Gaois

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19 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research

    #681376

    IATE #2146586
    táirge íocshláinte imscrúdaitheach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Prüfpräparat
    de
    Definition pharmazeutische Form eines Wirkstoffs oder Placebos, die in einer klinischen Prüfung getestet oder als Referenzsubstanz verwendet wird Reference "Richtlinie 2001/20/EG des Europäischen Parlaments und des Rates vom 4. April 2001 zur Angleichung der Rechts- und Verwaltungsvorschriften der Mitgliedstaaten über die Anwendung der guten klinischen Praxis bei der Durchführung von klinischen Prüfungen mit Humanarzneimitteln CELEX:32001L0020/DE"
    investigational medicinal product | IMP | investigational product | investigational medicine | medicinal product for trial
    en
    Definition "medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial" Reference "Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC"
    Comment Does not include medicinal products used for background treatment, challenge agents, rescue medication, or medicinal products used to assess end-points in a clinical trial.
    médicament expérimental
    fr
    Definition médicament expérimenté ou utilisé comme référence, y compris en tant que placebo, lors d'un essai clinique Reference "Règlement (UE) n o 536/2014 relatif aux essais cliniques de médicaments à usage humain et abrogeant la directive 2001/20/CE"
  3. EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency

    #681319

    IATE #2100646
    an Coiste um Tháirgí Íocshláinte Luibhe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Déanfar saineolas an Choiste um Ardteiripí (CAT), an Choiste um Tháirgí Íocshláinte Dílleachta (COMP), an Choiste Phéidiatraicigh (PDCO) agus an Choiste um Tháirgí Íocshláinte Luibhe (HMPC) a choinneáil agus a atheagrú i bhfoirm meithleacha agus díorma saineolaithe a thabharfaidh ionchur do CHMP ...' Reference "Togra le haghaidh Rialachán lena leagtar síos nósanna imeachta Aontais maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus lena mbunaítear rialacha lena rialaítear an Ghníomhaireacht Leigheasra Eorpach, lena leasaítear Rialachán (CE) Uimh. 1394/2007 agus Rialachán (AE) Uimh. 536/2014 agus lena n-aisghairtear Rialachán (CE) Uimh. 726/2004, Rialachán (CE) Uimh. 141/2000 agus Rialachán (CE) Uimh. 1901/2006, CELEX:52023PC0193/GA"
    Committee on Herbal Medicinal Products | Committee for Herbal Medicinal Products | HMPC | Herbal Committee
    en
    Definition committee, established in 2004, composed of scientific experts from the EU Member States in the field of herbal medicinal products, to assist in the harmonisation of procedures and provisions concerning herbal medicinal products in EU Member States, and further integrate herbal medicinal products in the European regulatory framework Reference "COM-EN, based on: Directive 2004/24/EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use"
  4. SOCIAL QUESTIONS|health|pharmaceutical industry · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|committee (EU)

    #609066

    IATE #843393
    an Coiste um Tháirgí Íocshláinte lena nÚsáid ag an Duine Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Ausschuss für Humanarzneimittel
    de
    Definition Teil der Agentur, zuständig für die Formulierung des Gutachtens der Agentur zu allen Fragen bezüglich der Zulässigkeit der nach dem zentralisierten Verfahren eingereichten Dossiers, der Erteilung, Änderung, Aussetzung oder des Widerrufs einer Genehmigung für das Inverkehrbringen eines Humanarzneimittels [...] sowie bezüglich der Pharmakovigilanz Reference "VO 726/2004 Gemeinschaftsverfahren für die Genehmigung und Überwachung von Human- und Tierarzneimitteln und zur Errichtung einer Europäischen Arzneimittel-Agentur, Art.5 (ABl. L_136/2004, S.1) CELEX:32004R0726/DE"
    Comment DIV: RSZ 03/12/2002;UPDATED: AIH 28/05/2004; UPD: CHO 26/06/07
    Committee for Medicinal Products for Human Use | CHMP | Committee for Proprietary Medicinal Products | CPMP | Committee on Medicinal Products for Human Use
    en
    Definition Committee attached to the European Medicines Agency and responsible for drawing up the Agency's opinions on, inter alia, the granting, variation, suspension or revocation of an authorisation to place a medicinal product for human use on the market, and pharmacovigilance. Reference "Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency"
    comité des médicaments à usage humain | CHMP | CPMP | Comité des spécialités pharmaceutiques
    fr
    Definition "Comité relevant de l'Agence européenne des médicaments [IATE:843722 ], chargé de formuler l'avis de l'Agence sur, entre autres, la recevabilité, l'octroi, la modification, la suspension ou le retrait d'une autorisation de mise sur le marché d'un médicament à usage humain, ainsi que de la pharmacovigilance." Reference "CELEX:32004R0726/FR"
    CHMP
    mul
  5. EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency

