5 NOVEMBRE 2012. - Arrêté royal modifiant l'arrêté royal du 14 novembre 2001 relatif aux dispositifs médicaux de diagnostic in vitro
ALBERT II, Roi des Belges,
A tous, présents et à venir, Salut.
Vu la loi du 25 mars 1964 sur les médicaments, l'article 1erbis, § 1er, 3°, inséré par la loi du 21 juin 1983, § 3, inséré par la loi du 21 juin 1983 et modifié par la loi du 20 octobre 1998, 6, § 1er, alinéas 3 et 4;
Vu l'arrêté royal du 14 novembre 2001 relatif aux dispositifs médicaux de diagnostic in vitro;
Vu l'avis n° 8884 du Conseil supérieur de la Santé, donné le 5 septembre 2012;
Vu l'avis de l'Inspection des Finances, donné le 21 août 2012;
Vu l'urgence, motivée comme suit :
Considérant que le présent arrêté vise à transposer en droit belge la Directive 2011/100/UE de la Commission du 20 décembre 2011 modifiant la Directive 98/79/CE du Parlement européen et du Conseil relative aux dispositifs médicaux de diagnostic in vitro; que le délai pour la transposition a expiré le 30 juin 2012;
Considérant que l'urgence découle spécialement de la mise en demeure du 17 juillet 2012 de la Commission européenne pour défaut de transposition de la directive précitée et et vu que la Commission européenne doit être informée sans delai des mesures prises pour respecter la transposition;
Vu l'examen préalable quant à la nécessité de réaliser une évaluation d'incidence, dont il ressort qu'une évaluation d'incidence n'est pas requise;
Vu l'avis 52.095/3 du Conseil d'Etat, donné le 2 octobre 2012 en application de l'article 84, § 1er, alinéa 1er, 2°, des lois sur le Conseil d'Etat coordonnées le 12 janvier 1973;
Sur la proposition de la Ministre de la Santé publique,
Nous avons arrêté et arrêtons :
Article 1er. Dans le chapitre Ier de l'arrêté royal du 14 novembre 2001 relatif aux dispositifs médicaux de diagnostic in vitro, il est inséré un article 2/1 rédigé comme suit :
Art. 2/1. Les articles 6, § 1er, alinéas 1er, 3, 4, 12, 13 et 14, § 1quinquies, alinéas 1er, 5, 6 et 7, 6septies, alinéas 1er, 4 et 7, 7, § 1er, 8, 8bis, 9, § 1er, alinéas 1er, 5 et 6, et § 2, alinéas 1er, 11, 12bis, § 1er, alinéas 1er, 2, 3, 6, 9, 10...
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