Let’s say you tweak your formula or rebrand your product. Do you need a new PCN?
It depends on the change.
Here’s a quick guide without going into too much detail:
- Minor label update (such as new trade name)? New PCN not needed, but you do need to update the existing PCN.
- Change in intended use? An update may be needed to list the additional uses.
- New UFI or composition?
- If new UFI is only a part of marketing strategy, you can update the existing PCN with the new UFI.
- If composition changes out of possible allowed ranges, then new UFI and PCN are required.
Regulators expect consistency between your label, SDS, and PCN. If those don’t match, it can cause serious issues.
Pro tip: When in doubt, ask. It’s better to clarify than redo everything.
Unsure what counts as a new submission? We’re just a message away.
Disclaimer:
Information on this blog is prepared with utmost care, but it is not about (chemical) consulting, and the provider does not assume any responsibility or liability for the correctness, accuracy and up-to-dateness of published content. If you need advice for a specific case, you can write to us at bojan.dimic@bens-consulting.eu