Changing Your EU Responsible Person
A transfer needs an agreed effective date, access to existing records and a coordinated plan for the label and notification information.
In this guide
Audit existing records
Establish what current files exist, who holds them and whether they apply to the actual product. Access to a notification reference alone does not establish access to the underlying dossier.
Plan the handover
Agree responsibilities and effective dates with the parties involved. Review the label address and notification information that need to reflect the new arrangements.
The final requirements and suitability of existing evidence are determined for the actual formula, intended use and markets.
Keep the transition documented
Retain the accepted mandate, product list, versions, handover record and correspondence. A transfer should not create an undocumented gap between responsibilities.