EudraLex

European Union

This article is part of a series on the politics and government of the European Union

Executive Juncker Commission President Juncker (EPP) Vice Presidents College Civil Service Secretary-General Day

Legislative Parliament President Schulz (S&D) Largest groups; EPP (Manfred Weber) S&D (Gianni Pittella) 8th session (2014-19) 751 MEPs Bureau Vice Presidents Quaestor Conference Legislative procedure Council of the EU Luxembourgish Presidency Configurations General Foreign Justice and Home Economic Euro Legislative procedure Voting Secretariat Secretary-General Uwe Corsepius Directorates-general COREPER

Judiciary Court of Justice Members Rulings General Court Civil Service Tribunal

Central Bank President Draghi ESCB Euro EMU Eurozone

Court of Auditors Budget OLAF

Other bodies Agencies Investment Bank CoR EESC Ombudsman National parliaments

Policies and issues Foreign relations High Representative Federica Mogherini Ext. Action Service Foreign Policy Defence Policy Customs Union Enlargement Budget Four Freedoms Economic Area Area of FS&J Schengen Area Policies Agricultural Energy Fisheries Regional Citizenship Identity Pro-Europeanism Euroscepticism Integration Supranationalism Federalism United States of Europe Multi-speed Opt-outs Enhanced co-op Withdrawal

Elections 1979, 1984, 1989 1994, 1999, 2004, 2009 2014 (last election) Political parties Constituencies Referendums

Law Acquis Primacy Subsidiarity Treaties Fundamental Rights Membership

European Council President Tusk (EPP) Parties List of meetings

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

Volumes

EudraLex consists of 10 volumes:

• Concerning Medicinal Products for Human use:
  • Volume 1 - Pharmaceutical Legislation.
  • 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.
  • Volume 3 - Guidelines.
• Concerning Medicinal Products for human use in clinical trials (investigational medicinal products).
  • Volume 10 - Clinical trials.
• Concerning Veterinary Medicinal Products:
  • Volume 5 - Pharmaceutical Legislation.
  • Volume 6 - Notice to Applicants.
  • Volume 7 - Guidelines.
  • Volume 8 - Maximum residue limits.
• Concerning Medicinal Products for Human and Veterinary use:
  • Volume 4 - Good Manufacturing Practices.
  • Volume 9 - Pharmacovigilance.
• Miscellaneous:
  • Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)

Directives

• 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

• 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

• Eudralex,The Rules Governing Medicinal Products in the European Union, European Communities Commission. Directorate-General for Industry, Pharmaceuticals and Cosmetics.
  • Vol. 1: Pharmaceutical legislation: medicinal products for human use. ISBN 92-828-2032-7
  • Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-975780-X
  • Vol. 3: Guidelines: medicinal products for human use. ISBN 92-828-2436-5
  • Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use. ISBN 92-828-2029-7
  • Vol. 5: Pharmaceutical legislation: veterinary medicinal products. ISBN 92-828-2037-8
  • Vol. 6: Notice to applicants: veterinary medical products. ISBN 0-11-985351-5
  • 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

• News on Pharmaceuticals, (European Union)
• EudraLex
• EUR-Lex
• Review of pharmaceutical legislation (EU DG Enterprise and Industry)
• Directorate General Enterprise and Industry (European Commission)