    #676306

    IATE #916386
    an Coiste um Tháirgí Íocshláinte Dílleachtacha Reference Téarmeolaithe COM-GA
    ga
    an Coiste um Tháirgí Íocshláinte Dílleachta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Ausschuß für Arzneimittel für seltene Leiden
    de
    Comment DIV: RSZ 12/03/2003
    Committee for Orphan Medicinal Products | COMP
    en
    Definition Committee set up by Article 4 of Regulation (EC) No 141/2000 on orphan medicinal products; its tasks include examining applications for the designation of a medicinal product as an orphan medicinal product and advising the Commission on the establishment and development of a policy on orphan medicinal products for the European Union Reference "Based on Article 4, Regulation (EC) No 141/2000 on orphan medicinal products, CELEX:32000R0141"
    Comité des médicaments orphelins
    fr
    Comment institué en vertu de l’article 4 du règlement (CE) n o 141/2000
    COMP
    mul
  6. EUROPEAN UNION · SOCIAL QUESTIONS|health|pharmaceutical industry · AGRICULTURE, FORESTRY AND FISHERIES|agricultural activity|animal health

    #675426

    IATE #844119
    an Coiste um Tháirgí Íocshláinte Tréidliachta Reference "Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle an 11 Nollaig 2018 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE"
    ga
    an Coiste um Tháirgí Íocshláinte d'Úsáid Tréidliachta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Ausschuss für Tierarzneimittel | CVMP
    de
    Definition einer der wissenschaftlichen Ausschüsse der Europäischen Arzneimittel-Agentur, zuständig für die Gutachten zu allen Fragen der Zulässigkeit der nach dem zentralisierten Verfahren eingereichten Dossiers sowie der Erteilung, Änderung, Aussetzung oder des Widerrufs einer Genehmigung für das Inverkehrbringen eines Tierarzneimittels Reference "VO 726/2004 Gemeinschaftsverfahren für die Genehmigung, Überwachung und Pharmakovigilanz von Human- und Tierarzneimitteln und zur Errichtung einer Europäischen Arzneimittel-Agentur, Art.30 (ABl. L_136/2004) CELEX:32004R0726"
    Comment DIV: AIH 28/05/2004 UPD: ajs 20.9.2006
    Committee for Veterinary Medicinal Products | CVMP | Committee for Medicinal Products for Veterinary Use | Committee for Veterinary Medical Products | Committee for Medical Products for Veterinary Use
    en
    Definition "European Medicines Agency's committee responsible for veterinary medicines" Reference "European Medicines Agency > Committees > Committee for Veterinary Medicinal Products (CVMP) (3.7.2023)"
    Comment "Established by Article 139(1) of Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products and repealing Directive 2001/82/EC."
    comité des médicaments à usage vétérinaire | CVMP | CMV
    fr
    Definition comité chargé de formuler l'avis de l'Agence européenne des médicaments sur toute question concernant la recevabilité des dossiers présentés en suivant la procédure centralisée, l'octroi, la modification, la suspension ou le retrait d'une autorisation de mise sur le marché d'un médicament vétérinaire [...] ainsi que la pharmacovigilance Reference "Règlement (CE) n° 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, article 30, CELEX:32004R0726/fr"
    Comment "MISC: Relève de l'Agence européenne des médicaments (IATE:843722 )."
  7. SOCIAL QUESTIONS|health|health policy · SOCIAL QUESTIONS|health|pharmaceutical industry

