This concerns the following sartans with a tetrazole ring:
The monographs are thus consistent with the latest regulatory recommendations issued by the Committee for Medicinal Products for Human Use (CHMP) on 13 November 2020 (see EMA nitrosamine website). Therefore, they were not published in the Pharmeuropa for public consultation. In addition, the monographs were implemented in a rapid revision process to best align the effective date with regulatory decisions.
The changes concern a new wording of the section "Production" and the deletion of the section on N-nitrosamine testing.
The monographs can be found in Supplements 10.4 and 10.5 in the download version. The PDF is available on the EDQM website. In the print version, you will find the monographs starting in Supplement 10.6.
Two other monographs have also been revised. They now contain recommendations for manufacturers on the handling and evaluation of nitrosamine impurities in active substances and medicinal products for human use:
These monographs will be published in Pharmeuropa 33.2 (April to June 2021).