This Module of GVP addresses the legal requirements detailed in Directive 2001/83/EC [DIR] and Regulation (EC) No 726/2004 [REG], which are applicable to competent authorities in Member States, marketing authorisation holders and the Agency as regards the collection, data management and submission of individual reports of suspected adverse reactions (serious and non-serious) associated with medicinal products for human use authorised in the European Union (EU).

Section VI.B. of this Module highlights the general principles, based on the pharmacovigilance guidelines E2A, E2B and E2D of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) (see GVP Annex IV), in relation to the collection, recording and submission of individual reports of suspected adverse reactions associated with medicinal products for human use. The definitions and guidance provided in Section VI.A. and the EU specific requirements presented in Section VI.C. should be followed.

All applicable legal requirements are referenced in the way explained in the GVP Introductory Cover Note and are usually identifiable by the modal verb “shall”. Guidance for the implementation of legal requirements is provided using the modal verb “should”.

The guidance provided in this Module does not address the collection, management and submission of individual reports of events or patterns of use, which do not result in suspected adverse reactions (e.g. asymptomatic overdose, abuse, misuse or medication error) and which are not required to be submitted as individual case safety reports (ICSRs). This information may however need to be collected and presented in periodic safety update reports for the interpretation of safety data or for the benefit risk evaluation of medicinal products. With regard to this, the guidance provided in GVP Module VII applies.