My bookmarksSign up free

Directive 2001/83/EC of the European Parliament and of the… Article 58

Article 58

The inclusion in the packaging of all medicinal products of a package leaflet shall be obligatory unless all the information required by Articles 59 and 62 is directly conveyed on the outer packaging or on the immediate packaging.

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 58 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.

What to look at next