Services

Regulatory Solutions provides a specialist service for both active substance approvals and product authorisations across Europe. We can provide a tailored service to meet your exact requirements.

 

Our services include:

• Provision of regulatory advice

• Organisation and planning of regulatory projects

• Data gap analysis to identify a regulatory strategy

• Placement and monitoring of regulatory studies

• Classification and labelling, including MSDS preparation

• Preparation, submission and follow-up of regulatory submissions

• Risk assessment

• Task Force co-ordination

Agrochemical active substances and plant protection products must first be registered before they can be used in Europe. Their use is controlled via Regulation (EC) No. 1107/2009, which entered into force on 14 June 2011. It aims to provide a harmonised and efficient system for European registration, and introduces the rules for the approval of active substance and the authorisation of plant protection products across Europe.

Active substances are approved centrally at EC level. For existing active substances there is an ongoing renewal programme, covered by the AIR projects. First an application for renewal should be submitted, followed by a supplementary dossier addressing changes in Regulatory requirements since the initial review.

New active substances first need to be approved in Europe via submission of a complete dossier.

We can help you with either new active substance approval or existing active substance renewal. At Regulatory Solutions we have many years of practical agrochemical registration experience, gained both in industry and in consultancy. We have assisted clients with the renewal of their active substances as well as first approval of new biopesticide active substances.

Products are authorised at national level. Products can generally only be authorised once an active substance is approved. Under Regulation (EC) No. 1107/2009 the zonal concept it introduced, whereby the EC is divided into 3 zones (Northern, Central and Southern) with the aim of facilitating work-sharing between countries within a zone. 

Regulatory Solutions can help you achieve product authorisations using the zonal system. We have several years of experience in writing the dRR dossiers, including study summaries and risk assessments that are required for national submission. We can also assist with developing a regulatory package and with post-submission support.