Guide to electronic submissions - human medicines
21 May 2013
It was agreed by the Heads of Medicines Agencies (HMA) in Reykjavik on 28 February 2005 that by an agreed end-2009 deadline, the European regulatory agencies must have the infrastructure and processes in place to handle electronic-only eCTD submissions to successfully support the related decision-making processes for the authorisation of medicinal products within the European Union.
The IMB has fully adopted the European Guidance for eCTD (electronic Common Technical Document) and NeeS (Non-eCTD electronic submissions). The transition to electronic submissions brings with it several advantages, not only the obvious reduction in printing, archiving and transportation costs, but also facilitates consistency in information viewed across agencies, the ability to manage the lifecycle of the product, and improved navigation and assessment of documentation.
RIO replaced by CESP, RIO the Irish Medicines Board's Regulatory Information system will not be available for applications from early February 2013. Please note that the tracking facility will still be available for applications submitted through RIO prior to this date. The IMB will accept online submissions from February 2013 through CESP (Common European Submission Portal) at cesp.hma.eu/. The Guide to Electronic Submissions - Human Medicines has been updated to reflect this change.
The IMB now accepts and strongly recommends electronic submissions, either in eCTD format, non-eCTD (NeeS) format without paper copies or through CESP. 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.
For more information on electronic submissions, please read the guide below:
Guide to electronic submissions - human medicines
The guide was revised in May 2013. To view the changes in the current version, click on the link below:
Guide to electronic submissions - human medicines - with changes highlighted