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I. L'historique des législations américaine, japonaise et européenne - II. Le statut de médicament orphelin - III. L'autorisation de mise sur le marché - IV. Mesures et procédures incitatives

Médicament --- Maladie --- BPB1103 --- Geneesmiddel --- Ziekte --- betegség --- ziekte --- boli --- haigus --- illness --- choroba --- liga --- sygdom --- sairaus --- sjukdom --- bolezen --- enfermedad --- doença --- Krankheit --- sëmundje --- bolest --- malattia --- nemoc --- ασθένεια --- marda --- slimība --- болест --- saslimstība --- stonání --- akutní nemoc --- Erkrankung --- πάθηση --- neléčitelná choroba --- disease --- νόσος --- αρρώστεια --- onemocnění --- affection --- neduh --- morbo --- megbetegedés --- slimošana --- νόσημα --- ravim --- lék --- lääke --- lijek --- mediċinament --- φάρμακα --- medicamento --- läkemedel --- лек --- medicament --- лекарство --- lek --- liek --- medicinale --- geneesmiddel --- medicamente --- Medikament --- gyógyszer --- medikament --- zdravilo --- vaistinis preparatas --- medikaments --- kapky --- orvosság --- medicamento per la medicina animale --- medicamento per la medicina umana --- zásyp --- medication --- mast --- tabletka --- vaistas --- Arznei --- tinktura --- mjekim --- lääkintä --- léčivý přípravek --- медикамент --- prášky --- prášek --- liečivý prípravok --- lääkitys --- îngrijire medicală --- dražé --- Arzneispezialität --- tableta --- čípek --- Arzneimittel --- Organen Dienst voor geneeskundige verzorging : College van geneesheren voor weesgeneesmiddelen --- Geneeskundige verstrekkingen (in de enge zin) : Farmaceutische producten --- лекарствен продукт --- medicin --- medikamentas --- zāles --- prodotti mediċinali --- produkt leczniczy --- lægemiddel --- remédio --- médicament --- lääkevalmiste --- prodotto medicinale --- medicijn --- Organes Service des soins de santé : Collège des médecins pour des médicaments orphelins --- Prestations de santé (au sens strict) : Produits pharmaceutiques --- prodott mediċinali --- φάρμακο --- medicinski proizvod --- medicinal product --- gyógyászati készítmény --- tinneas --- íoc leighis --- Droit médical --- Etats-Unis --- Japon --- France --- Médicament --- maladie --- Läkemedelsprodukter

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Les biomédicaments représentent une véritable révolution dans la prise en charge des maladies et des patients. Ils permettent de soigner, ou d'envisager de soigner à moyen terme, des pathologies graves que l'arsenal thérapeutique chimique traditionnel ne parvient pas toujours à traiter. Grâce à la connaissance sans cesse améliorée de la génétique et du fonctionnement des cellules, les scientifiques savent désormais concevoir des outils de soin plus ciblés. D'ores et déjà, ce sont 325 millions de patients qui ont bénéficié des biomédicaments tels que les interférons, les hormones recombi-nantes, les anticorps humanisés, ou encore les vaccins thérapeutiques ou préventifs. Cet ouvrage explique ce que sont les biomédicaments, et par extension les biothérapies. Il montre combien cette nouvelle approche de la médecine est porteuse d'avenir.

