Representatives of the marketing authorisation holder according to Regulation (EU) 2019/6 Article 14 Paragraph 1 a) are legally obliged to record and forward adverse event reports after the use of the veterinary medicinal products they distribute. This also applies to co-distributors if they are also representatives of the marketing authorisation holder. This obligation arises from Article 14 (1) (l) and Article 77 (3) of Regulation (EU) 2019/6.

The recording and forwarding of adverse event reports following the use of veterinary medicinal products distributed by co-distributors should be regulated in the agreement between the marketing authorisation holder and the co-distributor.
Co-distributors please refer to the information on contact details for reporting adverse events in the package leaflet (Hinweise zu den Vorlagen für Produkttexte für Tierarneimittel - DE only).

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