Directive 2001/83/EC of the European Parliament and of the… Article 107

Article 107

1. Where, as a result of the evaluation of pharmacovigilance data, a Member State considers that a marketing authorisation should be suspended, withdrawn or varied in accordance with the guidance referred to in Article 106(1), it shall forthwith inform the Agency, the other Member States and the marketing authorisation holder. 2. In case of urgency, the Member State concerned may suspend the marketing authorisation of a medicinal product, provided the Agency, the Commission and the other Member States are informed at the latest on the following working day.

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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 107 of Directive 2001/83/EC of the European Parliament and of the… (LawPlayer, data as of 2026-07-04)

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