How to choose an EU responsible person: nine questions to ask
Ask any responsible person nine questions before you sign a mandate. The answers separate a named, established practice that will stand behind your file from a mailbox address. No competitor is named here. Every question is one we answer ourselves.
The nine questions
| # | Ask them | A good answer | Ours |
|---|---|---|---|
| 1 | Are you established in the Union? | A named EU entity and address (Art. 4(1)) | Established in Belgium |
| 2 | Who signs Part B, and what qualifies them? | A named person with a qualification under Art. 10(2) | David Vandevoort, pharmacist (Master, KU Leuven; PhD, KU Leuven 2010) |
| 3 | Is your scope published, per price? | Published lines stating what each covers | Bands and lines on our pricing page |
| 4 | What would make you refuse to sign? | A written standard | A report that cannot be established is refused, not padded — you pay for the finding, not the signature |
| 5 | Where is my file kept, and how fast can you produce it? | At the address on the label, indexed and readily accessible (Art. 11(3)) | An indexed folder with hashes, and the gap list on the front |
| 6 | What happens when a rule changes? | They watch the registers and tell you | We watch the EU registers for rule changes that touch your product, and tell you when one does |
| 7 | Whose name and address goes on my label? | Theirs, as the designated responsible person (Art. 19(1)(a)) | Ours |
| 8 | Who submits the CPNP notification, and do I get the references? | The responsible person submits it (Art. 13(1)); you get the references | We do, and you get them |
| 9 | What happens if we part ways? | The file and the CPNP transfer are handed over, with a dated end to the mandate | How a change of responsible person works |
Check my product — free
Paste the product's public listing URL. We check which of the eight obligations are visibly met — free, while you wait — a screen of the public words, not a safety assessment.
No public page, or the list is only on the pack? Paste it instead
Why these nine
Establishment and signature (1, 2) are the two things the Regulation itself ties to a person: the responsible person has to be designated within the Union (Art. 4(1)), and the assessment has to be carried out by someone qualified under Art. 10(2). A provider who cannot name both has not answered the question you are paying for. What a CPSR is, and who may sign it →
Scope and refusal (3, 4) tell you what you are buying. A price without a stated scope cannot be compared, and a provider with no written reason to refuse has no standard you can hold them to.
The file, the label and the notification (5, 7, 8) are where the role shows up in practice: the file kept at the address on the label (Art. 11(3)), that address on your pack (Art. 19(1)(a)), and the notification submitted by the responsible person (Art. 13(1)). The PIF checklist → · Whose address goes on the label →
Rule changes and exit (6, 9) are what a responsible person does after the invoice. The re-signing work after a rule change is priced on our pricing page; being told it happened is inside the yearly fee.
Questions people ask
Is the cheapest responsible person the right one?
Price alone does not tell you. A very cheap report is one of two things: a template written against a fixed base recipe you must not deviate from, or a real assessment of a genuinely simple product where the floor of work really is low. Which one you have is visible from the report itself. Is a very cheap report safe to use? →
Can my manufacturer be my responsible person?
If it is established in the Union, yes: an EU manufacturer is the responsible person unless it designates someone else by written mandate (Art. 4(3)). A manufacturer outside the Union cannot hold the role.
Do the responsible person and the safety assessor have to be the same person?
Not necessarily. They can be. The responsible person has to ensure a report exists; Art. 10(2) governs who may produce it.
Tell us the product, the variants and the markets — a fixed quote in writing.