{ "texte_version": { "JORFTEXT000000887790": { "SM": { "CONTENU": "ABROGE PARTIELLEMENT LA DIRECTIVE 6565 CEE (ART. 13 A 20) DU 26-01-1966 CONCERNANT LE RAPPROCHEMENT DES DISPOSITIONS LEGISLATIVES,REGLEMENTAIRES ET ADMINISTRATIVES RELATIVES AUX SPECIALITES PHARMACEUTIQUES.
ABROGE PARTIELLEMENT LA DIRECTIVE 75319 CEE DU 20-05-1975 (ART. 6 ET 7)." }, "ABRO": { "CONTENU": "Texte totalement abrogé" }, "META": { "META_SPEC": { "META_TEXTE_VERSION": { "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000878797", "#text": "Directive 65/65/CEE du Conseil du 26 janvier 1965", "@sens": "source", "@cidtexte": "JORFTEXT000000878797", "@nortexte": "31965L0065", "@numtexte": "65-65", "@typelien": "MODIFIE", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1965-01-26" }, { "@id": "JORFTEXT000000878797", "#text": "Directive 65/65/CEE du Conseil du 26 janvier 1965", "@sens": "source", "@cidtexte": "JORFTEXT000000878797", "@nortexte": "31965L0065", "@numtexte": "65-65", "@typelien": "APPLICATION", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1965-01-26" }, { "@id": "JORFTEXT000000319780", "#text": "Directive Européenne n°75-318 du 20 mai 1975", "@sens": "source", "@cidtexte": "JORFTEXT000000319780", "@nortexte": "375L0318", "@numtexte": "75-318", "@typelien": "APPLICATION", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1975-05-20" }, { "@id": "JORFTEXT000000883144", "#text": "Directive Européenne n°75-319 du 20 mai 1975", "@sens": "source", "@cidtexte": "JORFTEXT000000883144", "@nortexte": "375L0319", "@numtexte": "75-319", "@typelien": "MODIFIE", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1975-05-20" }, { "@id": "JORFTEXT000000705748", "#text": "Directive Européenne n°93-39 du 14 juin 1993", "@sens": "cible", "@cidtexte": "JORFTEXT000000705748", "@nortexte": "393L0039", "@numtexte": "93-39", "@typelien": "APPLICATION", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1993-06-14" }, { "@id": "JORFTEXT000000180444", "#text": "DECRET94-19", "@sens": "cible", "@cidtexte": "JORFTEXT000000180444", "@nortexte": "SPSM9303267D", "@numtexte": "94-19", "@typelien": "APPLICATION", "@naturetexte": "DECRET", "@datesignatexte": "1994-01-05" }, { "@id": "JORFTEXT000000760194", "#text": "DECRET99-338", "@sens": "cible", "@cidtexte": "JORFTEXT000000760194", "@nortexte": "MESP9921159D", "@numtexte": "99-338", "@typelien": "APPLICATION", "@naturetexte": "DECRET", "@datesignatexte": "1999-05-03" }, { "@id": "JORFTEXT000000518889", "#text": "Directive Européenne n°2001-83 du 6 novembre 2001", "@sens": "cible", "@cidtexte": "JORFTEXT000000518889", "@nortexte": "32001L0083", "@numtexte": "2001-83", "@typelien": "ABROGE", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "2001-11-06" } ] }, "TITRE": "Directive Européenne n°92-27 du 31 mars 1992", "MCS_TXT": { "MC": [ "DIRECTIVE CEE", "SANTE PUBLIQUE", "INDUSTRIE PHARMACEUTIQUE", "MEDICAMENT", "SPECIALITE PHARMACEUTIQUE", "PHARMACOLOGIE", "COMMERCIALISATION", "DENOMINATION", "DOSAGE", "CONDITIONNEMENT", "EMBALLAGE", "ETIQUETAGE", "COMPOSITION", "NOTICE", "FABRICANT", "INFORMATION DU CONSOMMATEUR" ] }, "TITREFULL": "Directive Européenne n°92-27 du 31 mars 1992 N0 9227 CONCERNANT L'ETIQUETAGE ET LA