The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) have published a best practice guide for marketing authorisation applicants, covering multilingual packaging requirements for mutual recognition (MR) and decentralised procedure (DCP) products.
The guide may also be used for products under national applications if the product authorisation details, such as the summary of product characteristics (SmPC), have previously been harmonised.
“The establishment of multilingual packaging is an important mechanism for maintaining products in EU markets.”
Directive 2001/83/EC, Article 63 authorises the use of multilingual text, stipulating that the same information appears in all the languages used, except for national specific information captured within the ‘blue box’. Information that applies to all countries should be included in the main text.
Multilingual packaging should be considered at the beginning of an application to ensure a marketing authorisation can be achieved in a timely and efficient manner. Applicants must inform the relative Member States (MS) in the MR/DCP of their intention to propose multilingual packaging for the appropriate market. This can be done in the cover letter of the application. Applicants should consider the level of detail to be proposed in the harmonised text, testing of the wording in several languages on proposed packed sizes, and space constraints.
Multilingual packaging is only possible for products authorised through the MRP, DCP and national procedures if the medicinal product in the involved MS has:
- The same invented name and strength
- Harmonised SmPC, package leaflet and product labelling text
- The same legal status
The guideline then outlines the key principles which must be taken into consideration to ensure mock-ups are in an acceptable format.
However, this guidance may not be applicable in all aspects for all MS, therefore applicants are advised to consider the additional national guidance referenced in Annex 1 of the attached document. Currently, there are various successful initiatives to facilitate multilingual packages e.g. the Nordic, Baltic or BE procedures (referenced in Annex 1). Therefore this best practice guide is proposed where these procedures are not appropriate for the countries involved in developing the multilingual package.
To view the full guidance, click here.