Directive 2004/27/EC of the European Parliament and of the… Article 10b

Article 10b

In the case of medicinal products containing active substances used in the composition of authorised medicinal products but not hitherto used in combination for therapeutic purposes, the results of new pre-clinical tests or new clinical trials relating to that combination shall be provided in accordance with Article 8(3)(i), but it shall not be necessary to provide scientific references relating to each individual active substance.

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Other provisions in Directive 2004/27/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 10b of Directive 2004/27/EC of the European Parliament and of the… (LawPlayer, data as of 2026-07-04)

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