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欧洲杀生物剂调节
在EU / EEA中，在寻求杀生物剂活性物质和杀生物产品的登记或授权时，可能需要考虑三个单独的立法 - BPR，CLP（分类，标签和包装）和覆盖范围。BPR是主要规范，由ECHA与个人评估成员国主管当局（ECAS）一起管理。在欧洲市场推出杀生物剂的第一步是有批准的活跃物质。经过积极物质批准后，您将申请特定的杀生物产品授权one of several possible routes。
Covance has a proven track record of supporting clients through BPR in Europe. By partnering with us, you will benefit from extensive insight and practical experience gained through both active substance approval and product authorization.
- Dedicated team of BPR specialists working within the wider team of regulatory scientists
- Comprehensive management of all the financial, legal and administrative aspects of handling a registration group
- Track record of managing active substance approvals through BPR submission – from Article 95 applications to full submissions
您的需求
导航BPR和注册组协议
Unlike REACH, ECHA does not mandate that companies work together to submit a single registration dossier for each biocidal active substance under BPR. However, many companies choose to do this as registration groups to help contain costs. Setting up a registration group means identifying other registrants, confirming equivalence of active substances and then negotiating to form the group or purchasing access to data through a letter of access. Navigating the legal, financial and administrative aspects of active substance approval can be time consuming and can slow your regulatory journey.
创建证据基础以支持您的物质的疗效和安全索赔
You may have a new active substance requiring approval under BPR or an existing substance that is part of the BPR review program. Either way, you need an up-to-date dossier that captures evidence of your substance’s efficacy and demonstrates safety to human health and the environment. The dossier must meet the criteria of the BPR, which has evolved; therefore, older substances submitted under previous legislation, may lack the right data.
Our Capabilities
Managing all the financial, legal and administrative aspects of your task force agreements
一种协作方法和积极主动沟通，形成了我们成功的注册群体领导的基岩。作为您的伴侣，我们可以协商合法和财务组建的联合协议，保护您的目标和利益。通过深入的监管知识，加上敏锐的关注工作队协议的所有技术和行政细节，您可以依靠我们保持轨道上的东西。Covance还可以在起草对我们现有托管的任务势力的访问信中，以便您可以获取所需的数据。
建立稳健和高质量的活性物质档案，与所有BPR要求和ECA需求保持一致
凭借多年的经验，与ECHA和不同的ECA一起使用，了解欧洲存在的诠释和变化的细微差别。这种洞察力使我们能够优化您的活跃物质提交，以确保顺利的监管段落。我们的团队预计可能的障碍，并与监管机构主动地解决这些问题。这让您按时和预算。
Covance can assemble a complete dossier for your substance. From identifying and filling data gaps with a tailored program of testing, supplied by our world-leading testing labs, through to completing an IUCLID dossier and submission via R4BP - This is an end-to-end service designed for both approval success and efficiency.
服务Covance undertake for active substances under BPR include:
- iuclid粉末料理为新的活性物质或第95条申请制备
- R4BP提交
- 关于现有活动批准的监管支持
- Tier I和II技术等效应用
- Transitional notifications
- 根据第95条的非欧盟公司欧盟代表
Keeping ahead of the BPR review program
由于欧盟杀生物产品规例528/2012于2013年9月生效，因此ECHA一直在审查注册的活性物质。审查计划将持续到2024年。我们的专业杀生物杀药剂监管团队通过BPR审查拥有丰富的支持活性物质的经验。通过巩固我们对法规优先事项的洞察力，我们可以预测可能的挑战并提前准备。这使您可以跟踪批准，并有助于最大限度地减少延迟。