Anvisa – Informs the updates on the RDC 53/2015 and IN 258/2023 on qualified impurities is published
Anvisa (National Health Surveillance Agency) informs that RDC 821/2023 and IN 258/2023 was published on November 1, simplifying the qualification of impurities in pharmaceutical products. Listed impurities do not require a specific addition, while unlisted impurities require documentation for analysis. 

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If you need more information for drug regulatory issues, ELS can help with our registration services for your products.

Contact your local ELS consultant or via email info@elssolutions.pt

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