Why Romania as RMS - TOPRA
Why Romania as RMS - TOPRA
Why Romania as RMS - TOPRA
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Can a Referral be avoided<br />
• Statistics of Referrals: BE, lack of SPC harmonisation,<br />
Quality, Regulatory issues<br />
• Applicant: very well informed in advance, flexible in<br />
discussions with <strong>RMS</strong>, very well trained staff, pertinent<br />
response/justifications in c<strong>as</strong>e of a raised PSRPH<br />
• <strong>RMS</strong>: careful <strong>as</strong>sessment of a PSRPH, high quality ARs,<br />
correct interpretations of Guidelines, experience gained<br />
from other completed procedures of the same INN, finalised<br />
CMDh Referrals, CHMP Referrals, CHMP WP decisions<br />
24
Change language