Registration support


Core registration support entails preparation of the dossier sections on ecotoxicology and efate for the registration (or re-registration) of plant protection products. Our experts in this area have detailed knowledge of data requirements for the registration and re-registration of active substances and PPPs as specified in current EU legislation, country-specific regulations and current guidance documents. The strong technical knowledge of the registration support team ensures fast and effective work, coupled with reliable regulatory compliance

 

  • Check of completeness and data gap analysis 
  • Dossier preparation (environmental fate and ecotoxicology sections) for Annex I listing of new active substances and re-registration of active substances (Annex I Renewal) 
  • Preparation of the environmental fate and ecotoxicology sections of the zonal core dossiers and national addenda for product registration in the EU (Annex III, dRR B8 & B9) 
  • Preparation of dossiers for Mutual Recognition (between EU member states)
  • Continuous support of national registrations mainly in EU member states but also in other countries around the globe 
  • On-site support at sponsor facilities 
  • Bridging statements for demonstration of comparability of product formulations
  • Post-submission support

 

This expertise is augmented by a deep reservoir of in-house specialist knowledge provided by senior staff members, which can be mobilised to handle complex authority requests or other non-standard situations that may arise during the registration. You can read more about these specialised services here.



tier3 solutions GmbH Office

Kolberger Str. 61-63 | 51381 Leverkusen | Germany

Phone: +49 2171 55 997 0 | Fax: +49 2171 55 997 69 | E-mail: info|at|tier3.de

Managing Director: Dr. Christian Wolf

Trade Register: Cologne HRB 70506 | VAT-No. DE 274 359 609