NOTICE DES MEDICAMENTS A USAGE HUMAIN" }, "META_TEXTE_CHRONICLE": { "CID": "JORFTEXT000000887790", "NOR": "392L0027", "NUM": "92-27", "DATE_PUBLI": "1992-04-30", "DATE_TEXTE": "1992-03-31", "ORIGINE_PUBLI": "JOUE du 30 avril 1992", "PAGE_DEB_PUBLI": 8 } }, "META_COMMUN": { "ID": "JORFTEXT000000887790", "URL": "texte/version/JORF/TEXT/00/00/00/88/77/JORFTEXT000000887790.xml", "NATURE": "DIRECTIVE_EURO", "ORIGINE": "JORF", "ANCIEN_ID": "1RX99227EL113" } } }, "JORFTEXT000000180444": { "SM": { "CONTENU": "DEFINITION DANS UN ART. 5000 PLACE AVANT LE CHAP. I DU TITRE I DU LIVRE V DU CODE SUSVISE,DE DIFFERENTES EXPRESSIONS CONCERNANT LA DENOMINATION,LE DOSAGE,LE CONDITIONNEMENT,L'ETIQUETAGE ET LA NOTICE DES MEDICAMENTS.
LES FONCTIONS DES SERVICES D'INSPECTION COMPETENTS PREVUES A L'ART. R5056 SONT PRECISEES POUR CE QUI CONCERNE LES INSPECTIONS DES ETABLISSEMENTS PHARMACEUTIQUES: AJOUT D'UN AL..
ABROGATION DE L'ART. R5049 (DERNIER AL.).
MODIFIE L'ART. R5115-7 (DEBUT DE L'ART. ET AJOUT DE 3 AL.),REMPLACE L'ART. R5115-9 ET AJOUTE A LA FIN DU PARAG. 3 DE LA SECTION I DU CHAP. II DU TITRE II DU LIVRE V LES ART. R5115-10 ET R5115-11 EN VUE DE COMPLETER LES REGLES AUXQUELLES SERONT DESORMAIS SOUMISES LA FABRICATION ET L'IMPORTATION DE MEDICAMENTS EN VUE D'AMELIORER LA QUALITE ET LA SECURITE DE CES OPERATIONS.
REMPLACE L'INTITULE DE LA SECTION II DU CHAP. PRECITE: \"MEDICAMENTS ET PRODUITS SOUMIS A AUTORISATION\".LE CONTENU DE LA DEMANDE D'AMM ET CELUI DU RESUME DES CARACTERISTIQUES DU PRODUITPREVUS AUX ART. R5128 A R5129 SONT COMPLETES (INFORMATIONS SPECIFIQUES DANS LE CAS DE PRODUITS RADIO-PHARMACEUTIQUES): MODIFIE L'ART. R5128 (AL. 1: B ET C,AL. 2),L'ART. R5128-1 DEVIENT L'ART. R5128-2 Y MODIFIE (COMPLETE LA FIN DU O,LE T DEVIENT U ET INSERTION D'UN T APRES LE S); AJOUT DES ART. R5128-1,R5128-3 REMPLACE L'ART. R5129 (D).
LE CONTROLE DE L'AGENCE DU MEDICAMENT EST RENFORCE SUR LES TECHNIQUES DE CONTROLE ET LES METHODES DE FABRICATION LORS DE L'INSTRUCTION DU DOSSIER DU DEMANDEUR ET APRES LA DELIVRANCE DE L'AMM.AJOUT D'UN F A L'ART. R5134; REMPLACE L'ART. R5135-1 ET INSERE LES ART. R5135-2 ET R5135-3.
ART. R5135-4 AJOUTE ET ART. R5139 (AL. 3) REMPLACE.L'INTITULE DU PARAG. 3 DE LA SECTION II DU CHAP. PRECITE EST REMPLACE: \"ETIQUETAGE DES MEDICAMENTS OU PRODUITS SOUMIS A AUTORISATION\".REMPLACE L'ART. R5143,L'ART. R5143-1 DEVIENT L'ART. R5143-6 ET INSERTION DES ART. R5143-1 A R5143-3 AUQUEL EST AJOUTE UN PARAG. 4 (ART. R5143-4 ET R5143-5).CES ART. FIXANT LES DISPOSITIONSAPPLICABLES EN MATIERE D'ETIQUETAGE ET DE NOTICE DES MEDICAMENTS OU PRODUITS SOUMIS A L'AUTORISATION CORRESPONDENT A LA TRANSPOSITION LITTERALE DE LA DIRECTIVE 9227 CEE.UNE DISPOSITION RENDANT OBLIGATOIRE SUR L'ETIQUETAGE LA MENTION DU NUMERO AMM PERMETTANT DE VERIFIER SI UN MEDICAMENT SE TROUVE REGULIEREMENT AUTORISE: AJOUT D'UN PARAG. 5 APRES L'ART. R5143-5 (ART. R5143-6,R5143-7 ET R5144).L'ART. R5143-7 PREVOIT EN OUTRE L'ETABLISSEMENT PAR LE MINISTRE DE RECOMMANDATIONS SUR LES BONNES PRATIQUES D'ETIQUETAGE ET DE NOTICE AUXQUELLES DEVRA SE CONFORMER LE TITULAIRE DE L'AMM.
ENTREE EN VIGUEUR: A COMPTER DU PREMIER RENOUVELLEMENT QUINQUENNAL DE L'AMM OU A L'OCCASION DE TOUTE MODIFICATION DES MEDICAMENTS OU PRODUITS MENTIONNES A L'ART. L601 DU CODE,AUTORISES AU 09-01-1994.
