abcdefghijklmnopqrstuvwxyz#

Items tagged with PHARMACOVIGILANCE Files

192632/2006 EU RMP template

Updated on 22 December 2011

  • Risk Management Plan template for EU
  • Version: 27 September 2006
Download

1994/3144/UK Regulation

Updated on 18 December 2011

  • First post marketing regulation - later amended
  • Version: 1 January 1995
Download

2001/83/EC Directive

Updated on 29 December 2011

  • Post marketing "pharmacovigilance" directive
  • Version: 6 November 2001
Download

2008/3097/UK Regulation

Updated on 18 December 2011

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

2010/84/EU Directive

Updated on 18 December 2011

  • 2010 Pharmacovigilance directive amendment of directive 2001/83/EC
  • Version: 15 December 2010
Download

21CFR314

Updated on 31 December 2011

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

65/65/EEC Directive

Updated on 18 December 2011

  • The original EU directive for control with Pharmaceutical Medicines
  • Version: 26 January 1965
Download

75/319/EEC Directive

Updated on 18 December 2011

  • The second directive regarding approval of Pharmaceutical Products in the EU
  • Version: 20 May 1975
Download

Drug Law Germany

Updated on 02 January 2012

  • German drug law in English
  • Version: 28 September 2009, note newer updates may be available
Download

EU PV legislation impact analysis Executive Summary

Updated on 30 April 2012

  • Analysis of implementation cost for 2012 EU PV legislation
Download

EU PV legislation impact analysis vol 1

Updated on 30 April 2012

  • Analysis of implementation cost for 2012 EU PV legislation
Download

EU PV legislation impact analysis vol 2

Updated on 30 April 2012

  • Analysis of implementation cost for 2012 EU PV legislation
Download

FDA draft guidance on reponding to information requests

Updated on 29 December 2011

  • Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices
  • Version: December 2011 draft
Download

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
Download

RMP Draft Guide Australia

Updated on 29 December 2011

  • Draft guidance document for Australian RMPs Dec 2011
  • Version: 1.2
Download

Volume 9A v 2008

Updated on 29 December 2011

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

© 2011 Ottosen. All rights reserved.
All site content is provided "as is" and does not represent the views of any organization