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Nitrosamines in Human Medicines: EMA Advice

18 October 2019

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Guidance to industry has been published on the EMA website in relation to potential nitrosamine contamination of human medicinal products.

The following link will take you to the relevant pages on the EMA website: EMA advises companies on steps to take to avoid nitrosamines in human medicines | European Medicines Agency

EU MA Holders (in collaboration with API and drug product manufacturers) should conduct a nitrosamine risk evaluation within 6 months of the above published guidance (i.e. by 19th March 2020) and inform the concerned Competent Authorities when this is completed.

18 October 2019

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