Modules 2, 3, 4 and 5 (quality, non- clinical and clinical data) for above mentioned applications may be submitted to the SIDC / Registration Unit as of 1 August 2009 on electronic media. eCTD format is recommended (for more information see http://esubmission.emea.europa.eu/), though NeeS format is acceptable as well. This applies for national as well as EU procedures.
In case that an applicant submits above mentioned documentation on an electronic media (CDs) only, a declaration stating that the applicant/ MAH shall submit a paper version upon SIDC request within 14 days is requested.
Number of electronic copies requested is 1 or 2:
Moduls 2 and 3 have to be provided either separately or as an additional copy.
19th February 2010
PharmDr. Ján M a z a g
director