TRANSPOSITION DES DIRECTIVES CEE 89341,89342,89343 ET 89381." }, "ABRO": { "CONTENU": "Texte totalement abrogé" }, "META": { "META_SPEC": { "META_TEXTE_VERSION": { "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000333568", "#text": "Directive Européenne n°89-341 du 3 mai 1989", "@sens": "source", "@cidtexte": "JORFTEXT000000333568", "@nortexte": "389L0341", "@numtexte": "89-341", "@typelien": "APPLICATION", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1989-05-03" }, { "@id": "JORFTEXT000000521040", "#text": "Directive Européenne n°89-343 du 3 mai 1989", "@sens": "source", "@cidtexte": "JORFTEXT000000521040", "@nortexte": "389L0343", "@numtexte": "89-343", "@typelien": "APPLICATION", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1989-05-03" }, { "@id": "JORFTEXT000000704962", "#text": "Directive Européenne n°89-342 du 3 mai 1989", "@sens": "source", "@cidtexte": "JORFTEXT000000704962", "@nortexte": "389L0342", "@numtexte": "89-342", "@typelien": "APPLICATION", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1989-05-03" }, { "@id": "JORFTEXT000000704964", "#text": "Directive Européenne n°89-381 du 14 juin 1989", "@sens": "source", "@cidtexte": "JORFTEXT000000704964", "@nortexte": "389L0381", "@numtexte": "89-381", "@typelien": "APPLICATION", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1989-06-14" }, { "@id": "JORFTEXT000000706089", "#text": "Directive Européenne n°91-356 du 13 juin 1991", "@sens": "source", "@cidtexte": "JORFTEXT000000706089", "@nortexte": "391L0356", "@numtexte": "91-356", "@typelien": "APPLICATION", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1991-06-13" }, { "@id": "JORFTEXT000000887790", "#text": "Directive Européenne n°92-27 du 31 mars 1992", "@sens": "source", "@cidtexte": "JORFTEXT000000887790", "@nortexte": "392L0027", "@numtexte": "92-27", "@typelien": "APPLICATION", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1992-03-31" }, { "@id": "JORFTEXT000000705748", "#text": "Directive Européenne n°93-39 du 14 juin 1993", "@sens": "source", "@cidtexte": "JORFTEXT000000705748", "@nortexte": "393L0039", "@numtexte": "93-39", "@typelien": "APPLICATION", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1993-06-14" }, { "@id": "LEGIARTI000006698619", "@num": "23", "#text": "Décret n°94-19 du 5 janvier 1994 - art. 23 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000180444", "@nortexte": "SPSM9303267D", "@numtexte": "94-19", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1994-01-05" }, { "@id": "JORFTEXT000000760194", "#text": "DECRET99-338", "@sens": "cible", "@cidtexte": "JORFTEXT000000760194", "@nortexte": "MESP9921159D", "@numtexte": "99-338", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "1999-05-03" }, { "@id": "LEGIARTI000006726135", "@num": "6", "#text": "Décret n°2004-802 du 29 juillet 2004 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000421679", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "JORFTEXT000000421679", "#text": "Décret2004-802", "@sens": "cible", "@cidtexte": "JORFTEXT000000421679", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" } ] }, "TITRE": "Décret