PCN notification does not end with the submission of the notification application. After the notification is successfully done, you have to keep it updated.
Tracking modifications and updating notifications is just as crucial as is submitting them.
When do you have to update your PCN notification?
Let us look at a few examples when an update of the submitted PCN notification is required:
- addition of new information (adding a new trade name, adding a new UFI - for example when placing a new product with a new UFI and the composition remains the same, new packaging, new toxicological information)
- replacement of no longer relevant information with new information (for example new classification of the mixture following changes in classification criteria, new contact information for rapid access to additional product information)
Generating a new UFI and submitting a new PCN notification
- UFI depends on the composition of the mixture (chemistry context), not the product in the commercial context.
- If you change the mixture composition beyond the allowed range for relevant substances, a new UFI must be generated.
- You have to use a different formulation number when generating new UFIs – otherwise, the UFI would be identical to the previously generated one.
When do you have to generate new UFI?
A new UFI needed when one of the following changes to the composition occur:
- adding, substituting or deleting a component
- supplier changes UFI, and it has an impact on MiM
- change in concentration beyond the allowed variation
For example a component present in the mixture at 30%. Variation of +/- 5% requires an update. Update if new concentration ≤28.5% or ≥ 31.5%.
What do you have to do after updating your UFI?
- Change in UFI requires submission update
- Relabelling: Print UFI on the label or affix it
- Communicate new UFI in the supply chain
- For commercial reasons you can also assign a mixture a new additional UFI, but you still need to update
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