关于将购买力平价纳入欧洲单一市场的立法载于第1107/2009号法规（EC），第283/2013号法规（EU）和第284/2013号法规（EU）中包含了有关购买力平价和购买力平价的具体数据要求。ASs的授权一般在十年后到期。为了使购买力平价能够继续进行营销和销售，必须寻求ASs授权的续期。此更新程序包含在Commission implementing Regulation (EU) No. 844/2012and is a European-level process.
Article 43 of Regulation (EC) No. 1107/2009 also provides the framework for the renewal of PPPs following the re-approval of an AS. This process is further elaborated on in aEuropean Commission guidance document. 购买力平价的更新是欧洲各成员国的责任。
更新计划
The programs for renewal of ASs in the EU are known as the AIR (Annex I Renewal) programs. ASs are assigned to a program, group and/or batch, based on their expiration dates and level of priority, in order to manage and spread the workload of the renewal process. The AIR programs also assign each AS a ‘Rapporteur Member State’ (RMS) to undertake the task of evaluating the renewal application.
有四个空中计划，如下表所示。
Details of the latest updates for renewal programs, AIR3 and AIR4, can be found on theEC website.
时间表和延期
For the current AIR4 substances, applicants must apply for renewal three years before the expiration date of an approved AS. Article 17 of Regulation 1107/2009 allows for extensions to the expiration dates of ASs, where it would not be possible to take a decision before the current expiration date, for reasons beyond the control of the applicant.
需要这些扩展的主要原因是：
- delays in assessment
- delays in decision-making – this is true for highly complex cases
- facilitation of the review through the Member States by balancing capacity – this is the case for AIR4.
空气更新过程
- Application (36 months before expiration)
Registrantssubmit an applicationcontaining limited information to indicate their intent of submitting a dossier to pursue active substance renewal.
- Application review
RMS conducts admissibility check. Registrant must respond within 14 days to calls for missing information.
- Submission (30 months before expiration)
Registrants create and submit a renewal dossier. For most ASs, the dossier must be submitted 6 months post application. For AIR4, some groups’ expiration dates have been extended by 1 to 3 years to allow more time for dossier submission.
- RAR评估（提交后12个月发布RAR）
RMS进行初步审查检查；注册人必须在14天内回复任何数据请求。续期评估报告草案（RAR）在提交档案12个月后发布。可要求提供补充资料。
- Peer-review (Review 8.5 – 11 months)
The RAR is passed to the European Food Safety Authority for publication and consultation.
- Renewal decision (~9 months duration)
最后的决定是由食物链和动物健康常务委员会投票决定的。委员会正式通过了续约，并公布了结果。
Other Important Elements of EU AS Review
Literature review：Covance可以访问许多免费和订阅数据库，允许进行符合EFSA指南. 采取分层方法，以确定那些既相关又可靠的文件，因此值得在更新档案中纳入和考虑结果。
统一分类和标签（CLH）屁股的责任是欧洲化学品管理局(ECHA). Covance is able to prepare dossiers (including IUCLID technical dossiers) for CLH under Regulation (EC) No. 1272/2008 (CLP Regulation), prepare expert statements on technical and scientific issues regarding toxicity of ASs and support customers at ECHA risk assessment committee meetings.
Maximum residue levels (MRLs): It is important to have appropriate MRLs (and/or import tolerances [ITs]) in place for all uses, not just the representative uses included in the renewal dossier. MRL application and setting is covered by Regulation (EC) No. 396/2005. Covance is able to prepare the specific addendum to the renewal dossier if new or amended MRLs/ITs are required.
Everywhere you go, crop protection businesses face an ever-changing commercial and regulatory landscape. But with a good CRO in place, you can supercharge your time-to-market.
最后的博客系列”的简单步骤Successful Active Substance Renewal” provides practical advice to tackle the renewal process.
了解更多关于“保存生命周期：更新现有的植物保护活性物质”下载这本内容丰富的电子书。
About the author
Gary started his career at Covance in 1985 and is currently the Business Lead Consultant for Crop Protection. As business lead, Gary provides regulatory advice to Covance’s clients to ensure their programs of work and applications for active substance approval or product registration meet the highest possible scientific and regulatory standards set by global authorities.
Covance provides essential research services, models and products for pharmaceutical, crop protection, and chemical companies, as well as universities, governments, and other research organizations. For more information about Covance’s regulatory services for crop protection,click here.
