All adverse reactions must be reported within 30 days via the new pharmacovigilance database. PSURs no longer have to be submitted; pharmacovigilance is carried out by means of signal detection.
An annual submission of the signal management statement or the validated signals according to the "Guideline on veterinary good pharmacovigilance practices (VGVP), Module: Signal Management" by the marketing authorisation holder is required.
Further inquiry note
Page last modified: 21/04/2022