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Items starting with # 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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1994/3144/UK Regulation

Updated on 18 December 2011

  • First post marketing regulation - later amended
  • Version: 1 January 1995
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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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2004/1031/UK Regulatrion

Updated on 18 December 2011

  • Statutory instrument 2004:1031 for the UK implementation of the EU clinical Trial directive
  • Version: 1 May 2004
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2005/28/EC Directive

Updated on 18 December 2011

  • The GCP directive
  • Version: 8 April 2005
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2006/1928/UK Regulation

Updated on 18 December 2011

  • UK regulatory implementation of the GCP directive 2005
  • Version: 29 August 2006
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2008/3097/UK Regulation

Updated on 18 December 2011

  • UK marketing regulation with requirements for MAHs
  • Version: 29 December 2008
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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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21CFR312

Updated on 31 December 2011

  • Regulation governing human drug research in the USA before marketing approval
  • Version: Current

21CFR314

Updated on 31 December 2011

  • Requirements for marketing approval in the US for a new drug
  • Version: Current

522 FDA device postmarket surveillance guidance

Updated on 12 January 2012

  • Device Safety Surveillance Guidance from FDA
  • Version: 27 April 2006
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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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