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.

本数据集囊括了在一年期间内提交给兽医药品管理局的所有不良事件报告。每一份不良事件报告均以“ADR编号”作为主键进行标识。个体产品并非通过产品名称进行识别，而是依据治疗类别进行区分。数据集涵盖了动物不良事件（包括疑似疗效不足的情况）、人类不良事件、关于休药期问题或动物产品中残留物存在的报告，以及提交给VMD的环境报告。任何人均可向VMD报告不良事件，但营销授权持有人依法必须在15天内向VMD报告所有严重的不良事件（导致死亡或显著、持久或永久性症状的事件）。欲了解更多信息，请参阅我们的宣传册：https://www.gov.uk/government/publications/reporting-side-effects-to-animal-medicines-pharmacovigilance。与不良事件相关的临床体征采用VeDDRA术语进行分类：SOC = 系统器官类别，HLT = 高级术语，PT = 偏好术语，LLT = 低级术语。关于VeDDRA的更多信息，请参阅：http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000173.jsp&mid=WC0b01ac058002dea6#section3。所有涉及兽医药品的不良事件均应报告给相关产品的药品管理局授权持有人或VMD。这可以通过在线方式完成，请访问：https://www.gov.uk/report-veterinary-medicine-problem。