11 May 2012

IRISH MEDICINES BOARD (IRB): Guide to electronic submissions - Human medicines

The IMB now accepts and strongly recommends electronic submissions, either in eCTD format, non-eCTD (NeeS) format without paper copies or through the IMB’s online portal RIO. This applies to new applications; responses to validation queries and review of assessment questions, supplementary information, variations, renewals, periodic safety update reports (PSURs), active substance master files (ASMFs) / drug master files (DMFs). 

The IMB accepts electronic submissions as outlined in the Guide to electronic submissions - human medicines below. Companies who have a particular problem with submitting electronic applications in one of the agreed formats should contact the IMB at customerservice@imb.ie before making an application to discuss their situation.

To find more information about IRB electronic submissions guidance, please use the below mentioned weblink:


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