Preparation of Draft Registration Report (DRR) for product authorization

All Companies intending to place a Plant Protection Product (PPP) on the European market need to authorize such product according to Regulation (EC) 1107/2009.

The authorization process requires the submission of a draft Registration Report (dRR) to be evaluated by all concerned Member States (cMSs).

We offer our experience in the field to Companies interested in authorizing PPPs by supporting them in:

Data gap analysis and testing strategy development (including development of rationales for study waivers and expert statements where possible);
Study commissioning and monitoring;
Environmental and Human Health risk assessment;
Efficacy assessment;
Classification of mixtures according to CLP Regulation;
Preparation of EU product dossiers (draft Registration Reports – zonal authorisation) and submission to Competent Authorities. (This includes collecting and evaluating data for product authorization and the preparation of National Addenda for specific MSs, where necessary);
Liaison with the Authorities and technical Evaluation Bodies for both technical and regulatory issues;
Follow-up of the authorization process.

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