This document provides information on the CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines.
In this version the following questions have been modified:
- 1.9. When in the step 1 template a potential risk for nitrosamines is identified as not all relevant data were available and later on it is clarified that there is actually no risk, may I submit updated templates, i.e. replace the “risk identified” template by a “no risk identified” template?
- 3.1. When should any necessary variations be submitted?
In the document you will find practical answers to lot of Nitrosamine’s ‘How should I do/What should I do’
CMDh_412_2019_Rev.18_07_2022_clean_-_PG_to_MAHs_on_nitrosamines.pdf (310.7 KB)
