PharmacovigilanceOfficial

EMA publishes Q&A for MAHs on CHMP nitrosamine opinion under Article 5(3)

🇪🇺 EMA · Thu 05 Nov 2026

The EU regulator has issued a questions-and-answers document for marketing authorisation holders and applicants on the CHMP opinion in the nitrosamine impurities referral, reference EMEA-H-A5(3)-1490.

The European Medicines Agency (EMA) has published a questions-and-answers document aimed at marketing authorisation holders and applicants. It relates to the CHMP opinion issued under the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. The procedure is listed under reference EMEA-H-A5(3)-1490, and the document is dated 5 November 2026.

The full text of the document was not available at the time of writing, so details of its individual questions and answers, and of any expectations or timelines it sets out, cannot be reported here. The title makes clear that the audience is companies holding or seeking EU marketing authorisations.

By way of context, Article 5(3) of Regulation (EC) No 726/2004 provides for the CHMP to give a scientific opinion on any matter concerning the evaluation of medicinal products for human use, when requested by the European Commission or the EMA's Executive Director. Companies should consult the EMA publication directly for the content of the Q&A.

What it means for your team

  • Regulatory affairs teams should read the full Q&A on the EMA website and check it against current nitrosamine risk-assessment and control strategies.
  • Quality teams should confirm whether the CHMP opinion and the Q&A call for changes to existing documentation or processes.
  • Applicants with pending submissions should check whether the document affects what is expected in their dossiers.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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