Europe – Questions & Answers on implementation: Impact of the Article 5(3) scientific opinion on nitrosamines in human medicinal products

In November 2020 the CHMP adopted an Opinion concluding that the outcome of the Article 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group (EMEA/H/A-31/1471) should be aligned with the outcome of the Article 5(3) assessment on nitrosamines (EMEA/H/A5(3)/1490). The main change concerns the limits for N nitrosamines, which previously applied to the active ingredients and will now apply instead to the finished products.

In line with previous opinion, companies should have appropriate control strategies to prevent or limit the presence of nitrosamine impurities as much as possible and, where necessary, improve their manufacturing processes. Companies should also evaluate the risk of N-nitrosamines being present in their medicines and carry out appropriate tests when a risk has been identified…