Why Romania as RMS - TOPRA
Why Romania as RMS - TOPRA
Why Romania as RMS - TOPRA
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Don`ts:<br />
• keep insufficiently informed on regulatory/scientific <strong>as</strong>pects<br />
of your MAA<br />
• submit incompletely developed MAA<br />
• submit delayed responses during procedure<br />
• <strong>as</strong>sail the <strong>RMS</strong> with minor questions<br />
• minimise any <strong>RMS</strong> concern regarding the proposed/ongoing<br />
procedure<br />
• be unavailable <strong>as</strong> a PTL at key days of procedure<br />
• be inflexible to any <strong>RMS</strong>/CMSs proposals<br />
• submit poor quality and delayed translations<br />
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