{ "texte_version": { "JORFTEXT000000577884": { "SM": { "CONTENU": "LE MANDAT DES MEMBRES DE LA COMMISSION CONSULTATIVE D'ENREGISTREMENT DES REACTIFS PREVUE A L'ART. 6 DU DECRET 96351 DU 19-04-1996 RELATIF AUX REACTIFS MENTIONNES A L'ART. L761-14-1 DU CODE DE LA SANTE PUBLIQUE,NOMMES PAR L'ARRETE DU 07-08-1996,EST PROLONGE JUSQU'AU 31-01-2000." }, "META": { "META_SPEC": { "META_TEXTE_VERSION": { "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000375877", "#text": "Décret n°96-351 du 19 avril 1996", "@sens": "source", "@cidtexte": "JORFTEXT000000375877", "@nortexte": "TASP9620283D", "@numtexte": "96-351", "@typelien": "APPLICATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-04-19" }, { "@id": "JORFTEXT000000378518", "#text": "Arrêté du 7 août 1996", "@sens": "source", "@cidtexte": "JORFTEXT000000378518", "@nortexte": "TASP9623117A", "@typelien": "MODIFIE", "@naturetexte": "ARRETE", "@datesignatexte": "1996-08-07" } ] }, "TITRE": "Arrêté du 5 août 1999", "MCS_TXT": { "MC": [ "EMPLOI", "SOLIDARITE", "SANG", "PRODUIT SANGUIN", "TRANSFUSION SANGUINE", "GROUPE SANGUIN", "REACTIF", "COMMISSION CONSULTATIVE D'ENREGISTREMENT DES REACTIFS", "ORGANISME CONSULTATIF", "AGENCE DU MEDICAMENT", "EPA", "MEMBRE", "PROROGATION DE MANDAT", "NOMINATION", "MESURE NOMINATIVE" ] }, "MINISTERE": "MINISTERE DE L'EMPLOI ET DE LA SOLIDARITE", "TITREFULL": "Arrêté du 5 août 1999 portant prolongation du mandat des membres de la commission consultative d'enregistrement des réactifs" }, "META_TEXTE_CHRONICLE": { "CID": "JORFTEXT000000577884", "NOR": "MESM9922571A", "DATE_PUBLI": "1999-09-29", "DATE_TEXTE": "1999-08-05", "ORIGINE_PUBLI": "JORF n°226 du 29 septembre 1999", "PAGE_DEB_PUBLI": 14440, "PAGE_FIN_PUBLI": 14440 } }, "META_COMMUN": { "ID": "JORFTEXT000000577884", "URL": "texte/version/JORF/TEXT/00/00/00/57/78/JORFTEXT000000577884.xml", "NATURE": "ARRETE", "ORIGINE": "JORF", "ANCIEN_ID": "1AX9990929P1" } } }, "JORFTEXT000000375877": { "SM": { "CONTENU": "APPLICATION DES ART. 19 DE LA LOI 935 DU 04-014-1993,32 DE LA LOI 9443 DU 18-01-1994.
CONFORMEMENT AUX DISPOSITIONS DE L'ART. L761-14-1 DU CODE DE LA SANTE PUBLIQUE,LES REACTIFS DESTINES AUX LABORATOIRES D'ANALYSES DE BIOLOGIE MEDICALE ET LES REACTIFS MENTIONNES A L'ART. L512 (2EMEMENT) DU CODE SUSMENTIONNE NE PEUVENT ETRE MIS SUR LE MARCHE,A TITRE GRATUIT OU ONEREUX,QUE S'ILS ONT FAIT PREALABLEMENT L'OBJET D'UN ENREGISTREMENT DANS LES CONDITIONS PREVUES PAR LE PRESENT DECRET.
PROCEDURE D'ENREGISTREMENT POUR LES REACTIFS UTILISES DANS LES LABORATOIRES D'ANALYSE DE BIOLOGIE MEDICALE MAIS AUSSI POUR LES REACTIFS DESTINES AU PUBLIC.
CONSTITUTION DU DOSSIER DE DEMANDE D'ENREGISTREMENT:
ELEMENTS DEVANT FITURER DANS LE DOSSIER AINSI QUE CEUX DONNES A L'UTILISATEUR SUR L'EMBALLAGE ET LA NOTICE.
POSSIBILITE DE RETRAIT,PAR LE DIRECTEUR GENERAL DE L'AGENCE DU MEDICAMENT,D'UN REACTIF DU MARCHE SI LES REGLES FIXEES DANS LE DECRET NE SONT PAS RESPECTEES OU EN CAS DE NON-RESPECT DE CERTAINES DISPOSITIONS DU DECRET.
CREATION ET COMPETENCES D'UNE COMMISSION CONSULTATIVE D'ENREGISTREMENT DES REACTIFS (MODE DE NOMINATION DU PRESIDENT ET DES MEMBRES).
INFRACTIONS PENALES.
