GVP Module VIII – Revision 2 Published

Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies (Rev 2)

Revision 2 contains the following:

• Changes to VIII.A., clarifying the link between the legislation on non-interventional PASS and categories 1-3 of non-interventional PASS described in GVP Module V;
• Changes to VIII.B., amending and re-organising the text of several sections to provide a better distinction between legal obligations and recommendations to marketing authorisation holders;
• Changes to VIII.B.3.1, adding text in line with GVP Module VI Rev 1 to provide a recommendation on adverse events that will not be collected or reported;
• Changes to VIII.B.3. and VIII.B.4 with the sentences referring to the notification of study information to the Agency (substantial amendments to PASS protocols, progress reports and final reports) moved to GVP Module VIII Addendum I Rev 2;
• Change to VIII.B.4.3.2. (Format of study report) to add a section “Conclusion”;
• Changes to VIII.B.8. (Impact on the risk management system) to only refer to GVP Module V;
• Changes to previous VIII.C.1.d./now VIII.C.1.4., revising the text on joint studies to emphasise the role of the Agency and national competent authority to systematically encourage submission of joint protocols;
• Updating of the structure to bring the Module in line with other GVP Modules as structuring has consolidated over time (previous B.1. and C.1. on scope moved to A and previous B.2. moved to A.1);Editorial amendments throughout the Module;
• Revision of nearly all sections of VIII. Appendix 1 in order to:
  • provide updated and more detailed information on some study designs;
  • revise the terminology where needed
    • Change of the title;
    • Deletion of Tables XIII Add I.1. and XIII Add I.2. and simplification of presentation of submission requirements and recommendations based on legislation related to non-interventional post- authorisation safety studies;
    • Update of submission requirements for study protocols and progress reports according to Art 107m(5) based on updated information provided by Member States;
    • Addition of information regarding study registration in the EU PAS Register