Why Romania as RMS - TOPRA

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APPLICANT`S DUTIES (2) • to identify (in advance of MRP/DCP start) any PSRPH in published CMDh Referrals • to have one available (!) contact point during procedure (phone, fax, e-mail); to have an updated contact detail of ASMF Holder • to give RMS the required responses (pre-assessment) in due time • to produce all responses for invalidation issues and for comments/questions raised by RMS and CMSs 6
APPLICANT`S DUTIES (3) • to be available for a possible oral explanation in the CMDh • to circulate the agreed specifications of drug substance/product to the RMS and CMSs • to submit to NCAs accurate translations of the agreed product information at the End of Procedure/End of Referral 7
Page 1 and 2: Agency and industry experience usin
Page 3 and 4: RMS essential role in MRP/DCP (1):
Page 5: APPLICANT`S DUTIES (1) • to searc
Page 9 and 10: Why Romania as RMS - in the NMA vie
Page 11 and 12: Why Romania as RMS - in the NMA vie
Page 13 and 14: NMA preparations for acting as RMS
Page 15 and 16: Types of requests received for Roma
Page 17 and 18: NMA SOP for decision to act as RMS
Page 19 and 20: Current situation (before September
Page 21 and 22: Critical DCP/MRP issues for both NC
Page 23 and 24: Critical DCP/MRP issues for both NC
Page 25 and 26: Present circumstances to obtain a s
Page 27 and 28: Do`s: • carefully read the HMA/CM
Page 29 and 30: Questions 29

Why Romania as RMS - TOPRA

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