ABROGATION DU DECRET DU 08-09-1982." }, "ABRO": { "CONTENU": "Texte totalement abrogé" }, "META": { "META_SPEC": { "META_TEXTE_VERSION": { "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000336501", "#text": "Décret du 8 septembre 1982", "@sens": "source", "@cidtexte": "JORFTEXT000000336501", "@typelien": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "1982-09-08" }, { "@id": "JORFTEXT000000178299", "#text": "Loi n°93-5 du 4 janvier 1993", "@sens": "source", "@cidtexte": "JORFTEXT000000178299", "@nortexte": "SPSX9200032L", "@numtexte": "93-5", "@typelien": "APPLICATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-04" }, { "@id": "JORFTEXT000000728979", "#text": "Loi n°94-43 du 18 janvier 1994", "@sens": "source", "@cidtexte": "JORFTEXT000000728979", "@nortexte": "SPSX9300136L", "@numtexte": "94-43", "@typelien": "APPLICATION", "@naturetexte": "LOI", "@datesignatexte": "1994-01-18" }, { "@id": "JORFTEXT000000730207", "#text": "ARRETE", "@sens": "cible", "@cidtexte": "JORFTEXT000000730207", "@nortexte": "TASP9622391A", "@typelien": "APPLICATION", "@naturetexte": "ARRETE", "@datesignatexte": "1996-07-05" }, { "@id": "JORFTEXT000000379964", "#text": "ARRETE", "@sens": "cible", "@cidtexte": "JORFTEXT000000379964", "@nortexte": "TASP9623575A", "@typelien": "APPLICATION", "@naturetexte": "ARRETE", "@datesignatexte": "1996-09-27" }, { "@id": "JORFTEXT000000379962", "#text": "ARRETE", "@sens": "cible", "@cidtexte": "JORFTEXT000000379962", "@nortexte": "TASP9623576A", "@typelien": "APPLICATION", "@naturetexte": "ARRETE", "@datesignatexte": "1996-09-27" }, { "@id": "JORFTEXT000000394392", "#text": "DECRET99-147", "@sens": "cible", "@cidtexte": "JORFTEXT000000394392", "@nortexte": "MESP9824096D", "@numtexte": "99-147", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "1999-03-04" }, { "@id": "JORFTEXT000000577884", "#text": "ARRETE", "@sens": "cible", "@cidtexte": "JORFTEXT000000577884", "@nortexte": "MESM9922571A", "@typelien": "APPLICATION", "@naturetexte": "ARRETE", "@datesignatexte": "1999-08-05" }, { "@id": "JORFTEXT000000384474", "#text": "DECISION", "@sens": "cible", "@cidtexte": "JORFTEXT000000384474", "@nortexte": "MESM9923192S", "@typelien": "APPLICATION", "@naturetexte": "DECISION", "@datesignatexte": "1999-10-08" }, { "@id": "JORFTEXT000000744751", "#text": "DECISION", "@sens": "cible", "@cidtexte": "JORFTEXT000000744751", "@nortexte": "MESM9923193S", "@typelien": "APPLICATION", "@naturetexte": "DECISION", "@datesignatexte": "1999-10-08" }, { "@id": "JORFTEXT000000560797", "#text": "DECISION", "@sens": "cible", "@cidtexte": "JORFTEXT000000560797", "@nortexte": "MESM9923194S", "@typelien": "APPLICATION", "@naturetexte": "DECISION", "@datesignatexte": "1999-10-08" }, { "@id": "JORFTEXT000000744750", "#text": "DECISION", "@sens": "cible", "@cidtexte": "JORFTEXT000000744750", "@nortexte": "MESM9923191S", "@typelien": "APPLICATION", "@naturetexte": "DECISION", "@datesignatexte": "1999-10-08" }, { "@id": "JORFTEXT000000384475", "#text": "DECISION", "@sens": "cible", "@cidtexte": "JORFTEXT000000384475", "@nortexte": "MESM9923195S", "@typelien": "APPLICATION", "@naturetexte": "DECISION", "@datesignatexte": "1999-10-08" }, { "@id": "JORFTEXT000000744749", "#text": "DECISION", "@sens": "cible", "@cidtexte": "JORFTEXT000000744749", "@nortexte": "MESM9923190S", "@typelien": "APPLICATION", "@naturetexte": "DECISION", "@datesignatexte": "1999-10-08" }, { "@id": "JORFTEXT000000214760", "#text": "Décision", "@sens": "cible", "@cidtexte": "JORFTEXT000000214760", "@nortexte": "MESM9923572S", "@typelien": "APPLICATION", "@naturetexte": "DECISION", "@datesignatexte": "1999-11-09" }, { "@id": "LEGIARTI000006228410", "@num": "4", "#text": "Décret