MRL/Import tolerance applications

MRL and import tolerance applications can be a complex process, making the registration and submission quite challenging.
Staphyt, through its experience in Regulatory Affairs and Risk assessment with plant protection products, supports clients on the application of new MRLs or Import tolerances in the European Union or Great Britain. Indeed, following its withdrawal from the European Union, a new regulatory landscape for GB MRLs, with its own specificities, is applicable since January 1st 2021 in Great Britain.

From the setting and conduct of the residue studies to the final exchanges with the Member States and the publication of the Reasoned Opinion, Staphyt can accompany you throughout the whole process of MRL or Import tolerance application.
Our residue experts can provide advice and support during the different steps:

  • the setting and monitoring of the required studies that will be included in the dossier
  • the shipment of specimens to the GLP laboratory of your choice
  • the registration on the different official regulatory platforms;
  • the preparation, writing and submission of the MRL application form and the Evaluation report;
  • and finally, the follow-up with the authorities (exchanges with the Member state during the complementary/confirmatory phase for example).

We will be pleased to answer any questions you have regarding our services or to discuss your needs and build a plan that works for you. Please do not hesitate to contact us at contact@staphyt.com.