# Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Division 1.3.2: Labelling and package leaflet

Extent: E+W+S+N.I.

A proposed labelling text for immediate and outer packaging as well as for the package leaflet shall be provided. These shall be in accordance with all mandatory items listed in Title V on the labelling of medicinal products for human use (Article 63) and on package leaflet (Article 59).

---
Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/I/division/1/division/1.3/division/1.3.2 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-1/division-1.3/division-1.3.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.