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Information for marketing authorisation holders: EMA finalises opinion on presence of nitrosamines in medicines

10.07.2020
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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 far as possible and to ensure levels of these impurities do not exceed set limits.

The measures will ensure that nitrosamines are either not present or are present below levels identified to protect public health.

Companies will be required to have appropriate control strategies to prevent or limit the presence of these impurities and, where necessary, improve their manufacturing processes.

Companies will also have to evaluate the risk of nitrosamines being present in medicines and carry out appropriate tests if a risk is identified.

 

According to the CHMP scientific opinion reviewing biological medicines in addition to medicines containing chemically synthesised active substances is recommended:

CHMP assessment report

 

Updated instructions for marketing authorisation holders will be available soon, based on the CHMP opinion. Until then, companies involved in the current call for review should continue to follow the current instructions and timelines.

 

For further information: EMA webpage

In case of nitrosamine related questions please contact: nitrosamines@ravimiamet.ee