Commission Directive 2005/61/EC of 30 September 2005… Article 8

Annual reports

Article 8

Member States shall submit to the Commission an annual report, by 30 June of the following year, on the notification of serious adverse reactions and events received by the competent authority using the formats in Part D of Annex II and Part C of Annex III.

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Other provisions in Commission Directive 2005/61/EC of 30 September 2005…

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 8 of Commission Directive 2005/61/EC of 30 September 2005… (LawPlayer, data as of 2026-07-04)

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