09.07.2020 - CHMP opinion

EMA’s human medicines committee (CHMP) has issued an opinion requiring companies to take measures to limit the presence of nitrosamines in human medicines as much as possible and to ensure levels of these impurities do not exceed set limits.

17.09.2019 - Procedure started

The Committee for Medicinal Products for Human Use (CHMP) of the EMA will develop guidelines to avoid nitrosamine impurities in medicinal products for human use containing chemically synthesised active substances.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

EMA to provide guidance on avoiding nitrosamines in human medicines