Changing your responsible person: the mandate, CPNP, the file and the label
Changing your responsible person touches three things the Regulation ties to that person: the CPNP notification, which names them (Art. 13(1)(b), Reg. (EC) 1223/2009); the product information file, which is kept at their address (Art. 11(3)); and the label, which carries their name and address (Art. 19(1)(a)). Each has to follow the change.
The new appointment
A responsible person other than the one Art. 4 names by default is designated by written mandate, and accepts in writing (Art. 4(3)–(6)). A mandate will be accepted here only in writing, only for products whose file we hold, and only where we are prepared to defend what is in it. So a switch to us starts with a review of your file. How the role works →
The CPNP notification
The notification includes "the name and address of the responsible person where the product information file is made readily accessible" (Art. 13(1)(b)). And "where any of the information set out in paragraphs 1, 3 and 4 changes, the responsible person or the distributor shall provide an update without delay" (Art. 13(7)).
In the portal, the Commission's CPNP user manual describes the handover this way:
- The outgoing responsible person uses the Admin menu option Copy your products to another Responsible Person.
- A copy of each selected product is saved in draft under the new responsible person. Everything is copied except the packaging and labelling information and the contact person details.
- The new responsible person adds the new label, bearing its own name and address, and its contact person, and submits.
If the outgoing responsible person will not make the copy, the new one notifies the product afresh. The notification cannot wait for their cooperation. How CPNP notification 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
The product information file
The file is kept at the responsible person's address indicated on the label, readily accessible (Art. 11(3)). When the responsible person changes, the file moves with the role. What the file must contain →
The label, and stock already printed
The pack must carry the new responsible person's name and address (Art. 19(1)(a)). Whose address goes on the label →
We could not find a transition period for a change of responsible person in Regulation (EC) 1223/2009, or official guidance that sets one. Art. 19(1) ties the label requirements to products being made available on the market, not only to the moment of placing. So plan the switch so relabelled stock is ready when the new notification goes live, and where old stock is still in the chain, ask the competent authority rather than assume.
What to get in writing from the outgoing responsible person
- The complete product information file, including the signed safety report.
- The CPNP transfer done, or at least the notification references.
- Supplier documents: specifications, certificates of analysis, allergen statements, the GMP statement.
- Any undesirable-effect reports on record.
- A dated end to the old mandate — so there is never a day with no responsible person, or with two.
Questions people ask
Do I need a new CPSR when I change responsible person?
Not because the responsible person changed. The report belongs to the product (Art. 10(1)). But a responsible person has to be able to stand behind the file it holds, so we review it before accepting a mandate. If the report cannot be traced to the documents in the file, or the signatory cannot be reached, it is re-done.
How long does a switch take?
Two parts. Getting the file and the CPNP transfer from the outgoing responsible person, which depends on them; and our review of the file, which starts when it lands.
Does my old responsible person have to cooperate?
For the CPNP copy, it helps: the transfer is made from their account. If they will not make it, the new responsible person notifies the product afresh.
Tell us the product, the variants and the markets — a fixed quote in writing.