    #682913

    IATE #3535603
    monagraf de luibheanna an Aontais Eorpaigh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Gemeinschaftliche Pflanzenmonografie
    de
    European Union herbal monograph | EU herbal monograph | Union herbal monograph | Community herbal monograph | Community herbal monograph for herbal medicinal products
    en
    Definition "monograph that contains the HMPC's scientific opinion on safety and efficacy data about a herbal substance and its preparations intended for medicinal use" Reference "COM-Terminology Coordination, based on: EMA. Human Regulatory. 'European Union monographs and list entries' (5.6.2023)"
    monographie communautaire de plantes médicinales
    fr
  8. EUROPEAN UNION|EU institutions and European civil service|EU office or agency · SOCIAL QUESTIONS|health|pharmaceutical industry

    #609098

    IATE #843722
    an Ghníomhaireacht Leigheasra Eorpach Reference Togra le haghaidh Rialacháin ón gComhairle lena leasaítear Rialachán (CE) Uimh. 297/95 maidir le táillí is iníoctha leis an nGníomhaireacht Leigheasra Eorpach mar aon le nóta faisnéise míniúcháin. COM (2005) 106.
    ga
    EMA Reference "https://europa.eu/european-union/about-eu/agencies/ema_ga"
    ga
    Context Déanann an Ghníomhaireacht Leigheasra Eorpach (EMA) sláinte an duine agus sláinte ainmhithe a chosaint agus a chur chun cinn trí mheastóireacht agus monatóireacht a dhéanamh ar leigheasanna laistigh den Aontas Eorpach (AE) agus den Limistéar Eorpach Eacnamaíoch (LEE). Reference "https://europa.eu/european-union/about-eu/agencies/ema_ga"
    gníomhaireacht measúnú táirge íochshláinte, GLE
    ga
    EMEA Reference "Interinstitutional Style Guide 9.5.3 (a) on unique abbreviations for all linguistic versions. http://publications.europa.eu/code/en/en-390500.htm09/09/2009 ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Europäische Arzneimittel-Agentur | Agentur Beurteilung Arzneimitteln | EMA | EMEA | Europäische Agentur für die Beurteilung von Arzneimitteln
    de
    Definition dezentrale Einrichtung der Europäischen Union für die Beurteilung und Überwachung von Human- und Tierarzneimitteln Reference "Europ. Kommission http://europa.eu/agencies/community_agencies/emea/index_de.htm"
    European Medicines Evaluation Agency | European Medicines Agency | European Agency for the Evaluation of Medicinal Products | EMA | EAMA | EMEA
    en
    Definition agency, established by Regulation (EEC) No 2309/93 of 22 July 1993 and renamed by Regulation (EC) No 726/2004, which is responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products Reference "COM-EN, based on:- Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, CELEX:31993R2309/EN - Regulation (EC) No 726/2004 of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, CELEX:32004R0726/EN"
    Agence européenne des médicaments | médicament pour l'évaluation | EMA | EMEA | AEM AEEM | Agence européenne pour l'évaluation des médicaments
    fr
    Definition agence de l'UE chargée de coordonner les ressources scientifiques existantes mises à sa disposition par les États membres en vue de l'évaluation, de la surveillance et de la pharmacovigilance des médicaments Reference "Règlement (CE) no 726/2004 du Parlement européen et du Conseil du 31 mars 2004 établissant des procédures de l'Union 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 (Texte présentant de l'intérêt pour l'EEE)Texte présentant de l'intérêt pour l'EEE"
  9. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688249

    IATE #3639984
    táirge íocshláinte go mbainfear úsáid atruach as Reference "Togra le haghaidh Rialachán lena leagtar síos nósanna imeachta Aontais maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus lena mbunaítear rialacha lena rialaítear an Ghníomhaireacht Leigheasra Eorpach, lena leasaítear Rialachán (CE) Uimh. 1394/2007 agus Rialachán (AE) Uimh. 536/2014 agus lena n-aisghairtear Rialachán (CE) Uimh. 726/2004, Rialachán (CE) Uimh. 141/2000 agus Rialachán (CE) Uimh. 1901/2006, CELEX:52023PC0193/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    medicinal product for compassionate use
    en
    Definition medicinal product belonging to the categories referred to in Article 3(1) and (2) of Regulation xxx available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who cannot be treated satisfactorily by an authorised medicinal product Reference "COM-Terminology Coordination, based on: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006, COM(2023) 193"
  10. SOCIAL QUESTIONS|health|health policy · SOCIAL QUESTIONS|health|pharmaceutical industry

