Europe – CMDh : 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 countries should be included in the main text.
The establishment of multilingual packaging is an important mechanism for maintaining products in EU markets, particularly smaller markets. This document serves to assist applicants in creating multilingual packages. There are successful initiatives already in place to facilitate multilingual packages e.g. the Nordic, Baltic or BE procedures (see Annex 1 below), therefore the following guidance is proposed where these procedures are not appropriate for the countries involved in developing the multilingual package.
In the May 2019 CMDh plenary, during the joint industry/member states discussion, the willingness of member states to facilitate multilingual packaging, which is seen as helpful to maintain availability of medicines, for example in the context of Brexit, was highlighted. Industry were requested to share their experiences of developing and using multilingual labelling, for consideration when developing guidance in this area. This guidance has therefore been prepared incorporating the recommendations from industry and member states, for use as an information resource to applicants…