Regulatory Biological Assessment Dossiers (BADs / dRR section 7 summaries)
Eurofins Agroscience Services provides a full range of services leading to the compilation of draft registration reports (dRR) for agrochemical and biopesticides. The submission of efficacy data for any product is a requirement for member states in Europe and many other parts of the world. The data should be summarised and complete the objective of supporting label claims made and also correspond with the recommended use pattern. A Biological Assessment Dossier summarises the data from all efficacy and selectivity trials. Since the entry into force of the new Regulation (EC) No. 1107/2009, the approach is now a zonal submission procedure, meaning one dossier for all the member states of that specific zone and national addenda must only be used and justified for any national specific requirements. Efficacy data must be presented in the specified format which is provided by the competent authorities. Efficacy is also a requirement for Annex I inclusion of biocidal active substances in the EU. EU Member States require the submission of detailed efficacy data to support the product.
At EAS Group we help provide our clients with a strategy for trials programs (numbers and distribution) required for a zonal submission. Efficacy is a fundamental aspect for the successful registration of plant protection products, and on the basis of the trial data provided, the regulatory team at EAS Group will prepare a Biological Assessment Dossier (BAD) to the new Regulation (EC) No. 1107/2009. The risk of resistance to plant protection products can be assessed and, if appropriate, programs for risk management can be proposed in the context of official registration of plant protection products. We coordinate and successfully compile multi-use BADs for company task forces. We will liaise with Regulatory Authorities on behalf of the client, before and after submission.
You can expect:
- Advice on a cost effective efficacy program to comply with financial constraints
- Project manage efficacy testing programs from start to finish
- Experienced technical professionals solving issues from regulator's evaluating comments
Why EAS Group?
In brief, we offer a complete service which includes:
- GEP studies required for registration
- Creation of protocols complying with all relevant guidelines
- Immediate access to ARM data and results from in-house study management
- Peer review / critical gap analysis of existing data sets
Regulatory services include:
- Annex III dossier for agrochemicals, biocides and biopesticides
- Completeness checks and data gap analyses
- dRR summaries
- National addenda (if required) and EU permits
Eurofins Field Team Support
EAS Group field stations are strategically placed globally. Within EAS Group you will have unparalleled specialist capabilities which are supported by EAS Group local agronomists with the expertise of new and existing markets.
Please contact Adrian Cheshire for more information