The CMDh has agreed on an update of the Best Practice Guide (BPG) on multilingual packaging (MLP), in order to improve availability of medicines in smaller markets. The update includes a pilot exercise to explore whether it is feasible to implement a coordinated approach to preparation of multilingual packaging. The pilot is at this time limited to ongoing procedures identified by RMSs with input from the MLP working group, and a limited number of procedures on request to the RMS where a significant need has been identified by the MAH. The CMDh also adopted updates of the cover letter templates for the MAH to identify proposed MLP Member State clusters upfront, and thus improve visibility and involvement of the affected Member States in MLP procedures.



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