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Responsible Person

What 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.

In this guide

  1. Define your product portfolio
  2. Identify available documents
  3. Agree on scope and coverage

Define your product portfolio

Identify the brand owner, manufacturer and products intended for sale. Separate product identities from packaging variants so the scope can be reviewed without assuming every SKU is a separate assessment.

Identify available documents

Make an inventory of the current safety report, product information file, formula, labels and supporting records. State which versions apply to the product that will actually be supplied.

Product-specific scope

The final requirements and suitability of existing evidence are determined for the actual formula, intended use and markets.

Agree on scope and coverage

Confirm the legal EU entity, written appointment and acceptance, covered products, effective period, label address and ongoing document access. Payment or quotation acceptance is not the same as appointment.

Sources to consult