Décision soumettant l'exportation du médicament Actosolv destiné au marché belge à une autorisation préalable, de 6 décembre 2023
Article M. DECIDE de soumettre l'exportation dus médicament Actosolv 100000 IU sol. inj./perf. (pdr) i.v./i.artér.et Actosolv 600000 IU sol. inj./perf. (pdr) i.v./i.artér destinés au marché belge à une autorisation préalable jusqu'au 31 août 2024 inclus.
Cette décision entre en vigueur le jour de sa publication dans le Moniteur belge.
Signatures
Bruxelles, le 6 décembre 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 19 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 ;
Vu la communication à la Commission européenne, le 30 novembre 2023, en application des articles 5, paragraphe 1er, et 6, paragraphe 7, de la directive 2015/1535/UE du Parlement européen et du Conseil du 9 septembre 2015 prévoyant une procédure d'information dans le domaine des réglementations techniques et des règles relatives aux services de la société de l'information;
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, du médicament Actosolv a été communiquée à l'AFMPS ;
Considérant que l'indisponibilité du médicament Actosolv se poursuivrait jusqu'au 31 août 2024 ;
Considérant que le médicament Actosolv est utilisé pour le traitement d'une embolie pulmonaire étendue et aiguë accompagnée d'un état cardio-vasculaire...
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