Support on National dossiers

Regulation 1107/2009 divides Eu into three zones for PPP evaluation and authorisation:
  • Northern zone
  • Central zone
  • Southern zone
Applications are evaluated on a zonal basis, but for some uses the EU is considered a single zone and a single Member State can evaluate a PPP on behalf of the entire EU; these uses are greenhouse uses, post-harvest treatments, treatment of empty storage rooms or containers and seed treatments And designated zRMS assess applications on behalf of other countries in their zone (generally, openfield uses) and sometimes on behalf of all zones (protected and indoor uses). DEVREG services include:
  • Preparation of zonal dossiers
  • Liaison with the zonal/interzonal rapporteur Member State (zRMS)
  • Mutual recognition applications in other EU countries
  • Response to Member State comments and data requests
  • Communications with Authorities, including Rapporteur Member States (zRMS/izRMS),  National competent authorities (ANSES, MAPA, DGAV, BVL, Ctgb, etc.)
  • Support during peer review and expert meetings
Coverning a signification number of EU Member States, directly by our technical and regulatory staff or through national consultants with high expertise on these regulatory areas, manage and follow submissions, etc. DEVREG also provide Post-registration support, including
  • Label compilation and compliance with nacional requirements
  • MSDS compilation according current and in force Regulations
  • Monitoring of studies (e.g. environmental and residue studies), as post-registration requirements
  • Amendment and modification of national authorisations (e.g. GAP changes, fdormulation updates, non-significant composition changes, etc.)
  • Renewal applications (art. 43 of Regulation 1107/2009)
  • Collaboration with Specialized Law Firms & Compliance Providers, for legal support, regulatory interpretation, appeal processes, etc.