EMA Nitrosamines Q&A

Date

July 25, 2024

Category

EU Regulations

Description

Revision 21 of the EMA Q&A on Nitrosamines was published on 19 July 2024. This revision updates the following Q&As:

8, How should confirmatory tests be conducted by MAHs and manufacturers?
9, What are the requirements of the analytical method(s)?
10, Which limits apply for nitrosamines in medicinal products?
14, What is the approach for new and ongoing marketing authorisation applications (MAA)?
15, When should a test for nitrosamines be included in the MA dossier?
16, What are the responsibilities of MAHs for APIs with CEPs or ASMFs?