Legal Background
Why Are UFI Codes and PCN Notifications Required?
The UFI and PCN system improves emergency health responses across the European Union by enabling Poison Centres to access formulation data quickly, supporting accurate medical treatment, ensuring products circulate in full regulatory compliance, and providing transparency and traceability for competent authorities; for products under CLP Annex VIII, UFI assignment and PCN submission are legal requirements.
Failure to generate a UFI code or submit a PCN notification may result in:
- Rejection of products from the EU market
- Administrative actions or penalties by national authorities
- Product withdrawal or recall
- Commercial limitations with distributors and partners
- Damage to brand reputation and credibility
For this reason, accurate, complete, and up-to-date PCN submissions are critical for market access.