° Pulmicort (PI-pharma) 0,25 mg/ml 20 x 2 ml et Pulmicort (PI-pharma) 0,5 mg/ml 20 x 2 ml ;Cette décision entre en vigueur le jour de sa publication dans le Moniteur belge.
Signatures
Bruxelles, le 16 février 2023.
F. VANDENBROUCKE
Préambule
Le Ministre de la Santé publique,
Vu la loi du 25 mars 1964 sur les médicaments à usage humain, l'article 12septies, alinéa 2 ;
Vu l'arrêté royal du 18 janvier 2023 portant exécution de l'article 12septies, alinéa 2, de la loi du 25 mars 1964 sur les médicaments, l'article 4, § 1er, § 2, alinéa 1er et § 3, alinéa 1er ;
Considérant que l'indisponibilité, au sens de l'article 2, 29), de l'arrêté royal du 14 décembre 2006 relatif aux médicaments à usage humain et vétérinaire, des médicaments contenant la suspension nébulisée de budésonide a été notifiée à l'AFMPS ;
Considérant que pour certains conditionnements de médicaments contenant du budésonide en suspension nébulisée, l'indisponibilité se poursuivrait jusqu'au 15 juillet 2023 et qu'il n'y a aucune certitude d'un approvisionnement suffisant sur le marché belge jusque-là ;
Considérant que le budésonide en suspension nébulisée est utilisé pour le...
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