Biopharmaceutics --- Medical ethics --- Biopharmacie --- Ethique médicale --- Pharmaceutical biotechnology --- Pharmaceutical biotechnology industry --- Biological products --- Biotechnology --- Economic aspects --- Therapeutic use --- BPB1210 --- Médicament --- Génétique --- Geneesmiddel --- Genetica --- Ethique médicale --- perinnöllisyystiede --- ģenētika --- genetică --- genetics --- genetik --- genética --- geneetika --- генетика --- genetica --- géineolaíocht --- genetika --- gjenetikë --- ġenetika --- genetyka --- Genetik --- γενετική --- наследност --- genski vir --- heredity --- hérédité --- genetické zdroje --- arvelig faktor --- Gene --- génkészlet --- ereditarietà --- genetiska resurser --- patrimoine génétique --- risorsa genetica --- recurso genético --- genetische rijkdom --- iedzimtība --- burim gjenetik --- arvsmassa --- dziedzictwo genetyczne --- geenivarat --- genų fondas --- ereditate --- genofonds --- genotip --- arveanlæg --- Genbestand --- perintöaines --- ген --- genotyp --- ģenētiskie resursi --- genetikai forrás --- γενετικοί πόροι --- génállomány --- gén --- genotype --- генотип --- genetikai örökség --- genotips --- genetic resource --- ärftlighetslära --- herencia genética --- genotipas --- Vererbung --- genetiskt arv --- material gjenetik --- ģenētiskais materiāls --- genski sklad --- genetika populace --- γενετική κληρονομιά --- genetische Ressource --- hereditariedade --- paveldimumas --- património genético --- genetisch erfgoed --- genetisches Erbgut --- génové zdroje --- genų ištekliai --- perinnöllisyys --- genofond --- geneetiline ressurss --- genressourcer --- genetisk resurs --- gene pool --- genetsko nasljedstvo --- genetiniai ištekliai --- geeniperimä --- gjenotip --- erfelijkheid --- örökléstan --- κληρονομικότητα --- genotípus --- gjene --- patrimonio genetico --- pärilikkus --- genressource --- genetisch materiaal --- genotüüp --- ressource génétique --- genetic stock --- patrimonio genético --- genetinis paveldas --- ravim --- lék --- lääke --- lijek --- mediċinament --- φάρμακα --- medicamento --- läkemedel --- лек --- medicament --- лекарство --- lek --- liek --- medicinale --- geneesmiddel --- medicamente --- Medikament --- gyógyszer --- medikament --- zdravilo --- vaistinis preparatas --- medikaments --- kapky --- orvosság --- medicamento per la medicina animale --- medicamento per la medicina umana --- zásyp --- medication --- mast --- tabletka --- vaistas --- Arznei --- tinktura --- mjekim --- lääkintä --- léčivý přípravek --- медикамент --- prášky --- prášek --- liečivý prípravok --- lääkitys --- îngrijire medicală --- dražé --- Arzneispezialität --- tableta --- čípek --- Arzneimittel --- лекарствен продукт --- medicin --- medikamentas --- zāles --- prodotti mediċinali --- produkt leczniczy --- lægemiddel --- remédio --- médicament --- lääkevalmiste --- prodotto medicinale --- medicijn --- prodott mediċinali --- φάρμακο --- medicinski proizvod --- medicinal product --- gyógyászati készítmény --- íoc leighis --- Pharmaceutical biotechnology - Economic aspects --- Biological products - Therapeutic use --- Génétique --- Médicament --- Läkemedelsprodukter

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Contrefaçon de médicaments --- Médicament --- Geneesmiddel --- Volksgezondheid --- BPB1201 --- Union européenne --- Santé publique --- Europese unie --- Medical law --- Criminal law. Criminal procedure --- European law --- rahvatervis --- shëndet publik --- обществено здраве --- zdraví veřejnosti --- public health --- volksgezondheid --- veselības aizsardzība --- javno zdravje --- közegészség --- saħħa pubblika --- sanità pubblica --- јавно здравје --- salud pública --- saúde pública --- Volksgesundheit --- kansanterveys --- јавно здравље --- zdrowie publiczne --- sláinte phoiblí --- javno zdravstvo --- sănătate publică --- folkhälsa --- offentlig sundhed --- δημόσια υγεία --- visuomenės sveikata --- zdravie verejnosti --- zdravie obyvateľstva --- gezondheid van de bevolking --- υγεία του πληθυσμού --- Закон за јавно здравје --- befolkningens hälsa --- gyventojų sveikata --- salute della popolazione --- zdraví lidu --- јавни здравствени установи --- népegészségügy --- santé de la population --- sănătate populație --- saúde da população --- здравјето на населението --- javno zdravlje --- sanidad pública --- shëndet