n°94-19 du 5 janvier 1994", "MCS_TXT": { "MC": [ "AFFAIRES SOCIALES", "SANTE PUBLIQUE", "CODE DE LA SANTE PUBLIQUE", "PHARMACIE", "MEDICAMENT", "PRODUIT PHARMACEUTIQUE", "COMMERCIALISATION", "AUTORISATION DE MISE SUR LE MARCHE", "AMM", "EMBALLAGE", "ETIQUETAGE", "NOTICE", "PUBLICITE", "PROTECTION DU CONSOMMATEUR", "CONDITIONNEMENT", "DOSAGE", "CONTROLE SANITAIRE", "PRODUIT RADIO- PHARMACEUTIQUE", "INFORMATION SPECIFIQUE", "DROIT A L'INFORMATION", "TRANSPOSITION DE DIRECTIVE CE", "HARMONISATION EUROPEENNE", "RAPPROCHEMENT DE LEGISLATION", "AGENCE DU MEDICAMENT", "EPA" ] }, "MINISTERE": "MINISTERE DES AFFAIRES SOCIALES, DE LA SANTE ET DE LA VILLE", "TITREFULL": "Décret no 94-19 du 5 janvier 1994 portant transposition de directives communautaires relatives à la pharmacie et au médicament et modifiant le code de la santé publique (deuxième partie: Décrets en Conseil d'Etat)" }, "META_TEXTE_CHRONICLE": { "CID": "JORFTEXT000000180444", "NOR": "SPSM9303267D", "NUM": "94-19", "DATE_PUBLI": "1994-01-09", "DATE_TEXTE": "1994-01-05", "ORIGINE_PUBLI": "JORF n°7 du 9 janvier 1994", "PAGE_DEB_PUBLI": 557, "PAGE_FIN_PUBLI": 19940109 } }, "META_COMMUN": { "ID": "JORFTEXT000000180444", "URL": "texte/version/JORF/TEXT/00/00/00/18/04/JORFTEXT000000180444.xml", "ID_ELI": "https://www.legifrance.gouv.fr/eli/decret/1994/1/5/SPSM9303267D/jo/texte", "NATURE": "DECRET", "ORIGINE": "JORF", "ANCIEN_ID": "1DX99419", "ELI_ALIAS": { "ID_ELI_ALIAS": "https://www.legifrance.gouv.fr/eli/decret/1994/1/5/94-19/jo/texte" } } }, "VISAS": { "CONTENU": "Le Premier ministre,
Sur le rapport du ministre d'Etat, ministre des affaires sociales, de la santé et de la ville, et du ministre délégué à la santé,
Vu la directive (C.E.E.) no 89-341 du conseil du 3 mai 1989 modifiant les directives (C.E.E) no 65-65 du 26 janvier 1965, (C.E.E) nos 75-318 et (C.E.E.) 75-319 du 20 mai 1975 concernant le rapprochement des dispositions législatives, réglementaires et administratives relatives aux spécialités pharmaceutiques;
Vu la directive (C.E.E.) no 89-342 du conseil du 3 mai 1989 élargissant le champ d'application des directives (C.E.E.) no 65-65 et (C.E.E.) no 75-319 et prévoyant des dispositions complémentaires pour les médicaments immunologiques consistant en vaccins, toxines, sérums ou allergènes;
Vu la directive (C.E.E.) no 89-343 du conseil du 3 mai 1989 élargissant le champ d'application des directives (C.E.E.) no 65-65 et (C.E.E.) no 75-319 et prévoyant des dispositions complémentaires pour les médicaments radiopharmaceutiques;
Vu la directive (C.E.E.) no 91-356 de la commission du 13 juin 1991 établissant les principes et lignes directrices de bonnes pratiques de fabrication pour les médicaments à usage humain;
Vu la directive (C.E.E.) no 92-27 du conseil du 31 mars 1992 concernant l'étiquetage et la notice des médicaments à usage humain;
Vu la directive du conseil (C.E.E.) no 93-39 du 14 juin 1993 modifiant les directives (C.E.E.) no 65-65, (C.E.E.) no 75-318 et (C.E.E) no 75-319;
Vu le code de la santé publique, notamment son livre V;
Le Conseil d'Etat (section sociale) entendu,
Décrète:
\n
" }, "SIGNATAIRES": { "CONTENU": "Fait à Paris, le 5 janvier 1994.
\n

