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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)

The Organisation for Professionals in Regulatory Affairs The Organisation for Professionals in Regulatory Affairs

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Initial Registration Strategy Procedures comparative table 28

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

Choice of RMS

Timeline: National procedure (210 days +/-) + 90 days MRP timetable

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

The Organisation for Professionals in Regulatory Affairs The Organisation for Professionals in Regulatory Affairs

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