Loi modifiant la loi du 25 mars 1964 sur les médicaments en ce qui concerne les programmes d'usage compassionnel et les programmes médicaux d'urgence, de 22 novembre 2020
Article 1er. La présente loi règle une matière visée à l'article 74 de la Constitution
Art. 2. Dans l'article 6quater, § 1er, alinéa 1er, de la loi du 25 mars 1964 sur les médicaments, rétabli par la loi du 1er mai 2006 et modifié, en dernier lieu, par la loi du 17 juillet 2015, les modifications suivantes sont apportées:
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le 2° est remplacé par ce qui suit:
"Le Roi peut également fixer des règles concernant la mise à disposition de médicaments à usage humain en vue d'un usage compassionnel.
Par "usage compassionnel", on entend la mise à disposition, pour des raisons compassionnelles, d'un médicament, relevant d'une catégorie visée à l'article 3, paragraphes 1 et 2, du Règlement (CE) N° 726/2004, à un groupe de patients souffrant d'une maladie chronique, d'une maladie qui affaiblit gravement la santé ou d'une maladie constituant une menace pour la vie, et qui ne peut être traitée de manière satisfaisante au moyen d'un médicament autorisé, commercialisé et remboursé.
Conformément à l'article 6 du même Règlement, le médicament concerné doit soit avoir fait l'objet d'une demande d'autorisation de mise sur le marché, ou être en cours d'essais cliniques.";
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le 3°, alinéa 2, première phrase, est complété par les mots "et remboursé".
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