EU regulatory guide
CPSR, PIF and notification: the difference.
Three documents, constantly confused, never interchangeable. One is a signed safety assessment, one is a dossier, one is a filing. This page puts them side by side so you order the right thing in the right order.
Reviewed by Cassandra Maddocks, chemist & biochemist · last reviewed 26 July 2026
What is the difference between the CPSR, the PIF and the notification?
| CPSR | PIF | Notification | |
|---|---|---|---|
| What it is | A safety assessment in two parts, Part A data and Part B conclusion | The complete technical dossier for the product | An online filing recording the product for authorities |
| Legal basis | Article 10 and Annex I, Reg. 1223/2009 | Article 11, Reg. 1223/2009 | Article 13 (CPNP); UK regime for SCPN |
| Who produces it | A qualified safety assessor, who signs it | Assembled for the Responsible Person | Submitted by the Responsible Person only |
| Who sees it | Authorities, via the PIF, on request | Authorities, on request at the RP's address | Authorities and poison centres, via the portal |
| When it happens | After testing, before the PIF is complete | Before notification; kept 10 years after last batch | Before the product is placed on the market |
| Typical CIG price | $450 to $600 per product | Fixed price, see pricing | $150 per product |
Legal bases above sit in Regulation (EC) No 1223/2009; the EU filing runs through CPNP and the GB filing through the SCPN.
Why does the order matter?
The practical sequence for a first EU product: testing, then the CPSR from its inputs, then PIF assembly, then notification, with the Responsible Person appointed early because everything downstream runs through that role.
Which one do I actually need to buy?
Bundling is the honest efficiency: our launch pack covers the CPSR, PIF and notification for one product at a fixed $1,500, detailed on the pricing page. For your specific range, request a quote.
Primary sources cited in this guide. Regulatory status last verified 26 July 2026.
Put this into practice
