Irish Medicines Board Announces Transition to Fully Electronic Submission System
Posted 14 May 2012 | By
The Irish Medicines Board (IMB) is announcing its adherence to a 2005 agreement between the Heads of Medicines Agencies to transition to a fully electronic system for submitting applications, including the electronic Common Technical Document (eCTD) and Non-eCTD electronic Submissions (NeeS).
IMB said in a statement the transition confers several advantages, including reduced costs, consistency of applications and information viewed across agencies, improved lifecycle management and improved ability to search and assess submissions.
IMB said in a statement it will "accept and strongly recommend electronic submissions," either in eCTD or NeeS format, and encourages all companies wishing to submit an application in a physical format to contact IMB to discuss the company's particular situation.
Physical submissions will still be accepted until further notice.
IMB - Guide to electronic submissions - human medicines