The Regulatory Environment
The Plant Protection Products Regulation (EU) No. 1107/2009 came into force on 14 June 2011. It replaced Directive 91/414/EEC. This legislation 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 authorisation 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.
TSGE’s wealth of expertise, gained from industry, government and research, allows us to provide 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.
TSGE has 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 also experienced in all types of product authorisations (renewals under Art. 43, zonal applications under Art. 33, national authorisations 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 believe that proactive project management is essential to ensure that our clients’ needs are identified and met in a timely manner. We provide dedicated project managers who are committed to effective communication and project implementation.
TSGE has invested in and developed a pan-European infrastructure to meet those challenges presented by differing requirements across the Union. The TSGE group has offices in the UK, Ireland, France, Spain, Germany, Slovenia, Slovakia, Poland, Hungary and Romania offering focused, local registration support.
Our success has been achieved based on the understanding that no one individual or organisation can manage the authorisation of a plant protection or biocidal product effectively throughout Europe without local knowledge of procedures, culture and language. Our managers and registration professionals in the regional offices have the necessary regulatory skills and are experienced, approachable and dependable.
Should you wish to discuss any of our services, please contact us.
- Strategic advice & guidance
- Data Gap Analysis (completeness checks)
- Dossier preparation and submission
- Liaison with Regulatory Authorities
- Task Force Management
- Preparation of Biological Assessment Dossiers
- Preparation of Product Labels (CLP & GHS)
- Preparation of MSDSs
- Preparation of expert reports and waivers
- Human health and environmental risk assessments
- Study design and monitoring
- Due diligence audits