Why Romania as RMS - TOPRA
Why Romania as RMS - TOPRA
Why Romania as RMS - TOPRA
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<strong>Why</strong> <strong>Romania</strong> <strong>as</strong> <strong>RMS</strong> - in<br />
the Applicants view<br />
• the size of <strong>Romania</strong>n pharmaceutical market (7/30)<br />
• limited availability of other NCAs to act <strong>as</strong> the <strong>RMS</strong><br />
(9/30; fully booked till 2010-2011)<br />
• gained experience of the applicants with NMA<br />
authorization process<br />
• EU Legislation already implemented before accession,<br />
quality of <strong>as</strong>sessment/trained <strong>as</strong>sessors, received LoQ in<br />
finalised or pending MRP/DCP/National procedure<br />
applications)<br />
• MAs already granted in National Procedure ―> MRP<br />
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