Reply To: Grace period for label changes


Aaron Staff
Participant

Reply To: Grace period for label changes

To the requestor, you asked if you can still use your supply after Jan2025 if you have transitioned to EU-CTR. The worst answer, to my understanding, is that you must have a label that is approved for Annex 6 in use after Jan2025. It is okay if it is also approved for Annex 13, you will not get penalized for having too much text like the Germany destruction instructions. BUT, to your point, after Jan2025, you have to have labels which are approved for Annex 6 in use.

There is no rush that as soon as you are approved for EU-CTR you must immediately move to your Annex 6 supply, you can still use the CTD supply until Jan2025.