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Directive 2001/83/EC of the European Parliament and of the… Article 122

Directive 2001/83/EC of the European Parliament and of the… Article 122

Article 122

Member States shall take all appropriate measures to ensure that the competent authorities concerned communicate to each other such information as is appropriate to guarantee that the requirements for the manufacturing authorizations or marketing authorizations are fulfilled. Upon reasoned request, Member States shall forthwith communicate the reports referred to in Article 111(3) to the competent authorities of another Member State. If, after considering the reports, the Member State receiving the reports considers that it cannot accept the conclusions reached by the competent authorities of the Member State in which the report was established, it shall inform the competent authorities concerned of its reasons and may request further information. The Member States concerned shall use their best endeavours to reach agreement. If necessary, in the case of serious differences of opinion, the Commission shall be informed by one of the Member States concerned.

Read the full instrument → · Read this in context: TITLE XIII — GENERAL PROVISIONS →

Other provisions in TITLE XIII — GENERAL PROVISIONS

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 122 of Directive 2001/83/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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