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Directive 2001/20/EC of the European Parliament and of the… Article 18

Directive 2001/20/EC of the European Parliament and of the… Article 18

Guidance concerning reports

Article 18

The Commission, in consultation with the Agency, Member States and interested parties, shall draw up and publish detailed guidance on the collection, verification and presentation of adverse event/reaction reports, together with decoding procedures for unexpected serious adverse reactions.

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Other provisions in Directive 2001/20/EC of the European Parliament and of the…

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 18 of Directive 2001/20/EC of the European Parliament and of the… (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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