    #647272

    IATE #3535658
    táirge íocshláinte lena úsáid ag an duine Reference "Rialachán (AE) Uimh. 1235/2010 lena leasaítear, maidir le cógas-aireachas ar tháirgí íocshláinte lena n-úsáid ag an duine, Rialachán (CE) Uimh. 726/2004 lena leagtar síos nósanna imeachta Comhphobail maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus le haghaidh úsáide tréidliachta agus lena mbunaítear Gníomhaireacht Leigheasra Eorpach, agus Rialachán (CE) Uimh. 1394/2007 maidir le táirgí íocshláinte ardteiripe, CELEX:32010R1235/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Context 'Déantar roinnt táirgí íocshláinte lena n-úsáid ag an duine a údarú, áfach, faoi réir an choinníll go ndéanfar faireachán breise orthu. Áirítear ina measc sin gach táirge íocshláinte lena úsáid ag an duine a bhfuil substaint ghníomhach nua ann agus táirgí íocshláinte bitheolaíochta lena n-áirítear bithshamhlacha ar tosaíochtaí iad don chógas-aireachas.' Reference "Rialachán (AE) Uimh. 1235/2010 lena leasaítear, maidir le cógas-aireachas ar tháirgí íocshláinte lena n-úsáid ag an duine, Rialachán (CE) Uimh. 726/2004 lena leagtar síos nósanna imeachta Comhphobail maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus le haghaidh úsáide tréidliachta agus lena mbunaítear Gníomhaireacht Leigheasra Eorpach, agus Rialachán (CE) Uimh. 1394/2007 maidir le táirgí íocshláinte ardteiripe, CELEX:32010R1235/GA"
    Humanarzneimittel
    de
    medicinal product for human use
    en
    Definition in the framework of Directive 2001/83/EC, any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis Reference "Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, CELEX:02001L0083-20121116/EN"
    Comment "See also:- IATE:773210 ""veterinary medicinal product; medicinal product for veterinary use"" - IATE:793544 ""medicinal product"""
    médicament à usage humain
    fr
  11. SOCIAL QUESTIONS|health|pharmaceutical industry

    #602461

    IATE #159306
    táirge íocshláinte péidiatraiceach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Kinderarzneimittel | Pharmazeutika für Kinder | pädiatrische Arzneimittel
    de
    paediatric medicinal product | paediatric medicine | paediatric drug | medicinal product for use in the paediatric population | medicinal product for children | pediatric medicinal product | pediatric medicine | pediatric drug | medicinal product for use in the pediatric population
    en
    Definition medicinal product used to treat persons aged 0-18 Reference "COM-Terminology Coordination, based on:Regulation (EC) No 1901/2006 on medicinal products for paediatric use"
    médicament pédiatrique | médicament à usage pédiatrique
    fr
    Definition médicament destiné aux enfants Reference "Organisation mondiale de la santé, Médicaments: médicaments destinés aux enfants, http://www.who.int/mediacentre/factsheets/fs341/fr/ [12.12.2013]"
  12. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688181

    IATE #3639827
    táirge íocshláinte ar oideas liachta ‘srianta’, a chuirtear in áirithe lena n‑úsáid i sainréimsí áirithe Reference "Togra le haghaidh Treoir maidir le Cód an Aontais a bhaineann le táirgí íocshláinte lena n‑úsáid ag an duine, agus lena n‑aisghairtear Treoir 2001/83/CE agus Treoir 2009/35/CE, CELEX:52023PC0192/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    medicinal product on ‘restricted’ medical prescription, reserved for use in certain specialised areas
    en
  13. SOCIAL QUESTIONS|health|pharmaceutical industry

