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    EudraLex is the collection of rules and regulations governing medicinal products in the European Union. It consists of 10 volumes covering pharmaceutical legislation, guidelines for marketing authorization of human and veterinary medicines, good manufacturing practices, clinical trials, and pharmacovigilance. The directives establish requirements for pre-market approval of medicines and define rules for clinical trials and good clinical practices. EudraLex aims to harmonize regulation of medicines across the EU.

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    Eudralex: Jump To Navigationjump To Search

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    EudraLex is the collection of rules and regulations governing medicinal products in the European Union. It consists of 10 volumes covering pharmaceutical legislation, guidelines for marketing authorization of human and veterinary medicines, good manufacturing practices, clinical trials, and pharmacovigilance. The directives establish requirements for pre-market approval of medicines and define rules for clinical trials and good clinical practices. EudraLex aims to harmonize regulation of medicines across the EU.

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    EudraLex

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    EudraLex is the collection of rules and regulations governing medicinal products in the European Union. It consists of 10 volumes covering pharmaceutical legislation, guidelines for marketing authorization of human and veterinary medicines, good manufacturing practices, clinical trials, and pharmacovigilance. The directives establish requirements for pre-market approval of medicines and define rules for clinical trials and good clinical practices. EudraLex aims to harmonize regulation of medicines across the EU.

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    © All Rights Reserved
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    Download as docx, pdf, or txt
    120 views4 pages

    Eudralex: Jump To Navigationjump To Search

    Uploaded by

    Deen
    EudraLex is the collection of rules and regulations governing medicinal products in the European Union. It consists of 10 volumes covering pharmaceutical legislation, guidelines for marketing authorization of human and veterinary medicines, good manufacturing practices, clinical trials, and pharmacovigilance. The directives establish requirements for pre-market approval of medicines and define rules for clinical trials and good clinical practices. EudraLex aims to harmonize regulation of medicines across the EU.

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    EudraLex

    From Wikipedia, the free encyclopedia


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    European Union

    This article is part of a series on the


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    EudraLex is the collection of rules and regulations governing medicinal products in


    the European Union.

    Contents

     1Volumes
     2Directives
     3See also
     4References
     5External links

    Volumes[edit]
    EudraLex consists of 10 volumes:

     Concerning Medicinal Products for Human use:


    o Volume 1 - Pharmaceutical Legislation.
    o Volume 2 - Notice to Applicants.
     Volume 2A deals with procedures for marketing authorisation.
     Volume 2B deals with the presentation and content of the
    application dossier.
     Volume 2C deals with Guidelines.
    o Volume 3 - Guidelines.
     Concerning Medicinal Products for human use in clinical trials (investigational
    medicinal products).
    o Volume 10 - Clinical trials.
     Concerning Veterinary Medicinal Products:
    o Volume 5 - Pharmaceutical Legislation.
    o Volume 6 - Notice to Applicants.
    o Volume 7 - Guidelines.
    o Volume 8 - Maximum residue limits.
     Concerning Medicinal Products for Human and Veterinary use:
    o Volume 4 - Good Manufacturing Practices.
    o Volume 9 - Pharmacovigilance.
     Miscellaneous:
    o Guidelines on Good Distribution Practice of Medicinal Products for Human
    Use (94/C 63/03)

    Directives[edit]
     Directive 65/65/EEC1, requires prior approval for marketing of proprietary
    medicinal products
     Directive 75/318/EEC, clarifies requirements of 65/65/EEC1 and requires
    member states to enforce them
     Directive 75/319/EEC, requires marketing authorization requests to be drawn up
    only by qualified experts
     Directive 93/41/EEC, establishes the European Agency for the Evaluation of
    Medicinal Products
     Directive 2001/20/EC, defines rules for the conduct of clinical trials
     Directive 2001/83/EC
     Directive 2005/28/EC, defines Good Clinical Practice for design and conduct of
    clinical trials

    See also[edit]
     European Union law
     European Union directive
     European Commission
     Directorate-General
     EUR-Lex
     Regulation of therapeutic goods
     International Conference on Harmonisation of Technical Requirements for
    Registration of Pharmaceuticals for Human Use
     Good clinical practice
     European Medicines Agency
     EUDRANET
     EudraVigilance
     Title 21 of the Code of Federal Regulations (USA)
     Drug development

    References[edit]
     Eudralex,The Rules Governing Medicinal Products in the European Union,
    European Communities Commission. Directorate-General for Industry,
    Pharmaceuticals and Cosmetics.
    o Vol. 1: Pharmaceutical legislation: medicinal products for human
    use. ISBN 92-828-2032-7
    o Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-
    975780-X
    o Vol. 3: Guidelines: medicinal products for human use. ISBN 92-828-2436-
    5
    o Vol. 4: Good manufacturing practices: medicinal products for human and
    veterinary use. ISBN 92-828-2029-7
    o Vol. 5: Pharmaceutical legislation: veterinary medicinal products. ISBN 92-
    828-2037-8
    o Vol. 6: Notice to applicants: veterinary medical products. ISBN 0-11-
    985351-5
    o Vol. 7. Guidelines: Veterinary medicinal products. ISBN 0-11-985366-3
     Markus Hartmann and Florence Hartmann-Vareilles, The Clinical Trials Directive:
    How Is It Affecting Europe's Noncommercial Research?, PLoS Clin Trials. 2006
    June; 1(2): e13

    External links[edit]
     News on Pharmaceuticals, (European Union)
     EudraLex
     EUR-Lex
     Review of pharmaceutical legislation (EU DG Enterprise and Industry)
     Directorate General Enterprise and Industry (European Commission)

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