GVP Module VI, which deals with the collection, management and submission of reports of suspected adverse reactions to medicinal products has been
amended. Revision 2  comes into effect on the 22 November 2017. Revision 2 boasts 144 pages versus the 90 pages of Revision 1 and a new 19 page addendum that focuses on duplicate management of suspected adverse reaction reports
Note for those who manage safety reports for non-interventional post-authorisation studies, Table VI.1 provides more detailed guidance for adverse events not collected, as specified in the study protocol.
Revision 2 contains the following:
  • Updated guidance on ICSRs submission, follow-up, duplicate detection and data quality management, taking into account the implementation of the new EudraVigilance system, and of the simplified submission of ICSRs in the EU in line with the provisions provided in Article 24 of Regulation (EC) No 726/2004 and Article 107 and 107a of Directive 2001/83/EC
  • Updated guidance on the validation of ICSRs based on patients and reporters identifiability
  • Updated guidance on the management of ICSRs described in the medical literature
  • Updated guidance on the collection of information on patient’s age
  • Updated guidance on the management of suspected adverse reactions reported through medical enquiry and product information services
  • New guidance on the electronic submission modalities of ICSRs under the new ICH E2B(R3) format
  • New guidance on the management of individual reports of off-label use, based on the Reflection Paper on Collecting and Reporting Informati on on Off-label Use in Pharmacovigilance (EMA/293194/2016), published for public consultation in 2016;
  • New guidance on the management of reports from post-authorisation efficacy studies
  • Transfer of the guidance on emerging safety issue to GVP Module IX
  • Editorial amendments to align the format with other GVP Modules