Regulation (EC) No 726/2004 Article 25

Article 25

Each Member State shall ensure that all suspected serious adverse reactions occurring within their territory to a medicinal product for human use authorised in accordance with this Regulation which are brought to their attention are recorded and reported promptly to the Agency and the marketing authorisation holder, and no later than 15 days following receipt of the information. The Agency shall forward the information to the national pharmacovigilance systems set up in accordance with Article 102 of Directive 2001/83/EC.

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Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 25 of Regulation (EC) No 726/2004 (LawPlayer, data as of 2026-07-04)

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