Directive 2001/83/EC of the European Parliament and of the… Article 44

Article 44

If the holder of the manufacturing authorization requests a change in any of the particulars referred to in points (a) and (b) of the first paragraph of Article 41, the time taken for the procedure relating to this request shall not exceed 30 days. In exceptional cases this period of time may be extended to 90 days.

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

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