Why Romania as RMS - TOPRA

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Why Romania as RMS - in the Applicants view • the size of Romanian pharmaceutical market (7/30) • limited availability of other NCAs to act as the RMS (9/30; fully booked till 2010-2011) • gained experience of the applicants with NMA authorization process • EU Legislation already implemented before accession, quality of assessment/trained assessors, received LoQ in finalised or pending MRP/DCP/National procedure applications) • MAs already granted in National Procedure ―> MRP 12
NMA preparations for acting as RMS (1) • establishing the date for starting the process: October 2008 • establishing of type of products to be accepted in the first instance taking into account NMA experience: 10. 1 applications of RPs which have not been authorised through CP • identifying of assessors (6 assessors + PTL) • NMA Team study visit at MPA, April 2008 • official announcement of HMA and CMDh (starting with October 2008) 13
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: Why Romania as RMS - in the NMA vie
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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