EDOUARD BALLADUR

Par le Premier ministre:

Le ministre d'Etat, ministre des affaires sociales,
de la santé et de la ville,
SIMONE VEIL

Le ministre délégué à la santé,

PHILIPPE DOUSTE-BLAZY

" } }, "JORFTEXT000000319780": { "ABRO": { "CONTENU": "Texte totalement abrogé" }, "META": { "META_SPEC": { "META_TEXTE_VERSION": { "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000669499", "#text": "Arrêté du 26 juin 1972", "@sens": "cible", "@cidtexte": "JORFTEXT000000669499", "@typelien": "APPLICATION", "@naturetexte": "ARRETE", "@datesignatexte": "1972-06-26" }, { "@id": "JORFTEXT000000640463", "#text": "Arrêté du 16 décembre 1975", "@sens": "cible", "@cidtexte": "JORFTEXT000000640463", "@typelien": "APPLICATION", "@naturetexte": "ARRETE", "@datesignatexte": "1975-12-16" }, { "@id": "JORFTEXT000000291636", "#text": "Arrêté du 10 août 1976", "@sens": "cible", "@cidtexte": "JORFTEXT000000291636", "@typelien": "APPLICATION", "@naturetexte": "ARRETE", "@datesignatexte": "1976-08-10" }, { "@id": "JORFTEXT000000307595", "#text": "Décret n°78-988 du 20 septembre 1978", "@sens": "cible", "@cidtexte": "JORFTEXT000000307595", "@numtexte": "78-988", "@typelien": "APPLICATION", "@naturetexte": "DECRET", "@datesignatexte": "1978-09-20" }, { "@id": "JORFTEXT000000706116", "#text": "Directive Européenne n°83-570 du 26 octobre 1983", "@sens": "cible", "@cidtexte": "JORFTEXT000000706116", "@nortexte": "383L0570", "@numtexte": "83-570", "@typelien": "MODIFIE", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1983-10-26" }, { "@id": "JORFTEXT000000320940", "#text": "Directive Européenne n°87-19 du 22 décembre 1986", "@sens": "cible", "@cidtexte": "JORFTEXT000000320940", "@nortexte": "387L0019", "@numtexte": "87-19", "@typelien": "MODIFIE", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1986-12-22" }, { "@id": "JORFTEXT000000333568", "#text": "Directive Européenne n°89-341 du 3 mai 1989", "@sens": "cible", "@cidtexte": "JORFTEXT000000333568", "@nortexte": "389L0341", "@numtexte": "89-341", "@typelien": "MODIFIE", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1989-05-03" }, { "@id": "JORFTEXT000000535308", "#text": "LOI91-73", "@sens": "cible", "@cidtexte": "JORFTEXT000000535308", "@nortexte": "SPSX9000173L", "@numtexte": "91-73", "@typelien": "APPLICATION", "@naturetexte": "LOI", "@datesignatexte": "1991-01-18" }, { "@id": "JORFTEXT000000706089", "#text": "Directive Européenne n°91-356 du 13 juin 1991", "@sens": "cible", "@cidtexte": "JORFTEXT000000706089", "@nortexte": "391L0356", "@numtexte": "91-356", "@typelien": "APPLICATION", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1991-06-13" }, { "@id": "JORFTEXT000000887660", "#text": "Directive Européenne n°91-507 du 19 juillet 1991", "@sens": "cible", "@cidtexte": "JORFTEXT000000887660", "@nortexte": "391L0507", "@numtexte": "91-507", "@typelien": "MODIFIE", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1991-07-19" }, { "@id": "JORFTEXT000000887790", "#text": "Directive Européenne n°92-27 du 31 mars 1992", "@sens": "cible", "@cidtexte": "JORFTEXT000000887790", "@nortexte": "392L0027", "@numtexte": "92-27", "@typelien": "APPLICATION", "@naturetexte": "DIRECTIVE_EURO", 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"@sens": "cible", "@cidtexte": "JORFTEXT000000518889", "@nortexte": "32001L0083", "@numtexte": "2001-83", "@typelien": "ABROGE", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "2001-11-06" } ] }, "TITRE": "Directive Européenne n°75-318 du 20 mai 1975", "MCS_TXT": { "MC": [ "SANTE PUBLIQUE", "PHARMACIE", "INDUSTRIE PHARMACEUTIQUE", "MEDICAMENT", "ESSAI", "DIRECTIVE CEE", "TOXICOLOGIE", "ANALYSE", "EXPERIENCE", "RECHERCHE", "RAPPROCHEMENT DE LEGISLATION", "PHARMACOLOGIE", "NORME", "SPECIALITE