Transcription of Guideline on good pharmacovigilance practices (GVP)
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Guideline on good pharmacovigilance practices (GVP)
9 October 2017 2017. EMA/118465/2012 Rev 1*. Guideline on good pharmacovigilance practices (GVP). Module XV safety communication (Rev 1). Date for coming into effect of first version 24 January 2013. Draft Revision 1* finalised by the Agency in collaboration with Member States 17 November 2015. Draft Revision 1 agreed by the European Risk Management Facilitation Group 24 November 2015. (ERMS FG). Draft Revision 1 adopted by Executive Director 8 December 2015. Release for consultation 15 December 2015. End of consultation (deadline for comments) 29 February 2016.
communication e.g. on the resolution of a safety concern or updated recommendations. • The effectiveness of safety communication should be evaluated where appropriate and possible (see XV.B.7.). • Safety communications should comply with relevant requirements relating to individual data protection and confidentiality.
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