Practical guides for your EU launch
Understand the documentation and decisions behind a coordinated market-entry process.
CPNP Notification Is Not EU Product Approval
A CPNP submission records product information. It does not replace a safety assessment, a complete dossier or an appointed Responsible Person.
Read guideWhat to Prepare Before Requesting an EU Responsible Person
The initial review starts with your product list, current safety documentation, labels and intended markets. Missing information changes the scope of work.
Read guideCPSR and PIF: What Each File Contains
The CPSR addresses safety assessment. The PIF brings together the product information and supporting documentation, including the safety report.
Read guideChanging 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.
Read guideEU Cosmetic Label Review: Information and Claims
Prepare the complete artwork and identify the intended countries of sale. Claims need to be considered alongside the evidence supporting them.
Read guideOne-Off Launch Costs and Annual RP Fees
Separate the launch work from continuing Responsible Person coverage. Tests, translations and taxes may be additional to the service estimate.
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