On September 26th, 2019 the CMDh published the notice “Information on nitrosamines for marketing authorisation holders” asking to all Marketing Authorization Holders (MAHs) of human medicinal products containing chemically synthesised active pharmaceutical ingredients to evaluate the risk of the presence of nitrosamine impurities in their products. This includes generics and over-the counter (OTC) products.
The risk evaluation of all products should be concluded at the latest within 6 months of the publication of the CMDh notification, i.e. by March 26th, 2020.