PHARMACEUTIQUE" ] }, "TITREFULL": "Directive Européenne n°75-318 du 20 mai 1975 NO 75318 RELATIVE AU RAPPROCHEMENT DES LEGISLATIONS DES ETATS MEMBRES CONCERNANT LES NORMES ET PROTOCOLES ANALYTIQUES,TOXICO-PHARMACOLOGIQUES ET CLINIQUES EN MATIERE D'ESSAIS DE SPECIALITES PHARMACEUTIQUES" }, "META_TEXTE_CHRONICLE": { "CID": "JORFTEXT000000319780", "NOR": "375L0318", "NUM": "75-318", "DATE_PUBLI": "1975-06-09", "DATE_TEXTE": "1975-05-20", "ORIGINE_PUBLI": "JOCE du 9 juin 1975", "PAGE_DEB_PUBLI": 1 } }, "META_COMMUN": { "ID": "JORFTEXT000000319780", "URL": "texte/version/JORF/TEXT/00/00/00/31/97/JORFTEXT000000319780.xml", "NATURE": "DIRECTIVE_EURO", "ORIGINE": "JORF", "ANCIEN_ID": "1RX975318EL147" } } }, "JORFTEXT000000518889": { "SM": { "CONTENU": "La présente directive entre en vigueur le 18-12-2001. \nModification de la présente directive par le Règlement délégué (UE) n° 1252/2014 de la Commission du 28 mai 2014 complétant la directive 2001/83/CE du Parlement européen et du Conseil en ce qui concerne les principes et lignes directrices de bonnes pratiques de fabrication des substances actives des médicaments à usage humain (JOUE L337 du 25-11-2014 p.1) ; le Règlement délégué (UE) 2016/161 de la Commission du 2 octobre 2015 complétant la directive 2001/83/CE du Parlement européen et du Conseil en fixant les modalités des dispositifs de sécurité figurant sur l'emballage des médicaments à usage humain (JOUE L32 du 8 février 2016 p.1) ; le Règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux, modifiant la directive 2001/83/CE, le règlement (CE) no 178/2002 et le règlement (CE) no 1223/2009 et abrogeant les directives du Conseil 90/385/CEE et 93/42/CEE (JOUE L117 p.1) ; le Règlement (UE) 2019/5 du Parlement européen et du Conseil du 11 décembre 2018 modifiant le règlement (CE) no 726/2004 établissant des procédures communautaires pour l’autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments, le règlement (CE) no 1901/2006 relatif aux médicaments à usage pédiatrique et la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain (JOUE L4 du 7 janvier 2019, p. 24)." }, "META": { "META_SPEC": { "META_TEXTE_VERSION": { "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000878797", "#text": "Directive 65/65/CEE du Conseil du 26 janvier 1965", "@sens": "source", "@cidtexte": 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LE PRESENT DECRET A POUR OBJET D'AMELIORER LA PREVENTION DES RISQUES QUE FONT COURIR AUX CONDUCTEURS DE VEHICULES ET AUX UTILISATEURS DE MACHINES LA CONSOMMATION DE MEDICAMENTS CONTENANT DES SUBSTANCES SUSCEPTIBLES D'ENTRAINER UNE BAISSE DE VIGILANCE OU UNE SOMNOLENCE.
IL PREVOIT A CET EFFET L'APPOSITION OBLIGATOIRE D'UN PICTOGRAMME SUR LE CONDITIONNEMENT EXTERIEUR DES MEDICAMENTS PRECITES AFIN D'OPTIMISER L'INFORMATION DES PROFESSIONNELS DE SANTE ET DES CONSOMMATEURS A DES FINS DE BON USAGE.
CETTE PROPOSITION S'INSCRIT NOTAMMENT DANS LE CADRE DE L'EFFORT ENGAGE PAR LE GOUVERNEMENT EN VUE DE DETERMINER LE NOMBRE DES VICTIMES DES ACCIDENTS DE LA ROUTE ET FAIT SUITE AU RAPPORT RENDU EN MARS 1996 PAR LE PROFESSEUR ZARIFIAN SUR LA PRESCRIPTION ET L'UTILISATION DES MEDICAMENTS PSYCHOTROPES EN FRANCE.
ACTUELLEMENT,L'ART. R5143 DU CODE PRECITE PREVOIT LA POSSIBILITE D'APPOSER UN PICTOGRAMME SUR LE CONDITIONNEMENT EXTERIEUR DES MEDICAMENTS OU PRODUITS SOUMIS A AUTORISATION.
CET ART. A ETE INTRODUIT DANS LE CODE SUSVISE PAR LE DECRET 9419 DU 05-01-1994 QUI A TRANSPOSE LA DIRECTIVE 9227 CEE DU CONSEIL DES COMMUNAUTES EUROPEENNES DU 31-03-1992 CONCERNANT L'ETIQUETAGE ET LA NOTICE DES MEDICAMENTS A USAGE HUMAIN.
LE DECRET REND DESORMAIS OBLIGATOIRE L'APPOSITION D'UN PICTOGRAMME SUR LE CONDITIONNEMENT EXTERIEUR DES MEDICAMENTS PRESENTANT LES EFFETS PRECITES.
