Transcription of Guideline on good pharmacovigilance practices (GVP)
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Guideline on good pharmacovigilance practices (GVP)
See websites for contact details European Medicines Agency Heads of Medicines Agencies The European Medicines Agency is an agency of the European Union European Medicines Agency and Heads of Medicines Agencies, 2012. Reproduction is authorised provided the source is acknowledged. 20 February 2012 1 EMA/873138/2011 2 Guideline on good pharmacovigilance practices (GVP) 3 Module VI management and reporting of adverse reactions to medicinal 4 products 5 Draft finalised by the agency in collaboration with Member States and submitted to ERMS FG 19 January 2012 Draft agreed by ERMS FG 24 January 2012 Draft adopted by Executive Director 20 February 2012 Start of public consultation 21 February 2012 End of consultation (deadline for comments) 18 April 2012 Anticipated date for coming into effect after finalisation July 2012 6 Comments should be provided using this template.
Module VI – Management and reporting of adverse reactions to medicinal . 5 . ... 102 VI.Appendix 1. Identification of biological medicinal products ..... 44 103 VI.Appendix 2. Detailed guidance on the monitoring of scientific and ... 119 VI.Appendix 6. Data quality monitoring of ICSRs transmitted electronically
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