The EU Responsible Person is the regulatory contact and compliance holder for the product in the EU. The Responsible Person must have access to the PIF, support authority communication and help ensure required compliance steps are completed before market placement. UK market placement requires a separate UK arrangement.
Practical compliance point
Documentation and notification must be completed before placing the product on the relevant market. Requirements must be checked against the actual formulation, label, intended use and target jurisdiction.
How AsCo Europe can help
AsCo Europe can review the available data, identify gaps, prepare or coordinate the required documentation, and support the correct EU and/or UK market placement workflow.