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 the<br />
NMA view (1)<br />
• EU Legislation already implemented before the date of<br />
EU accession: Title XVII, The Medicinal Product of Law<br />
95/July 2006 (transposing Directive 2001/83/EC)<br />
• NCA provided with sufficient and professionally well<br />
trained staff able to carry out this activity<br />
• Familiarisation with European legislation and procedures<br />
<strong>as</strong> early <strong>as</strong> 1999 in the PERF Program frame and practice<br />
of CADREAC simplified procedures<br />
• NMA experts already actively involved in EMEA/CHMP<br />
WP activities<br />
• Key staff availability to communicate with interested<br />
parties during the entire procedure duration<br />
8
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