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Quality control of immunological veterinary medicinal products in Europe

机译:欧洲免疫兽医药品的质量控制

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Medicinal products in Europe are under the strict control of many organisations headed by the European Directorate for the Quality of Medicines and HealthCare (EDQM) in Strasbourg and its related General European Official Medicines Control Laboratories (OMCLs) Network (GEON). The EDQM works in cooperation with the European Medicines Agency (EMA) and the World Health Organisation (WHO). All of these institutions have one main goal - to protect public health in Europe and around the world. One of the more important effects of the harmonisation of pharmaceutical law in Europe was the introduction of the mutual recognition principle for the Official Control Authority Batch Release (OCABR)/Official Batch Protocol Review (OBPR) certificates in the European Union. The National Veterinary Research Institute (NVRI) in Poland is an example of an OMCL laboratory within the Veterinary Batch Release Network (VBRN) that issues the European certificates. The NVRI is actively involved in the batch release of immunological veterinary medicinal products (IVMPs), with approximately 1,800 certificates for IVMPs issued per year. It is also one of only four veterinary OMCLs that perform Post Marketing Surveillance (PMS) studies including approximately 47 IVMPs per year. All the results of the testing data are sent to the Chief Veterinary Officer, and also to the electronic Network platforms of the EDQM, which enables transparent information exchange.
机译:欧洲的药品是严格控制斯特拉斯堡药品和医疗保健质量(EDQM)和其相关欧洲官方药品控制实验室(OMCLS)网络(Geon)的欧洲药品和医疗保健的批先院长的许多组织的严格控制。欧盟董事会与欧洲药物(EMA)和世界卫生组织(WHO)合作。所有这些机构都有一个主要目标 - 保护欧洲和世界各地的公共卫生。欧洲制药法协调的更重要影响之一是引入欧盟官方控制权批量发布(OCABR)/官方批量审查(OBPR)证书的互认原则。波兰国家兽医研究所(NVRI)是兽医批量发布网络(VBRN)内的OMCL实验室的一个例子,涉及欧洲证书。 NVRI积极参与免疫兽医药品(IVMP)的批量释放,每年发布的IVMPS约1,800证书。它也是仅执行营销监测(PMS)研究的四个兽医OMCL之一,包括每年约47个IVMPS。测试数据的所有结果都被送到首席兽医官员,也向EDQM的电子网络平台发送到EDQM,这使得透明信息交换。

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