The main change to the updated Best Practice Guide (BPG) document (Rev. 5) is to reflect the success of the Multilingual Packaging pilot which took place 2020-2024.
To improve the availability of medicinal products in the EU, especially in so called "small markets”, the pilot facilitated the preparation of an ‘EU full/reduced harmonised labelling text’ during the EU procedural timelines to expedite the agreement of multilingual packs in the national phase of procedures.
Due to the engagement with the pilot, it has now been agreed to move from a pilot basis to a standard process. Therefore, EU reduced harmonised labelling text can now be prepared on a voluntary basis within new DC/MR procedures, within line extensions, and using MR Art. 61.3 procedures.
The cover letter template for new applications in MRP/DCP and the notification form for Art. 61.3 procedures are also updated to reflect this agreement.
Applicants are reminded that the BPG also provides useful general recommendations and examples on how to prepare multilingual packs and links to national guidance.
The updated BPG will be published on the CMDh website under “Procedural Guidance > Application for MA”.
The updated cover letter template for new application will be published under “Templates > Application for MA”.
The updated template for Art. 61.3 notifications will be published under “Procedural guidance > Art. 61.3 procedure”.