    #675855

    IATE #885035
    táirge íocshláinte dílleachtach Reference Comhairle-GA
    ga
    Context """Ba cheart gur de réir oibleagáidí ar leith a dhéanfaí údaruithe margaíochta den sórt sin a dheonú. Ba cheart go mbeadh sna catagóirí táirgí íocshláinte lena n-úsáid ag an duine lena mbaineann na táirgí íocshláinte, lena n-áirítear táirgí íocshláinte dílleachtacha, a bhfuil sé mar aidhm leo galair thromchúiseacha dhíblitheacha nó is baol báis a chóireáil nó a chosc...""" Reference "Rialachán (AE) 2019/5 ó Pharlaimint na hEorpa agus ón gComhairle"
    druga dílleachta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    táirge íocshláinte dílleachta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    táirge íocshláinte dílleachtach lena úsáid ag an duine Reference Téarmeolaithe COM-GA
    ga
    Arzneimittel für seltene Leiden | Orphan-Arzneimittel | Humanarzneimittel für seltene Leiden
    de
    Definition ein nach den Bestimmungen der Verordnung (EG) Nr. 141/2000 ausgewiesenes Arzneimittel (Orphan medicinal product) Reference "Verordnung (EG) Nr. 141/2000, Artikel 2 Buchstabe b CELEX:32000R0141/DE"
    Comment "Gemäß der Verordnung (EG) Nr. 141/2000 sind dies nicht nur Arzneimittel für seltene Krankheiten (Kriterium: 5 Erkrankungen auf 10.000 Personen), sondern auch aus anderen Gründen nicht-rentable Arzneimittel (vgl. Artikel 3 Absatz 1 Buchstabe a).Die richtige Bezeichnung für ""Orphan disease""/""maladie orpheline"" im Deutschen lautet ""Waisenkrankheit"" oder ""Orphan-Krankheit"" (siehe IATE:139134 ). ""Seltene Krankheit"" steht dagegen für ""rare disease""/""maladie rare"" IATE:883096 ."
    orphan medicinal product | orphan medicine | orphan drug | orphan medicinal product for human use
    en
    Definition medicinal product intended for the diagnosis, prevention or treatment of a life-threatening or very serious condition, where no other such product exists because it would not be economically viable to develop one and/or because the condition is rare Reference "Council-EN based on Regulation (EC) No 141/2000 on orphan medicinal products, Article 3 CELEX:02000R0141-20190726"
    Comment "The regulatory designation as an 'orphan medicinal product' is associated with incentives intended to promote the development of such medicines.See also:- orphan disease, IATE:139134 - rare disease, IATE:883096<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><>"
    médicament orphelin | médicament orphelin à usage humain
    fr
    Definition médicament destiné à traiter une maladie grave et rare, à laquelle les investisseurs s'intéressent peu Reference "Délégation générale à la langue française et aux langues de France (DGLFLF), FranceTerme, http://www.culture.fr/franceterme/result?francetermeSearchTerme=medicament+orphelin&francetermeSearchDomaine=0&francetermeSearchSubmit=rechercher&action=search [22.10.2018]"
    Comment "Dans le cadre juridique de l'Union européenne, un médicament orphelin est un médicament ainsi désigné dans les conditions prévues par le règlement n° 141/2000 concernant les médicaments orphelins. Conformément audit règlement, un médicament obtient la désignation de médicament orphelin si son promoteur peut établir:a) qu'il est destiné au diagnostic, à la prévention ou au traitement d'une affection entraînant une menace pour la vie ou une invalidité chronique ne touchant pas plus de cinq personnes sur dix mille dans la Communauté, au moment où la demande est introduite, ouqu'il est destiné au diagnostic, à la prévention ou au traitement, dans la Communauté, d'une maladie mettant la vie en danger, d'une maladie très invalidante ou d'une affection grave et chronique, et qu'il est peu probable que, en l'absence de mesures d'incitation, la commercialisation de ce médicament dans la Communauté génère des bénéfices suffisants pour justifier l'investissement nécessaireetb) qu'il n'existe pas de méthode satisfaisante de diagnostic, de prévention ou de traitement de cette affection ayant été autorisée dans la Communauté, ou, s'il en existe, que le médicament en question procurera un bénéfice notable à ceux atteints de cette affection.Conseil-FR, d'après le règlement n° 141/2000 concernant les médicaments orphelins, CELEX:02000R0141-20090807/FR Voir aussi:- maladie orpheline [IATE:139134 ]- maladie rare [IATE:883096 ]"
  14. EUROPEAN UNION|European Union law|EU act · SOCIAL QUESTIONS|health|pharmaceutical industry · AGRICULTURE, FORESTRY AND FISHERIES|means of agricultural production|means of agricultural production · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|intellectual property

