CMDh Best Practice Guide on Multilingual packaging
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...
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