Décret n° 2011-655 du 10 juin 2011 relatif aux modalités de signalement par les patients ou les associations agréées de patients d'effets indésirables susceptibles d'être liés aux médicaments et produits mentionnés à l'article L. 5121-1 du code de la santé publique
Jurisdiction | France |
Date de publication | 12 juin 2011 |
ELI | https://www.legifrance.gouv.fr/eli/decret/2011/6/10/2011-655/jo/texte,https://www.legifrance.gouv.fr/eli/decret/2011/6/10/ETSP1024824D/jo/texte |
Record Number | JORFTEXT000024153599 |
Publication au Gazette officiel | JORF n°0136 du 12 juin 2011 |
Court | Ministère du travail, de l'emploi et de la santé |
Enactment Date | 10 juin 2011 |
Publics concernés : patients, associations de patients agréées et centres régionaux de pharmacovigilance.
Objet : signalement par les patients ou associations de patients des effets indésirables de certains médicaments et produits.
Entrée en vigueur : le lendemain de la publication.
Notice : le présent décret tire les conséquences au niveau réglementaire de l'extension par le législateur du dispositif de pharmacovigilance aux patients et associations de patients agréées en leur permettant de signaler directement les effets indésirables des médicaments et produits mentionnés à l'article L. 5121-1 du code de la santé publique.
Les modalités de recueil, de vérification et d'évaluation de ces signalements sont quant à elles précisées par arrêté du ministre chargé de la santé sur proposition du directeur de l'Agence française de sécurité sanitaire des produits de santé (AFSSAPS) conformément à l'article R. 5121-179 du code de la santé publique.
Références : les textes visés par ce décret peuvent être consultés sur le site Légifrance (http://www.legifrance.gouv.fr).
Le Premier ministre,
Sur le rapport du ministre du travail, de l'emploi et de la santé,
Vu le code de la santé publique, notamment l'article L. 5121-20 ;
Le Conseil d'Etat (section sociale) entendu,
Décrète :
Il est ajouté à la fin de l'article R. 5121-154 du code de la santé...
Pour continuer la lecture
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