From 1 March 2014, the use of the eSubmission Gateway and/or the Web Client will become mandatory for all electronic Common Technical Document (eCTD) submissions through the centralised procedure. After this date, the European Medicines Agency will no longer accept esubmissions on CD or DVD. This will apply to all types of eCTD submissions for human medicines. More information and the statement of intent are available at the eSubmission Gateway and Web Client page .
Guidance on How to submit Periodic Safety Update Reports (PSURs) for EU Single Assessment of substances contained in both Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs) to the European Medicines Agency has been published on the eSubmission Gateway and Web Client page.
Both eCTD and NeeS validation criteria will be mandatory from 1 September 2013. During a transition period from 1 July to 1 September 2013, the new validation criteria should only be used for validation of eCTD/NeeS submissions built in accordance with the EU M1 specification v2.0. After 1 September 2013, only submissions compliant with the new validation criteria are accepted (v.5.0 for eCTD and v.4.0 for NeeS). Please refer to the Implementation Guide on the TIGes webpage for the EU module 1, when published.
The EU Module 1 specification v.2.0, updated DTD and the release notes have now been published. The EU Module 1 v2.0 enables marketing authorisation application in Croatia and can be used from 1 July 2013. A six month period is foreseen from publication of this guidance to upgrade systems that build, validate and review eCTD. It is anticipated that EU Module 1 v2.0 will be required by EMA and National Competent Authorities from 1 September 2013, but precise guidance on transition will be published in due course. Guidance on how to submit information relevant to Croatia from 1 July using EU Module 1 v1.4.1 will be published shortly.
The European Medicines Agency’s Gateway Release II and the eSubmission Web Client are now live for all applications for Centralised Procedure marketing authorisations for human medicines and can be found here
A subteam of the TIGes group is working on revisions to the Module 1 specifications and a number of related documents. This effort is driven by the expected accession of Croatia to the European Union in July 2013. Thus the DTD must provide for this country to be included in a centralised procedure submission in eCTD format. The team working on the revisions are taking the opportunity to address a number of other pending change requests that effect the Module 1 specification and/or DTD and related documents. For your information, the pending change requests to be addressed are listed in a streamlined tracking table found here. Please note that any change requests received by 31 December 2012 will be considered for inclusion in the revisions the team has undertaken. The form to submit change requests can be found here. Change Requests should be submitted to email@example.com