    #656884

    IATE #3570854
    an Rialachán maidir le deimhnithe forlíontacha cosanta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Rialachán (CE) Uimh. 469/2009 maidir leis an deimhniú forlíontach cosanta le haghaidh táirgí íocshláinte Reference "Rialachán (CE) Uimh. 469/2009 maidir leis an deimhniú forlíontach cosanta le haghaidh táirgí íocshláinte, CELEX:32009R0469/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Verordnung (EG) Nr. 469/2009 über das ergänzende Schutzzertifikat für Arzneimittel | ESZ-Verordnung
    de
    SPC Regulation | EU SPC Regulation | Regulation on Supplementary Protection Certificates | Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products
    en
    Comment Entry into force: 6.7.2009
    règlement CCP | règlement relatif au certificat complémentaire de protection | règlement (CE) n° 469/2009 concernant le certificat complémentaire de protection pour les médicaments
    fr
  15. SOCIAL QUESTIONS|health|pharmaceutical industry

    #685112

    IATE #3580235
    Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine Reference "Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, CELEX:2014R0536-20140527/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Clinical Trial Regulation | Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use
    en
    Definition Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use Reference "Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance) "
  16. EUROPEAN UNION|EU institutions and European civil service|EU institution|European Commission · SOCIAL QUESTIONS|health|pharmaceutical industry · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|committee (EU)|standing committee (EU)

    #615501

    IATE #926394
    an Buanchoiste um Tháirgí Íocshláinte lena nÚsáid ag an Duine Reference "Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine"
    ga
    Context 'Beidh an Buanchoiste um Tháirgí Íocshláinte lena nÚsáid ag an Duine, arna bhunú le Treoir 2001/83/CE, de chúnamh don Choimisiún.' Reference "Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine"
    Ständiger Ausschuss für Humanarzneimittel
    de
    Standing Committee on Medicinal Products for Human Use | Committee for Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers in the Proprietary Medicinal Products Sector
    en
    Comment UPDATED: neq: 19/3/02
    comité permanent des médicaments à usage humain
    fr
  17. EUROPEAN UNION · AGRICULTURE, FORESTRY AND FISHERIES|agricultural activity|animal health

    #681306

    IATE #1917120
    Buanchoiste um Tháirgí Íocshláinte Tréidliachta Reference "Rialachán (CE) Uimh. 470/2009 lena leagtar síos nósanna imeachta Comhphobail chun teorainneacha na n-iarmhar a bhunú do shubstaintí atá gníomhach ó thaobh na cógaseolaíochta de i mbia-ábhair de thionscnamh ainmhíoch, agus lena n-aisghairtear Rialachán (CEE) Uimh. 2377/90 ón gComhairle agus lena leasaítear Treoir 2001/82/CE ó Pharlaimint na hEorpa agus ón gComhairle agus Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32009R0470/GA"
    ga
    Language usage Is gnách an t-alt a bheith roimh an ainm i.e. Buanchoiste um Tháirgí Íocshláinte Tréidliachta
    Ständiger Ausschuss für Tierarzneimittel
    de
    Standing Committee on Veterinary Medicinal Products | Standing Committee on Medicinal Products for Veterinary Use
    en
    comité permanent des médicaments vétérinaires
    fr
    Definition comité dont la fonction est d'assister la Commission en vue de l'adaptation au progrès technique des directives visant à l'élimination des entraves techniques aux échanges dans le secteur des médicaments vétérinaires Reference "COM-FR d'après Directive 2001/82/CE du Parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux médicaments vétérinaires, article 89, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32001L0082:FR:NOT"
  18. SOCIAL QUESTIONS|health|pharmaceutical industry · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|intellectual property · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research

