EDQM - European Pharmacopeia - Feedback Nitrosamines

Pharmaeuropa 36.1 released!
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 36.1 is 31 March 2024 .

It is therefore extremely important that users provide feedback on such drafts.

Comments made after the adoption of the text and/or publication in the Ph. Eur. will be too late to be considered. Users may then be in a position where their product is not compliant with the Ph. Eur. monograph, which is a legal standard in Europe. This could ultimately lead to a situation where a product can no longer be marketed in Europe.

image

https://pharmeuropa.edqm.eu/app/phpa/content/issue36-1/20542E.htm

@trust_user_a @trust_user_b @trust_user_c @trust_user_d

12 Likes

Dear Naiffer,
thank you very much for the information.
I have to comment that this text is an updated of a quite old one and refers to the ‘‘small’’ nitrosamines with established limits.
It is mainly focus on the analytical technics of their quantification.
I do not think that make any difference to the present situation.
I attached the file here also, in case someone could not open the link
20542E.pdf (1.2 MB)
thank you

5 Likes

Thank you for sharing the update on Pharmaeuropa 36.1 release. It’s crucial for stakeholders to provide feedback before the March 31, 2024 deadline to ensure compliance with the European Pharmacopoeia standards. The link you provided contains additional details.

Thanks for the heads up. We’ll review Pharmaeuropa 36.1 and provide feedback by March 31, 2024. Appreciate your diligence in keeping us informed.