i popullatës --- здравство --- health of the population --- zdraví obyvatelstva --- väestön terveydentila --- rahva tervis --- zdraví národa --- јавно ветеринарно здравство --- iedzīvotāju veselība --- befolkningssundhed --- veřejné zdraví --- ravim --- lék --- lääke --- lijek --- mediċinament --- φάρμακα --- medicamento --- läkemedel --- лек --- medicament --- лекарство --- lek --- liek --- medicinale --- geneesmiddel --- medicamente --- Medikament --- gyógyszer --- medikament --- zdravilo --- vaistinis preparatas --- medikaments --- kapky --- orvosság --- medicamento per la medicina animale --- medicamento per la medicina umana --- zásyp --- лекарствен продукт --- medication --- mast --- tabletka --- medicin --- vaistas --- medikamentas --- Arznei --- tinktura --- zāles --- prodotti mediċinali --- mjekim --- produkt leczniczy --- lääkintä --- lægemiddel --- léčivý přípravek --- медикамент --- prášky --- prášek --- remédio --- liečivý prípravok --- médicament --- lääkitys --- îngrijire medicală --- lääkevalmiste --- prodotto medicinale --- dražé --- medicijn --- Arzneispezialität --- tableta --- čípek --- Arzneimittel --- Europese Unie --- Europska unija --- União Europeia --- Ευρωπαϊκή Ένωση --- Európska únia --- Európai Unió --- Europäische Union --- Europos Sąjunga --- Evropská unie --- Европска унија --- Unjoni Ewropea --- Европейски съюз --- Europeiska unionen --- European Union --- Euroopan unioni --- Eiropas Savienība --- Unión Europea --- Evropska unija --- Unia Europejska --- Unione europea --- Uniunea Europeană --- Den Europæiske Union --- Европска Унија --- Euroopa Liit --- an tAontas Eorpach --- Bashkimi Europian --- Sąjungos institucija --- Sąjungos teisė --- právo Únie --- νόμος της Ένωσης --- Savienības tiesības --- wet van de Unie --- legge dell'Unione --- Europæisk Union --- unionslagstiftning --- atto dell'Unione --- AE --- loi de l'Union --- EU --- e drejta e Bashkimit --- ЕУ --- lege a Uniunii Europene --- Union law --- prodott mediċinali --- φάρμακο --- medicinski proizvod --- medicinal product --- gyógyászati készítmény --- íoc leighis --- Santé publique --- Union européenne --- Médicament --- Läkemedelsprodukter

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"While advertising of pharmaceuticals is highly regulated and fully harmonized in the European Union, there are no specific European rules on advertising of medical devices. The reasoning that led to the adoption of the rules on advertising of pharmaceuticals can nonetheless also be applied to medical devices: The current national rules on advertising of medical devices are widely divergent, hindering the establishment of the internal market of medical devices.Taking this idea as a point of departure, the main objective of the research is to formulate principles to underpin European regulation on advertising of medical devices. The basic assumption is that such regulation should allow a maximum of information to be communicated to the consumer, without compromising on health protection. To discern these principles, medical device law is being compared to pharmaceutical law and European and Belgian law, as well as US regulation are being investigated."

Medical law --- Pharmacology. Therapy --- Advertising. Public relations --- Belgium --- Public health laws --- European law --- Handbooks, manuals, etc. --- Medical instruments and apparatus industry --- BPB1712 --- Médicament --- Publicité --- Droit médical --- Geneesmiddel --- Reclame --- Medisch recht --- Médicaments --- Médecine --- Matériel médical --- Appareil et matériel --- Droit --- Appareil et matériel. --- E-books --- diritto sanitario --- право в областта на здравеопазването --- medicinsko pravo --- medisch recht --- medicinos teisė --- Derecho médico --- orvosi jog --- ιατρικό δίκαιο --- drept medical --- Medizinrecht --- lékařské právo --- medical law --- prawo ochrony zdrowia --- liġi medika --- medicīniskās tiesības --- medicinsk rätt --- medicinsk jura --- meditsiiniõigus --- lääketieteellinen lainsäädäntö --- direito médico --- e drejtë mjekësore --- медицинско право --- lekárske právo --- législation médicale --- lékařské zákony --- законодавство од областа на медицината --- Arztrecht --- Derecho sanitario --- lékařská legislativa --- Ärzterecht --- lékařskoprávní legislativa --- reklám --- reklamar --- reklame --- διαφήμιση --- mainonta --- publicidade --- рекламирање --- reklama --- reclame --- pubblicità --- огласување --- reklamavimas --- publicitet --- reklaam --- oglaševanje --- propagace --- reklam --- advertising --- publicitate --- oglašavanje --- fógraíocht --- publicidad --- reklāma --- реклама --- Werbung --- campanie publicitară --- reklamos kampanija --- пропагандна порака --- réclame --- reklāmas kampaņa --- reklamní kampaň --- mainoskampanja --- publiciteit --- διαφημιστική πληροφόρηση --- publicidad comercial --- publicidade comercial --- advertising campaign --- Werbeinformation --- hospodářská reklama --- reklamná kampaň --- lancio pubblicitario --- informação publicitária --- kommerciel reklame --- kommersiell reklam --- annoncekampagne --- reklamna kampanja --- annuncio pubblicitario --- Werbekampagne --- campanha publicitária --- campagna pubblicitaria --- reclameactie --- διαφημιστική προώθηση --- reklamiranje --- Werbefeldzug --- Reklame --- reklama (produkt) --- informazione pubblicitaria --- reklamní akce --- Werbeanzeige --- publicité commerciale --- commerciële reclame --- reklamekampagne --- reklamní inzerce --- advertisement --- manifesti --- propaganda publicitaria --- information publicitaire --- reklaamimine --- fushatë reklamash --- información publicitaria --- kereskedelmi hirdetés --- inzerce --- Werbeaktion --- ЕПП --- reklameinformation --- oglas --- advertentie --- reklamkampanj --- reclamecampagne --- pubblicità commerciale --- оглас --- reklaamikampaania --- campagne publicitaire --- mainos --- reclamă --- annonsering --- Wirtschaftswerbung --- campaña publicitaria --- reklamë --- εμπορική προβολή --- reklamní informace --- ravim --- lék --- lääke --- lijek --- mediċinament --- φάρμακα --- medicamento --- läkemedel --- лек --- medicament --- лекарство --- lek --- liek --- medicinale --- geneesmiddel --- medicamente --- Medikament --- gyógyszer --- medikament --- zdravilo --- vaistinis preparatas --- medikaments --- kapky --- orvosság --- medicamento per la medicina animale --- medicamento per la medicina umana --- zásyp --- medication --- mast --- tabletka --- vaistas --- Arznei --- tinktura --- mjekim --- lääkintä --- léčivý přípravek --- медикамент --- prášky --- prášek --- liečivý prípravok --- lääkitys --- îngrijire medicală --- dražé --- Arzneispezialität --- tableta --- čípek --- Arzneimittel --- лекарствен продукт --- medicin --- medikamentas --- zāles --- prodotti mediċinali --- produkt leczniczy --- lægemiddel --- remédio --- médicament --- lääkevalmiste --- prodotto medicinale --- medicijn --- Geneeskundige verstrekkingen (in de enge zin) : Farmaceutische producten --- Prestations de santé (au sens strict) : Produits pharmaceutiques --- prodott mediċinali --- φάρμακο --- medicinski proizvod --- medicinal product --- gyógyászati készítmény --- Advertising --- Consumer protection --- Comparative law --- Consommateurs --- Droit comparé --- Drugs --- Law and legislation --- Medical instruments and apparatus --- Appareils et instruments --- Protection --- dlí leighis --- íoc leighis --- Belgique --- Médicaments --- Médicament --- Médecine --- Matériel médical --- Publicité --- Appareil et matériel. --- Droit médical --- Läkemedelsprodukter

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Right to health --- Drugs --- Patent medicines --- Public health laws --- Intellectual property. --- Droit à la santé --- Médicaments --- Spécialités pharmaceutiques --- Santé publique --- Propriété intellectuelle --- Patents --- Law and legislation. --- Brevets d'invention --- Droit --- Pharmaceutical Preparations --- Economics --- Human Rights --- Foreign trade regulation --- legislation and jurisprudence --- Health aspects --- Agreement on Trade-Related Aspects of Intellectual Property Rights --- Médicament --- Commerce international --- Geneesmiddel --- Recht op gezondheid --- Internationale handel --- Droit à la santé --- Médicaments --- Spécialités pharmaceutiques --- Santé publique --- Propriété intellectuelle --- Export and import controls --- Foreign trade control --- Import and export controls --- International trade --- International trade control --- International trade regulation --- Prohibited exports and imports --- Trade regulation --- Law and legislation --- Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce --- ADPIC --- Agreement Establishing the World Trade Organization --- Agreement on Trade-Related Intellectual Property Rights --- Agreement on TRIPs --- Guan mao zong xie ding yu mao yi you guan de zhi shi can quan xie ding (1994 April 15) --- Ittifāqīyat al-Jawānib al-Muttaṣilah bi-al-Tijārah min Ḥuqūq al-Milkīyah al-Fikrīyah (1994 April 15) --- Soglashenie po torgovym aspektam prav intellektualʹnoĭ sobstvennosti --- TRIPs --- TRIPs Agreement --- Uruguay Round Agreement on Trade-Related Intellectual Property Rights --- World Trade Organization-TRIPs Agreement --- WTO Agreement on Trade Related Intellectual Property Rights --- WTO-TRIPs Agreement --- international handel --- handel międzynarodowy --- tarptautinė prekyba --- starptautiskā tirdzniecība --- internationale handel --- comércio internacional --- меѓународна трговија --- međunarodna trgovina --- међународна трговина --- mednarodna trgovina --- internationaler Handel --- comerț internațional --- международна търговия --- mezinárodní obchod --- nemzetközi kereskedelem --- international trade --- kansainvälinen kauppa --- rahvusvaheline kaubandus --- commercio internazionale --- kummerċ internazzjonali --- tregti ndërkombëtare --- internationell handel --- διεθνές εμπόριο --- comercio internacional --- medzinárodný obchod --- sistema commerciale internazionale --- Camera di commercio internazionale --- διεθνείς εμπορικές συναλλαγές --- comércio mundial --- Welthandel --- comerț mondial --- tregti botërore --- maailmankauppa --- world trade --- comercio mundial --- παγκόσμιες εμπορικές συναλλαγές --- commerce mondial --- världshandel --- světový obchod --- commercio mondiale --- scambio internazionale --- verdenshandel --- maailmakaubandus --- svetový obchod --- pasaules tirdzniecība --- παγκόσμιο εμπόριο --- világkereskedelem --- wereldhandel --- pasaulinė prekyba --- svjetska trgovina --- õigus tervisele --- δικαίωμα στην υγεία --- tiesības uz veselību --- teisė į sveikatos priežiūrą --- right to health --- právo na zdravie --- egészséghez való jog --- право на здравље --- diritto alla salute --- dreptul la sănătate --- e drejtë për të gëzuar shëndet --- ret til sundhed --- rätt till hälsa --- derecho a la salud --- právo na zdraví --- direito à saúde --- pravica do zdravja --- recht op gezondheid --- dritt għas-saħħa --- oikeus terveyteen --- Recht auf Gesundheit --- pravo na zdravlje --- prawo do ochrony zdrowia --- право на здравје --- право на здраве --- πρόσβαση στην περίθαλψη --- accès aux soins --- acesso aos cuidados de saúde --- acceso a la asistencia sanitaria --- pravo na zdravstvenu skrb --- право на лекување --- accesso alle cure --- egészségügyi ellátáshoz való jog --- aprūpes tiesības --- právo na ochranu zdraví --- toegang tot gezondheidszorg --- pravo na liječenje --- пристап до здравствена заштита --- e drejta për kujdes --- dreptul la îngrijire --- right to care --- право на здравствена заштита --- õigus tervishoiule --- právo na léčení --- adgang til sundhedspleje --- hoitoonpääsy --- svobodný přístup k ochraně zdraví --- tillgång till hälso- och sjukvård --- Zugang zur Behandlung --- ravim --- lék --- lääke --- lijek --- mediċinament --- φάρμακα --- medicamento --- läkemedel --- лек --- medicament --- лекарство --- lek --- liek --- medicinale --- geneesmiddel --- medicamente --- Medikament --- gyógyszer --- medikament --- zdravilo --- vaistinis preparatas --- medikaments --- kapky --- orvosság --- medicamento per la medicina animale --- medicamento per la medicina umana --- zásyp --- medication --- mast --- tabletka --- vaistas --- Arznei --- tinktura --- mjekim --- lääkintä --- léčivý přípravek --- медикамент --- prášky --- prášek --- liečivý prípravok --- lääkitys --- îngrijire medicală --- dražé --- Arzneispezialität --- tableta --- čípek --- Arzneimittel --- лекарствен продукт --- medicin --- medikamentas --- zāles --- prodotti mediċinali --- produkt leczniczy --- lægemiddel --- remédio --- médicament --- lääkevalmiste --- prodotto medicinale --- medicijn --- trádáil idirnáisiúnta --- prodott mediċinali --- φάρμακο --- medicinski proizvod --- medicinal product --- gyógyászati készítmény --- ceart chun sláinte --- íoc leighis --- Pharmaceutical Preparations - legislation and jurisprudence --- Drugs - Patents --- Foreign trade regulation - Health aspects --- Médicament --- Läkemedelsprodukter