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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).

Read the full instrument → · Read this in context: TITLE V — LABELLING AND PACKAGE LEAFLET →

Other provisions in TITLE V — LABELLING AND PACKAGE LEAFLET

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)

© 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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