Use of the less-than lifetime (LTL) concept or the use of interim limits

[Naiffer_Host]

I suggest revisiting the post where these changes are being discussed in depth.

Q&A revision 17 uploaded on EMA page

Hello, revision 17 of EMA Q&A is already uploded on EMA page. Changes: Amendment of Q&A 22 on approach to control presence of Nnitrosamine exceeding the AI while CAPAs are being implemented to extend the scope to authorised products for chronic use and clarify the applicable limits and exemptions. Amendment of Q&A 20 and Q&A 21on approach to control presence of nitrosamine while the AI is being established to clarify that as the AIs can be established with the new carcinogenic category approa…