Suspected adverse event data submitted to the VMD

The dataset includes all adverse event reports submitted to the Veterinary Medicines Directorate during a one year period. Each adverse event report is identified by the primary key – “ADR No.”. Individual products are not identified by product name but by therapeutic group. The dataset includes animal adverse events (including suspected lack of expected efficacy), human adverse events, reports concerning withdrawal period issues or the presence of residues in animal products and environmental reports which were submitted to the VMD. Anyone can report an adverse event to the VMD, but marketing authorisation holders are legally required to report all serious adverse events (those resulting in death or significant, prolonged or permanent signs) to the VMD within 15 days. For further information please refer to our leaflet https://www.gov.uk/government/publications/reporting-side-effects-to-animal-medicines-pharmacovigilance. The clinical signs associated with adverse events are classified using VeDDRA terminology: SOC = system organ class HLT = higher level term PT = preferred term LLT = lower level term. Further information on VeDDRA can be found at http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000173.jsp&mid=WC0b01ac058002dea6#section3 All adverse events involving veterinary medicines should be reported to either the MAH of the product concerned or to the VMD. This can be done online at https://www.gov.uk/report-veterinary-medicine-problem.