n°2004-108 du 4 février 2004 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000416306", "#text": "Décret2004-108", "@sens": "cible", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000421679", "#text": "Décret2004-802", "@sens": "cible", "@cidtexte": "JORFTEXT000000421679", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006915748", "@num": "R5133-1", "#text": "Code de la santé publique - art. R5133-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915749", "@num": "R5133-2", "#text": "Code de la santé publique - art. R5133-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915750", "@num": "R5133-3", "#text": "Code de la santé publique - art. R5133-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916465", "@num": "R5433-1", "#text": "Code de la santé publique - art. R5433-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916466", "@num": "R5433-2", "#text": "Code de la santé publique - art. R5433-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916467", "@num": "R5433-3", "#text": "Code de la santé publique - art. R5433-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916468", "@num": "R5433-4", "#text": "Code de la santé publique - art. R5433-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "TITRE": "Décret n°96-351 du 19 avril 1996", "MCS_TXT": { "MC": [ "TRAVAIL", "AFFAIRES SOCIALES", "SANTE PUBLIQUE", "ANALYSE DE BIOLOGIE MEDICALE", "EXPERTISE TECHNIQUE", "CONTROLE DE QUALITE", "LABORATOIRE D'ANALYSE DE BIOLOGIE MEDICALE", "REACTIF", "IMPORTATION", "MISE SUR LE MARCHE", "COMMERCIALISATION", "UTILISATION", "DOSSIER", "DEMANDE D'ENREGISTREMENT", "EMBALLAGE", "NOTICE", "AGENCE DU MEDICAMENT", "EPA", "DIRECTEUR GENERAL", "COMPETENCE", "RETRAIT", "INFRACTION", "SANCTION PENALE", "CREATION", "COMPOSITION", "COMMISSION" ] }, "MINISTERE": "MINISTERE DU TRAVAIL ET DES AFFAIRES SOCIALES", "TITREFULL": "Décret no 96-351 du 19 avril 1996 relatif aux réactifs mentionnés à l'article L. 761-14-1 du code de la santé publique" }, "META_TEXTE_CHRONICLE": { "CID": "JORFTEXT000000375877", "NOR": "TASP9620283D", "NUM": "96-351", "DATE_PUBLI": "1996-04-26", "DATE_TEXTE": "1996-04-19", "ORIGINE_PUBLI": "JORF n°99 du 26 avril 1996", "PAGE_DEB_PUBLI": 6386, "PAGE_FIN_PUBLI": 19960426 } }, "META_COMMUN": { "ID": "JORFTEXT000000375877", "URL": "texte/version/JORF/TEXT/00/00/00/37/58/JORFTEXT000000375877.xml", "NATURE": "DECRET", "ORIGINE": "JORF", "ANCIEN_ID": "1DX996351" } }, "VISAS": { "CONTENU": "Le Premier ministre,
Sur le rapport du ministre du travail et des affaires sociales,
Vu le code de la santé publique, notamment les articles L. 512, L. 567-2, L. 567-9, L. 666-8, L. 761-14-1 et R. 5000 ;
Vu la loi no 93-5 du 4 janvier 1993 relative à la sécurité en matière de transfusion sanguine et de médicament, notamment l'article 19, modifié par la loi no 94-43 du 18 janvier 1994 relative à la santé publique et à la protection sociale ;
Vu l'avis de la Commission nationale permanente de biologie médicale en date du 8 mars 1994 ;
Le Conseil d'Etat (section sociale) entendu,
Décrète :
\n
" }, "SIGNATAIRES": { "CONTENU": "Fait à Paris, le 19 avril 1996.
\n