LE MODELE DE CE PICTOGRAMME SERA DETERMINE PAR ARRETE DU MINISTRE CHARGE DE LA SANTE EN CONCERTATION AVEC LES PARTENAIRES INDUSTRIELS CONCERNES.
UNE NOTE EXPLICATIVE PREPAREE PAR LE GROUPE DE TRAVAIL \"NOTICE-ETIQUETAGE\" DE LA COMMISSION EUROPEENNE PRECISE QUE DES PICTOGRAMMES SONT ACTUELLEMENT OBLIGATOIREMENT APPOSES EN AUTRICHE,AU DANEMARK,EN FINLANDE ET EN SUEDE SUR LE CONDITIONNEMENT DES MEDICAMENTS CONTENANT DES SUBSTANCES SUSCEPTIBLES D'ENTRAINER UNE SOMNOLENCE.IL A ETE CONSIDERE QUE CES SPECIFICITES NATIONALES N'ETAIENT PAS CONTRAIRES AUX DISPOSITIONS DE L'ART. 2-2 DE LA DIRECTIVE 9227 PRECITEE.
LE DECRET PREVOIT DANS SON ART. 2 UN DISPOSITIF TRANSITOIRE DONNANT AU TITULAIRE DE L'AUTORISATION DE MISE SUR LE MARCHE UN DELAI DE 2 ANS POUR APPOSER LE PICTOGRAMME,A COMPTER DU 05-05- 1999.
CEPENDANT,LE PICTOGRAMME DEVRA ETRE APPOSE AVANT LE DELAI PRECITE EN CAS DE RENOUVELLEMENT DE L'AUTORISATION DE MISE SUR LE MARCHE OU DE MODIFICATION DES ELEMENTS DE CETTE AUTORISATION.
IL EST PAR AILLEURS PRECISE QUE LES MESURES DE SUSPENSION DES AUTORISATIONS DE MISE SUR LE MARCHE PREVUES A L'ART. R5139 DU CODE PRECITE SONT APPLICABLES EN CAS DE NON RESPECT DES DISPOSITIONS DE L'ART. 2." }, "ABRO": { "CONTENU": "Texte totalement abrogé" }, "META": { "META_SPEC": { "META_TEXTE_VERSION": { "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000887790", "#text": "Directive Européenne n°92-27 du 31 mars 1992", "@sens": "source", "@cidtexte": "JORFTEXT000000887790", "@nortexte": "392L0027", "@numtexte": "92-27", "@typelien": "APPLICATION", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1992-03-31" }, { "@id": "JORFTEXT000000180444", "#text": "Décret n°94-19 du 5 janvier 1994", "@sens": "source", "@cidtexte": "JORFTEXT000000180444", "@nortexte": "SPSM9303267D", "@numtexte": "94-19", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "1994-01-05" }, { "@id": "LEGIARTI000006726135", "@num": "6", "#text": "Décret n°2004-802 du 29 juillet 2004 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000421679", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "JORFTEXT000000421679", "#text": "Décret2004-802", "@sens": "cible", "@cidtexte": "JORFTEXT000000421679", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" } ] }, "TITRE": "Décret n°99-338 du 3 mai 1999", "MCS_TXT": { "MC": [ "EMPLOI", "SOLIDARITE", "SANTE PUBLIQUE", "CODE DE LA SANTE PUBLIQUE", "MEDICAMENT", "MEDICAMENT PSYCHOTROPE", "CONSOMMATION", "PROTECTION DU CONSOMMATEUR", "UTILISATION", "PRESCRIPTION", "MESURE PREVENTIVE", "CONDUCTEUR", "VEHICULE", "UTILISATEUR DE MACHINE", "CONDITIONNEMENT", "PRODUIT MEDICAMENTEUX", "APPOSITION", "PICTOGRAMME", "DELAI", "AUTORISATION DE MISE SUR LE MARCHE", "AMM", "SANCTION PENALE", "TRANSPOSITION DE DIRECTIVE CE" ] }, "MINISTERE": "MINISTERE DE L'EMPLOI ET DE LA SOLIDARITE", "TITREFULL": "Décret no 99-338 du 3 mai 1999 relatif à l'apposition d'un pictogramme sur le conditionnement extérieur de certains médicaments ou produits et modifiant le code de la santé publique (deuxième partie : Décrets en Conseil d'Etat)" }, "META_TEXTE_CHRONICLE": { "CID": "JORFTEXT000000760194", "NOR": "MESP9921159D", "NUM": "99-338", "DATE_PUBLI": "1999-05-05", "DATE_TEXTE": "1999-05-03", "ORIGINE_PUBLI": "JORF n°104 du 5 mai 1999", "PAGE_DEB_PUBLI": 6725, "PAGE_FIN_PUBLI": 6726 } }, "META_COMMUN": { "ID": "JORFTEXT000000760194", "URL": "texte/version/JORF/TEXT/00/00/00/76/01/JORFTEXT000000760194.xml", "ID_ELI": "https://www.legifrance.gouv.fr/eli/decret/1999/5/3/MESP9921159D/jo/texte", "NATURE": "DECRET", "ORIGINE": "JORF", "ANCIEN_ID": "1DX999338", "ELI_ALIAS": { "ID_ELI_ALIAS": "https://www.legifrance.gouv.fr/eli/decret/1999/5/3/99-338/jo/texte" } } }, "VISAS": { "CONTENU": "

