Animal Health Committee
AHC reply: To the best of our knowledge the following applies for Adverse Events (AEs) reporting to the regulators in Europe:
1. Marketed products –AEs are reported via the normal PV system.
2. Pre-registered products – AEs reported according to the conditions of the trial permission. This can include GCP/GLP and non GCP studies. For GCP studies, reporting is also done according to GCP.
For non GCP studies, all AEs will be presented at least as part of the dossier. These AEs must have an assessment done according to the directive to establish whether the AEs are actually Adverse Reactions. For these AEs the dossier may be the first time that the regulator will be made aware of these AEs.
Other points for consideration:
3. For GCP studies where the comparator is registered. Any AE reporting for the comparator should be via the normal PV system and the IVP via GCP/trial permission.
4. Where the study is conducted in the EU however the comparator is not marketed in the EU but elsewhere, then the general advice would be to contact the global PV group to confirm where is was marketed and what are the reporting requirements for those countries.