Directive 2001 83 EC

Results: 312



#Item
61Pharmaceutical sciences / Health / European Medicines Agency / Directive 2001/83/EC / Agenda / EudraLex / Clinical research / Pharmaceuticals policy / Research

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products – authorisations, European Medicines Agency Brussels,

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Source URL: ec.europa.eu

Language: English - Date: 2014-09-15 10:02:27
62Research / Health / European Medicines Agency / European Directive on Traditional Herbal Medicinal Products / Directive 2001/83/EC / Pharmacovigilance / Qualified Person / Qualified Person Responsible For Pharmacovigilance / Supplementary protection certificate / Pharmaceuticals policy / Clinical research / Pharmaceutical sciences

Administrative regulation[removed]Dnro[removed][removed]UNOFFICIAL TRANSLATION

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Source URL: www.fimea.fi

Language: English
63Health policy / Health / Directive 2001/83/EC / Directive 75/318/EEC / Directive 75/319/EEC / Directive 65/65/EEC / Directive 93/41/EEC / Supplementary protection certificate / Pharmaceuticals policy / Clinical research / Research

Risk regulation at international, European and national level MARKETING OF MEDICINAL PRODUCTS IN EUROPE: THE ABRIDGED PROCEDURE FOR MARKETING AUTHORISATION AUTHOR: Janske van Santvoort

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Source URL: www.riskregulation.org

Language: English - Date: 2008-01-17 11:13:05
64Patent law of the European Union / Supplementary protection certificate / Research / Health / Test data exclusivity / Directive 2001/83/EC / European Medicines Agency / Pharmaceuticals policy / Clinical research / Intellectual property law

RECOMMENDATIONS ON PAEDIATRIC USE MARKETING AUTHORISATIONS Doc. Ref.: CMDh[removed]Rev1 February 2012 BACKGROUND Paediatric Use Marketing Authorisations (PUMAs)

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Source URL: www.hma.eu

Language: English - Date: 2012-02-23 08:57:38
65Food safety / Good manufacturing practice / Quality assurance / Law / Health / Pharmaceutical sciences / Convention on Psychotropic Substances / COSHH / Evaluation / Pharmaceutical industry / Pharmaceuticals policy

COMMISSION DELEGATED REGULATION (EU) No 1252/•[removed]of 28 May[removed]supplementing Directive 2001/•83/•EC of the European Parliament and of the Council with regard to principles and gui

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Source URL: ec.europa.eu

Language: English - Date: 2014-12-05 07:31:46
66

RÈGLEMENT DÉLÉGUÉ (UE) No[removed]DE LA COMMISSION - du 28 mai[removed]complétant la directive 2001/•83/•CE du Parlement européen et du Conseil en ce qui concerne les principes et

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Source URL: ec.europa.eu

Language: French - Date: 2014-12-05 07:31:51
    67Research / European Union / Biologic / Medicinal product / Directive 2001/83/EC / Health / Supplementary protection certificate / Pharmacology / Pharmaceuticals policy / Clinical research

    CMDh QUESTIONS & ANSWERS BIOLOGICALS Doc. Ref.: CMDh[removed], Rev.0 October 2012 What is the definition of a biological medicinal product? .................................................................. 2 How is this

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    Source URL: www.hma.eu

    Language: English - Date: 2014-11-05 12:22:48
    68Pharmaceutical sciences / Health / EudraLex / Summary of Product Characteristics / European Directive on Traditional Herbal Medicinal Products / Medicinal product / Directive 2001/83/EC / Validation / Bioequivalence / Pharmaceuticals policy / Clinical research / Research

    CMD(h)CMDh BEST PRACTICE GUIDE ON THE COMPILATION OF THE DOSSIER FOR NEW APPLICATIONS SUBMITTED IN MUTUAL RECOGNITION & DECENTRALISED PROCEDURES Doc. Ref.: CMDh[removed]Rev.1

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    Source URL: www.hma.eu

    Language: English - Date: 2014-10-10 05:13:04
    69Patent law of the European Union / Supplementary protection certificate / Research / Health / Test data exclusivity / Directive 2001/83/EC / European Medicines Agency / Pharmaceuticals policy / Clinical research / Intellectual property law

    RECOMMENDATIONS ON PAEDIATRIC USE MARKETING AUTHORISATIONS Doc. Ref.: CMDh[removed]Rev1 July 2009 February 2012 BACKGROUND

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    Source URL: www.hma.eu

    Language: English - Date: 2012-02-23 09:03:34
    70Research / European Union / Law / EudraLex / Directive 2001/83/EC / Clinical Trials Directive / European Medicines Agency / Clinical research / Pharmaceuticals policy / European Union directives

    ADVISORY Advice on the implementation of EU-Directive[removed]EU

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    Source URL: www.egagenerics.com

    Language: English - Date: 2014-12-27 09:47:51
    UPDATE