Directive 2001/83/EC of the European Parliament and of the… Article 65
Directive 2001/83/EC of the European Parliament and of the… Article 65
Article 65
As necessary, the Commission shall publish guidelines concerning in particular:
- the formulation of certain special warnings for certain categories of medicinal products,
- the particular information needs relating to self-medication,
- the legibility of particulars on the labelling and package leaflet,
- methods for the identification and authentication of medicinal products,
- the list of excipients which must feature on the labelling of medicinal products and the way these excipients must be indicated.
These guidelines shall be adopted in the form of a Directive, in accordance with the procedure referred to in Article 121(2).
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 65 of Directive 2001/83/EC of the European Parliament and of the… (LawPlayer, data as of 2026-07-04)