Heads of Medicines Agencies publishes practical guidance on nitrosamines

In late October 2019, the Co-ordination Group for Mutual Recognition and Decentralised procedures – Human (CMDh) of the Heads of Medicines Agencies (HMA) published a practical guidance on nitrosamines. The guidance is addressed to marketing authorisations holders (MAHs) of products medicinal products authorised nationally in the EU Member States and through the mutual recognition and decentralised procedures. The guidance provides the steps to be followed to evaluate the risk of the presence of nitrosamine impurities in human medicinal products. The guidance includes the contact details of the competent authorities of the individual EU Member States and their published guidance in Annex.

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