CRED 8 Presentations

08/07/2024

Prescription status

● In MRP/DCP, it is not necessary to harmonise the prescription status

● Prescription status is formally not discussed in MRP/DCP

CMDh Task force on Self medication project to improve DCP/MRP for OTC products: CMDh Best Practice Guide for authorisation of non-prescription medicines in the decentralised and mutual recognition procedures (http://www.hma.eu/91.html)

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Initial Registration Strategy Procedures comparative table

MRP

DCP

A national license/MA should exist for the product anywhere in EU

There should NOT be a National license/MA for the product anywhere in EU at time of application by that MAH

RMS has to be the country where National license/MA already available Timeline: National procedure (210 days +/-) + 90 days MRP timetable

Choice of RMS

Timeline: 210 days timetable with provision of early closure

RMS assess the dossier before the CMS

RMS and CMS dossier assess the dossier in parallel

No clock stop during the procedure

There is a clock stop

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