CMDh Best Practice Guide on Multilingual Packaging

On 22 October 2021 the Coordination Group for Mutual Recognition and Decentralized Procedures—Human (CMDh) updated the best practice guide on multilingual packaging.

‘Multilingual packaging’ refers to the use of two or more languages for at least one component of the packaging material for a medicinal product e.g., immediate and/or outer packaging and/or package leaflet or for all components.

Directive 2001/83/EC, Article 63 permits the use of multilingual text, with the proviso that the same information appears in all the languages used. The exception to this is national specific information captured within the ‘blue box’. Information that applies to all Member States (MSs) should be included in the main text.

The establishment of multilingual packaging is an important mechanism for maintaining medicinal products in EU markets, especially in so called “small markets”. This document serves to assist applicants in creating a multilingual package. There are successful initiatives already in place to facilitate multilingual packages e.g., the Nordic, Baltic or BE procedures (see Annex 1), therefore the following guidance is intended to be complementary to those procedures, in order to extend use of multilingual packaging in MSs where those procedures are not appropriate for the countries involved in the multilingual package. Other initiatives ongoing, for example electronic product information (ePI) projects are also complementary to multilingual packaging to ensure availability of medicines.

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