A primary goal of the regulation is to ensure PPPs placed on the market are safe for humans, animals and the environment, while also ensuring they have been demonstrated to be sufficiently effective. To achieve this, the regulation establishes a two-stage process to registration of PPPs, including:
- EU-wide Active Substance Approval: Any active substance that is to be used in a PPP must first have been approved at EU level.
- national authorisation of the PPP: Following approval of an active substance, any PPPs containing that active substance must first be authorised for use in the EU states where it is to be placed on the market.
Supporting active substance approvals and gaining PPP authorisations can be lengthy and complex processes with comprehensive packages of technical information on the active substance and PPP being required to be generated by applicants to support registration. While the PPPR aims to harmonise rules for bringing PPPs to market across the EU, many Member States have nation-specific requirements that must be addressed as part of the PPP authorisation process.
Enviresearch’s diverse team of regulatory specialists and scientists, with backgrounds from agrochemical manufacturers, chemical regulators and research institutions, has been routinely supporting the agrochemicals industry with PPP registrations since the introduction of the PPPR in June 2011. Our team will work with you to develop a flexible and tailored service package to support each step of your pathway to successful authorisation of your PPPs, covering:
- regulatory strategy development for authorisation of PPPs in Member States across northern, central and southern EU zones
- project management for each step of the regulatory pathway to gaining PPP authorisation
- complete data gap analysis of active substance and product data packages, including assistance in devising and implementing strategies to address identified gaps
- technical support in the analysis, interpretation and reporting of active substance and product data in the appropriate regulatory context and specific to the intended use patterns of the product
- performing all human health and environmental risk assessments required to support product authorisation
- providing full dossier preparation and submission to support new product authorisations, Article 43 product renewals, mutual recognition and label extensions
- providing full dossier preparation and submission support for technical equivalence applications for new active substance sources for use in PPPs.