    #675209

    IATE #799937
    deimhniú forlíontach cosanta le haghaidh táirgí íocshláinte Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context '... ciallaíonn ‘údarú margaíochta le haghaidh úsáid phéidiatraiceach’ údarú margaíochta a dheonaítear i leith táirge íocshláinte lena úsáid ag an duine nach gcosnaítear le deimhniú forlíontach cosanta faoi Rialachán (CE) Uimh. 469/2009 ó Pharlaimint na hEorpa agus ón gComhairle maidir leis an deimhniú forlíontach cosanta le haghaidh táirgí íocshláinte 65...' Reference "Togra le haghaidh Rialachán lena leagtar síos nósanna imeachta Aontais maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus lena mbunaítear rialacha lena rialaítear an Ghníomhaireacht Leigheasra Eorpach, lena leasaítear Rialachán (CE) Uimh. 1394/2007 agus Rialachán (AE) Uimh. 536/2014 agus lena n-aisghairtear Rialachán (CE) Uimh. 726/2004, Rialachán (CE) Uimh. 141/2000 agus Rialachán (CE) Uimh. 1901/2006, CELEX:52023PC0193/GA"
    ergänzendes Schutzzertifikat für Arzneimittel
    de
    supplementary protection certificate for medicinal products | SPC | SPCs | SPC for medicinal products
    en
    Definition certificate extending the duration of the intellectual property right in respect of a medicinal product covered by Regulation (EC) No 469/2009 Reference "Council-EN, based on definition on IATE:1268236 (""supplementary protection certificate"") and Regulation (EC) No 469/2009, CELEX:32009R0469/EN"
    Comment "The certificate is based on a patent covering the ""medicinal product"", which must have fallen within the scope of Regulation (EC) No 469/2009, CELEX:32009R0469/EN The duration of the intellectual property right may be extended by a maximum of 5 years (5.5 years in some cases). See also: supplementary protection certificate for plant protection products IATE:3533863<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><>"
    certificat complémentaire de protection pour les médicaments
    fr
    Definition titre de propriété industrielle créé par le règlement (CEE) nº1768/92 (tel que modifié depuis), qui permet de prolonger la protection d'un médicament soumis à autorisation de mise sur le marché et protégé par un brevet sur le territoire d'un État membre Reference Conseil-FR, d'après règlement (CE) nº469/2009 concernant le certificat complémentaire de protection pour les médicaments
    Comment "Il s'agit d'enrayer le recul de l'industrie pharmaceutique européenne sur le marché mondial face à la concurrence américaine et japonaise.Voir aussi:- IATE:1268236 certificat complémentaire de protection- IATE:3533863 certificat complémentaire de protection pour les produits phytopharmaceutiques."
  19. AGRICULTURE, FORESTRY AND FISHERIES|agricultural policy|agricultural policy|veterinary legislation · SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency

    #668024

    IATE #3629733
    táirge íocshláinte tréidliachta mar a bheartaítear le haghaidh margadh teoranta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Beidh feidhm ag muirear EUR 5 200 maidir le hiarraidh ar tháirge íocshláinte tréidliachta a aicmiú mar a bheartaítear le haghaidh margadh teoranta de réir bhrí Airteagal 4(29) de Rialachán (AE) 2019/6 agus chun é a mheas le haghaidh incháilitheachta le haghaidh údarú de bhun Airteagal 23 de Rialachán (AE) 2019/6.' Reference "Togra le haghaidh Rialachán maidir le táillí agus muirir is iníoctha leis an nGníomhaireacht Leigheasra Eorpach, lena leasaítear Rialachán (AE) 2017/745 ó Pharlaimint na hEorpa agus ón gComhairle agus lena n‑aisghairtear Rialachán (CE) Uimh. 297/95 ón gComhairle agus Rialachán (AE) 658/2014 ó Pharlaimint na hEorpa agus ón gComhairle,CELEX:52022PC0721/GA"
    product as intended for a limited market | veterinary medicinal product as intended for a limited market
    en
    Definition "veterinary product eligible for a 'limited market authorisation' under Articles 4(29) and 23 of Regulation (EU) 2019/6" Reference "COM-Terminology Coordination, based on: EMA. Veterinary Regulatory. 'Veterinary limited markets' (28.10.2022)"