Management of adverse event reports
Some of the definitions in the guideline below do not apply in European Union / European Economic Area after the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) took effect on 28 January 2022.
Management of periodic summary update reports - Step 7
The guideline below does not apply in European Union / European Economic Area after the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) took effect on 28 January 2022.