ENC writes your registration dossier.
Once the data package is available, our consultants summarise each study in the dossier and write the risk assessment according to the relevant guidance. The aim of the dossier is to demonstrate that the Plant Protection Product, and the way it is intended to be used, is compliant with the decision-making criteria of the European authorities.
A dossier will be required for each PPP but it is also necessary to satisfy the data requirement for the active substance.
The nature of an active substance dossier will vary depending if the applicant is actively developing and defending an active substance or if the applicant just want to follow the lead of a main applicant and match the required data.
A dossier will be needed in the following circumstances.
- Approval of a new source of technical active substance.
- Approval of a new active substance.
- Renewal of active substances.
- Access to the active substance data.
- Authorization of a new product.
- Renewal of product authorization after renewal of an active substance.
- Extension of use of a registered product.
- Modification of a product registration.
– Preliminary notifications.
– Documents MCA (Active substance data).
– Documents MCP (dossier for representative product).
– Documents A to J (lists, notifications and miscellaneous information).
– Documents K (studies).
– Documents LCA – LCP (reference lists).
– Documents N (conclusions, endpoints, list of metabolites…).
See zonal registration
-Part B0 – Background.
-Part B1-B2 and B4 – Identity – physical and chemical properties.
-Part B3 – Efficacy.
-Part B5 – Method of Analyses.
-Part B6 – Toxicity.
-Part B7 – Residues.
-Part B8 – Environmental fate.
-Part B9 – Ecotoxicology.
-Part B10 – Groundwater metabolites.
|For a generic applicant.|
-Data matching table or Letter of Access.
Part A – Risk management – country specific.
If required: national part B addenda.