Le Premier ministre,

Sur le rapport de la ministre de l'emploi et de la solidarité,

Vu la directive 92/27/CEE du Conseil du 31 mars 1992 concernant l'étiquetage et la notice des médicaments à usage humain, notamment l'article 2-2 ;

Vu le code de la santé publique, notamment les articles L. 601 et L. 605 ;

Le Conseil d'Etat (section sociale) entendu,

Décrète :

" }, "SIGNATAIRES": { "CONTENU": "

Fait à Paris, le 3 mai 1999.

Lionel Jospin

Par le Premier ministre :

La ministre de l'emploi et de la solidarité,

Martine Aubry

Le secrétaire d'Etat à la santé

et à l'action sociale,

Bernard Kouchner

" } }, "JORFTEXT000000878797": { "SM": { "CONTENU": "Rectificatif (suite) : JOCE n°229 du 15 août 1986 p.63" }, "ABRO": { "CONTENU": "Texte totalement abrogé" }, "META": { "META_SPEC": { "META_TEXTE_VERSION": { "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000510265", "#text": "Directive Européenne n°66-454 du 28 juillet 1966", "@sens": "cible", "@cidtexte": "JORFTEXT000000510265", "@nortexte": "366L0454", "@numtexte": "66-454", "@typelien": "MODIFIE", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1966-07-28" }, { "@id": "JORFTEXT000000699941", "#text": "Ordonnance n°67-827 du 23 septembre 1967", "@sens": "cible", "@cidtexte": "JORFTEXT000000699941", "@numtexte": "67-827", "@typelien": "APPLICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1967-09-23" }, { "@id": "JORFTEXT000000518702", "#text": "Décret n°72-1062 du 21 novembre 1972", "@sens": "cible", "@cidtexte": "JORFTEXT000000518702", "@numtexte": "72-1062", "@typelien": "APPLICATION", "@naturetexte": "DECRET", 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