Why Romania as RMS - TOPRA

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Critical DCP/MRP issues for both NCA/Applicant (1) • expired data exclusivity • MA of RP not according to Acquis Communeautaire • NCAs and CMDh advice before starting a procedure • in force BPGs, SOPs, ICH Guidelines, NfG on BE, CMDh Recommendations, HBD List, not included in MAA • MAA requirements (copies, originally signed documents, e-CTD); updated information according to monthly News published on the HMA/CMDh website: www.hma.eu 20
Critical DCP/MRP issues for both NCA/Applicant (2) • submission of application in due time (Day -14); fees to be paid (in advance of submission in RO) • GMP, GLP, GCP compliance at Day -14/Day 106 • weak points of submitted MAA (validated process on commercial batches, incomplete stability studies, another BE study); availability of Applicant's responses; potential Plan B • legal b<strong>as</strong>e chosen according to current situation of RP in MSs (10.1; 10.2; 10.3) 21
Page 1 and 2: Agency and industry experience usin
Page 3 and 4: RMS essential role in MRP/DCP (1):
Page 5 and 6: APPLICANT`S DUTIES (1) • to searc
Page 7 and 8: APPLICANT`S DUTIES (3) • to be av
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: Current situation (before September
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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