Plant Protection Products
Regulation (EC) No. 1107/2009 provides significant regulatory and scientific challenges for companies who wish to place their plant protection products on the market in the EU. New procedures, criteria, and data requirements make this regulatory area more complex than it has ever been. We have a proven track record of helping our clients to address these challenges from high level strategic advice through to preparing dossiers to meet EU requirements. We have significant repeat business from satisfied clients from small to medium sized companies to major multinationals. For example in the last two years, we have prepared some or all of approximately 20 dossiers for active substances and more than 50 dossiers for products, including the risk assessments. This gives us a strong practical understanding of EU and national requirements.
We have an extensive team of experts in all regulatory disciplines with previous experience working for regulatory authorities, Contract Research Organisations, agrochemical companies, and other consultancies at senior and more junior levels. This gives us an excellent mix of skills and perspectives and underpins delivery of cost effective solutions to regulatory needs and ensures that scientific and technical information is presented in the correct regulatory context.
Exponent can provide a complete service for the approval of active substances and authorisation of plant protection products including:
- Dossier preparation for active substances (new substance and renewals) and products (dRR dossiers) including study summaries, risk assessments, zonal dossiers and national addenda.
- Preparation of efficacy dossiers to the appropriate format including OECD and dRR format biological dossiers and dRR evaluation dossiers.
- Development of regulatory strategy and technical assistance to overcome regulatory challenges including data gap analyses, preliminary and higher tier risk assessments and submission scoping.
- Classification and labelling support including the preparation of technical dossiers to support harmonised classification and labelling proposals and representation at the Risk Assessment Committee of ECHA;
- Commissioning and monitoring of studies for safety and efficacy aspects of the dossier;
- Preparation of literature reviews in line with EU requirements using our internal Library Services;
- Preparation of dossiers for EU MRLs, Import Tolerances and JMPR;
- Task Force management for the renewal of active substances;
- Preparation of documents to support comparative assessment of products;
- Production and submission of dossiers in CADDY format;
- Assessment of active assessments against the various approval criteria (e.g. ‘cut-off’ criteria or candidate for substitution) and strategic advice where additional testing may help;
- Support at pre-submission meetings with the authorities with respect to active substance approvals and product authorisations;
- Full post-submission support and liaison with regulatory authorities to help clients manage the regulatory process through to conclusion.