Décision d'autorisation d'importation, de distribution, d'achat, de délivrance et d'administration du médicament BAT [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G) - (Equine)] pour le traitement du botulisme ou d'un empoisonnement avec les toxines de la bactérie Clostridium botulinum, de 2 juin 2022
Article 1er. Le Service public fédéral Santé publique, Sécurité de la Chaîne alimentaire et Environnement (ci-après dénommé " SPF SPSCAE ") est autorisé à procéder à l'achat et à la distribution du médicament susmentionné. Le médicament est intégré dans le stock stratégique géré par le SPF SPSCAE.
Le SPF SPSCAE peut externaliser la gestion du stock stratégique au titulaire d'une autorisation de distribution en gros visée à l'article 12ter, § 1er, alinéa 1er, de la loi du 25 mars 1964 sur les médicaments. Dans ce cas, la distribution et les livraisons visées à l'article 2 sont effectuées conformément aux instructions du SPF SPSCAE.
Art. 2. Le SPF SPSCAE ou le sous-traitant visé à l'article 1er, alinéa 2, fournit le médicament à une officine ouverte au public ou à une officine hospitalière, sur commande et à condition que l'officine pharmaceutique ou officine hospitalière précise que le médicament est prescrit pour un patient spécifique.
Art. 3. Cette décision ne porte pas atteinte à la législation applicable en ce qui concerne la délivrance et l'administration du médicament.
Art. 4. Si une autorisation de mise sur le marché a été accordée pour le médicament en question, les conditionnements du médicament non autorisé qui étaient encore disponibles dans le stock stratégique de l'Etat belge au moment de l'octroi de ladite autorisation, sont distribués et utilisés conformément aux termes de la présente décision.
Art. 5. Cette décision est valable jusqu'au 31 décembre 2027.
Signatures
Bruxelles, le 2 juin 2022.
F. VANDENBROUCKE
Préambule
Le Ministre de la Santé publique,
Vu la loi du 25 mars 1964 sur les médicaments, l'article 6quater, § 1er, alinéa 1er, 5° ) ;
Vu l'arrêté royal du 14 décembre 2006 relatif aux médicaments à...
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