# Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (Text with EEA relevance), Article 8: Annual reports

Extent: E+W+S+N.I.

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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Source: https://www.legislation.gov.uk/eudr/2005/61/article/8 (the official version)
Page: https://openlegislation.uk/eu-directive-2005-61/article-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.