Directive 2001/83/EC of the European Parliament and of the… Article 23
Directive 2001/83/EC of the European Parliament and of the… Article 23
Article 23
After an authorization has been issued, the authorization holder must, in respect of the methods of manufacture and control provided for in Article 8(3)(d) and (h), take account of scientific and technical progress and introduce any changes that may be required to enable the medicinal product to be manufactured and checked by means of generally accepted scientific methods.
These changes shall be subject to the approval of the competent authority of the Member State concerned.
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 23 of Directive 2001/83/EC of the European Parliament and of the… (LawPlayer, data as of 2026-07-04)