Alain Juppé

Par le Premier ministre :

Le ministre du travail et des affaires sociales,
Jacques Barrot

Le garde des sceaux, ministre de la justice,

Jacques Toubon

Le ministre de l'économie et des finances,
Jean Arthuis

Le ministre de l'industrie, de la poste

et des télécommunications,

Franck Borotra

Le ministre délégué au budget,
porte-parole du Gouvernement,
Alain Lamassoure

Le ministre délégué aux finances

et au commerce extérieur,

Yves Galland

Le secrétaire d'Etat à la santé et à la sécurité sociale,
Hervé Gaymard" } }, "JORFTEXT000000378518": { "SM": { "CONTENU": "NOMINATION DE MEMBRES TITULAIRES ET SUPPLEANTS:
EN QUALITE DE PERSONNALITES CHOISIES EN RAISON DE LEUR COMPETENCE SCIENTIFIQUE DANS CHACUNE DES DISCIPLINES DE BIOLOGIE MEDICALE;
EN QUALITE DE REPRESENTANTS DES ORGANISATIONS SYNDICALES ET PROFESSIONNELLES DE L'INDUSTRIE DES REACTIFS DE LABORATOIRE.
SONT NOMMES RESPECTIVEMENT PRESIDENT ET VICE-PRESIDENT DE LA COMMISSION: MM. DENIS (FRANCOIS) ET DELPECH MARC." }, "META": { "META_SPEC": { "META_TEXTE_VERSION": { "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000577884", "#text": "ARRETE", "@sens": "cible", "@cidtexte": "JORFTEXT000000577884", "@nortexte": "MESM9922571A", "@typelien": "MODIFIE", "@naturetexte": "ARRETE", "@datesignatexte": "1999-08-05" } ] }, "TITRE": "Arrêté du 7 août 1996", "MCS_TXT": { "MC": [ "TRAVAIL", "AFFAIRES SOCIALES", "SANG", "PRODUIT SANGUIN", "TRANSFUSION SANGUINE", "GROUPE SANGUIN", "REACTIF", "COMMISSION CONSULTATIVE D'ENREGISTREMENT DES REACTIFS", "ORGANISME CONSULTATIF", "AGENCE DU MEDICAMENT", "EPA", "PERSONNALITE COMPETENTE", "REACTIF DE LABORATOIRE", "BIOLOGIE MEDICALE", "MEMBRE", "MEMBRE TITULAIRE", "MEMBRE SUPPLEANT", "PRESIDENT", "VICE-PRESIDENT", "NOMINATION", "MESURE NOMINATIVE" ] }, "MINISTERE": "MINISTERE DU TRAVAIL ET DES AFFAIRES SOCIALES", "TITREFULL": "Arrêté du 7 août 1996 portant nomination à la commission consultative d'enregistrement des réactifs" }, 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