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Items tagged with EU Files

192632/2006 EU RMP template

Updated on 22 December 2011

  • Risk Management Plan template for EU
  • Version: 27 September 2006
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2001/20/EC Directive

Updated on 18 December 2011

  • Clinical Trials Directive
  • Version: 4 April 2001
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2001/83/EC Directive

Updated on 29 December 2011

  • Post marketing "pharmacovigilance" directive
  • Version: 6 November 2001
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2005/28/EC Directive

Updated on 18 December 2011

  • The GCP directive
  • Version: 8 April 2005
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2010/84/EU Directive

Updated on 18 December 2011

  • 2010 Pharmacovigilance directive amendment of directive 2001/83/EC
  • Version: 15 December 2010
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65/65/EEC Directive

Updated on 18 December 2011

  • The original EU directive for control with Pharmaceutical Medicines
  • Version: 26 January 1965
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75/318/EEC Directive

Updated on 18 December 2011

  • The first EU directive for control with Clinical Trials
  • Version: 20 May 1975
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75/319/EEC Directive

Updated on 18 December 2011

  • The second directive regarding approval of Pharmaceutical Products in the EU
  • Version: 20 May 1975
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95/46/EC Directive

Updated on 18 December 2011

  • Data Privacy directive which is the basis for individual memberstates data protection legislation
  • Version: 24 October 1995
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EU PV legislation impact analysis Executive Summary

Updated on 30 April 2012

  • Analysis of implementation cost for 2012 EU PV legislation
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EU PV legislation impact analysis vol 1

Updated on 30 April 2012

  • Analysis of implementation cost for 2012 EU PV legislation
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EU PV legislation impact analysis vol 2

Updated on 30 April 2012

  • Analysis of implementation cost for 2012 EU PV legislation
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Guidance CT3

Updated on 18 December 2011

  • Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)
  • Version: 11 June 2011
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Regulation 1235/2010

Updated on 01 May 2012

  • Regulation of authorisation and supervision of medicinal products for human and veterinary use
  • Version: 15 December 2010
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Volume 9A v 2008

Updated on 29 December 2011

  • Guidelines on Pharmacovigilance for Medicinal Products for Human Use
  • Version: 2008
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