Kerona Scientific specialises in providing regulatory services to the plant protection sector.
The European regulatory system for plant protection products consists of two steps – first the active substance is approved at European level, then the plant protection products are authorised at Member State level. For approval of active substances, an allocated Rapporteur Member State (RMS) drafts the evaluation of the properties, and following peer review by all the other Member States and possible evaluation by the European Food Safety Authority (EFSA) a list of end-points is finalized which allows regulators and industry to conduct risk assessments using commonly agreed input parameters (the list of end-points). A work programme (the Annex I Renewal or ‘AIR’ programs) is in place to manage the renewal of the approvals at the end of the 10 year inclusion period. We are involved in a range of AIR projects on behalf of our clients.
Regulation (EC) No 1107/2009 is the legal framework in the EU setting out the rules, requirements, procedures and timeframes governing the placing of plant protection products on the market. The Regulation lays down the basis for common decision-making criteria (the Uniform Principles) which must be taken into consideration in the granting of product authorisations. To reduce the workload on industry and regulators and harmonise work sharing practices between Member States, the Regulation allows Mutual Recognition (MR) of an authorization within three defined zones, North, Central and South. We prepare full Annex III zonal dRR dossiers, and MR applications within zones.
Kerona Scientific offers a wide range of regulatory services for the plant protection sector. These include:
- Data matching evaluations
- Project management of complete European regulatory programmes
- Development of an EU-wide regulatory strategy and programme of study generation
- Strategic regulatory advice
- Task force participation and management
- Study commissioning and monitoring
- Management of field trial programmes (generation of efficacy and residue data)
- Assistance with data access negotiations
- Representation with the European authorities, both at European Commission level and also at national Member State level
- Preparation of full zonal dRR dossiers and “national addenda”
- Preparation of MR Applications and relevant National Addenda
- Preparation of efficacy dossiers (biological assessment dossiers – BAD)
- Preparation of technical equivalence applications
- Risk assessments (human health, consumer, ecotoxicological)
- Preparation of SDS and product labels
- Reclassification of products to CLP
- Submission of national generic (‘me-too’) applications e.g. ‘preparation bis’
- AIR management and submissions
Data matching checks for the EU are a very specialised skill, and require a unique combination of knowledge and industry experience.
A two-tiered approach is used in order to assess the equivalence of different sources of technical materials.
We are specialists in advising clients on successful strategies for the EU, ranging from the minimalist ‘me-too’ approach to the generation of full Annex III data packages.
The correct management of study commissioning programmes is vital to ensure timelines are met and the data is of the required quality.