Transcription of Guideline on good pharmacovigilance practices …
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Guideline on good pharmacovigilance practices …
28 March 2017. EMA/816573/2011 Rev 2*. Guideline on good pharmacovigilance practices (GVP). Module II pharmacovigilance system master file (Rev 2). Date for coming into effect of first version 2 July 2012. Date for coming into effect of Revision 1 12 April 2013. Draft Revision 2* finalised by the Agency in collaboration with Member 9 March 2017. States Draft Revision 2 agreed by the EU Network pharmacovigilance Oversight 23 March 2017. Group (EU-POG). Draft Revision 2 adopted by Executive Director as final 28 March 2017. Date for coming into effect of Revision 2 31 March 2017. *Note: Revision 2 contains the following: - deletion of text in referring to transition period as this is not applicable anymore.
Guideline on good pharmacovigilance practices (GVP) – Module II (Rev 2) EMA/816573/2011 Rev 2 Page 6/20 For other herbal medicinal products, not falling within the scope of the traditional-use registration, the
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