Plant Protection Products Regulation
The Plant Protection Products Regulation (EU) No. 1107/2009 came into force on June 14, 2011, and lays down the rules and procedures for the placing of protection products onto the market within the EU and introduces many new regulatory challenges.
The Regulation sets out comprehensive approval criteria for active substances at the EU level and new procedures for product assessment within a zonal authorization framework. It also provides the basis for an ambitious and comprehensive renewal programme for existing approved active substances (the ‘AIR’ programme). New data requirements for active substances and products have also been established and there is a continuing programme for establishing new technical and procedural guidance.
Whilst the regulation derives from the EU, authorization of plant protection products is the responsibility of each EU Member State. Despite ongoing efforts at harmonization and mutual recognition procedures, some Member States maintain different administrative, regulatory or data requirements (some of which are based on differences such as climate or soil type). These requirements and their constant change represent a challenge for companies wishing to place their plant protection products on the market.
TSG can help
- We offer a wealth of expertise, gained from industry, government, and research providing you with effective support and guidance for ensuring and gaining regulatory compliance for active substances and plant protection products
- Our multidisciplinary team of scientists, regulatory and registration specialists allows us to provide support across a diversity of areas, including study monitoring, task force management, dossier preparation, and CADDY services
- We have a proven record of achieving numerous successful regulatory outcomes with applications for new active substances and renewals of existing active substances (under the AIR programmes)
- We are experienced in all types of product authorizations (renewals under Art. 43, zonal applications under Art. 33, national authorizations and mutual recognitions)
- We have extensive experience in dealing with regulators and with our network of regional offices, we continue to provide an extensive pan-European product registration service
- We have an extensive pan-European infrastructure with offices in France, Spain, Germany, UK, Slovenia, Slovakia, Poland and Romania offering focused, local registration support
- We provide strong and proactive project management to ensure that our clients’ needs are identified and met in a timely manner