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EudraLex




European Union

This article is part of the series:
Politics and government of
the European Union


Treaties
Rome · Maastricht (Pillars)
Amsterdam · Nice · Lisbon
Institutions
Commission

President José Manuel Barroso
Barroso Commission


Parliament

President Hans-Gert Pöttering
MEPs (2004-09 term)


Council

Presidency: Slovenia (Dimitrij Rupel)
High Representative · Voting


Other & Future Institutions

Court of Justice · Court of Auditors
Central Bank · European Council

Elections
Last election (2004) · 2007 by-election
Next election (2009) · Constituencies
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Related topics
States · Enlargement · Foreign relations
Law · EMU · Other bodies · Agencies

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

Additional recommended knowledge

Contents

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.
  • Miscellaneous:
    • Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)

Directives

See also

References


     
    This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "EudraLex". A list of authors is available in Wikipedia.
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