Revision 2 of EMA GVP Module VIII has been released for public consultation
Revision 2 contains the following:

  • Changes to VIII.A., clarifying the link between the legislation on non-interventional PASS and categories 1-4 of non-interventional PASS described in GVP Module V;
  • 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 XIII.B.4. with the sentence referring to the notification of substantial amendments to PASS protocols, progress reports and final reports to the Agency for centrally- authorised products moved to GVP XIII Addendum I Rev 2;
  • Changes to VIII.B.8. with additions from previous VIII.C.3., removing duplication of text;
  • Changes to VIII.C.2.d., specifying that the definition of the core elements of a PASS protocol will normally be a first step in the process leading to joint studies, prior to the agreement (or not) of a joint study by different marketing authorisation holders;
  • 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
  • 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.
Refer to : Guideline on good pharmacovigilance practices (GVP) – Module VIII Addendum I – Requirements for transmission of information on non-interventional post-authorisation safety studies (Rev. 2)
The public consultation is restricted to the yellow highlighted revised texts (i.e. replaced by new texts with deletions and additions) or deleted texts (i.e. not replaced)

. The deadline for comments is 9 October 2015.  Comments should be provided using this template. The completed comments form should be sent to

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