29-11-2013
Draft HMA eSubmission Roadmap
The draft HMA eSubmission roadmap (for consultation ) is available here
And
An eAF defects and workaround solutions document is available and can be found here
And
A new Common Repository is set to be launched in January 2014. For more information, click here
11-11-2013
TIGes Harmonised NeeS Guidance
The TIGes Harmonised NeeS guidance document version 4.0 can be found here and Release notes here
05-11-2013
The Slides from the EMA Gateway Webinar on the eSubmission of PSURs have been updated and can be viewed here
01-10-2013
The EU Change Request Tracking table has been updated and is available here
19-09-2013
Webinar on the use of the eSubmission Gateway
This recording of a recent webinar is aimed at all applicants submitting PSUR Single Assessment submissions in eCTD or NeeS format through the eSubmission Gateway and the Web Client. This session covers topics from registration and necessary configurations to the filename convention, and the receipts and acknowledgements the applicant will receive upon submission via the Gateway/Web Client. You can view the webinar by clicking here.
30-08-2013
New versions of the electronic application formsand release notes and schemas have been released and can be found here
And
The eCTD Validation Criteria has been updated, The TIGes Harmonised eCTD guidance version and Release notes have also been updated and can be found here
16-08-2013
Training sessions on the use of the eSubmission Gateway / Web Client for PSUR Single Assessment submissions
These training sessions are meant for all applicants submitting PSUR Single Assessment submissions in eCTD or NeeS format through the eSubmission Gateway and the Web Client. The sessions will cover topics from registration and necessary configurations to the filename convention and the receipts and acknowledgements that the applicant will receive upon submission via the Gateway/Web Client.
The places will be allocated on first come first served basis for up to 75 participants.
- Webinar: 27/09/2013 at 11.00 – 12:30 UK time
Book your place now by emailing natasha.brown@ext.ema.europa.eu
And
The slides from the eSubmission of PSUR slides via the EMA Gateway Webinar are available and can be found here
25-07-2013
New versions of the electronic application forms Renewal and Variations and Release Notes have been released and can be found here
23-07-2013
A new Q&A clarification document with regards to the eCTD validation criteria v5.0 ( mandatory from 1 September 2013) can be found here
15-07-2013
Information to Marketing Authorisation Holders on the use of updated Variations application form (human and veterinary)
Further to the publication of the European Commission Guidelines on Variations on 16/05/2013 and of the Variations application form (human and veterinary) on 04/072013, as part of EudraLex - Volumes 2C and 6C, Marketing Authorisation Holders are informed that the updated forms should be used for variations applications submitted to the Agency as of 04/08/2013.
The corresponding electronic variations application forms (eAF) will be made available by the Agency on the eSubmission page by 29/07/2013.
To allow MAHs and relevant stakeholders to prepare for the use of the eAF and, where applicable, prepare their organisation’s IT system interface upgrade, the data exchange standard (DES) is now available on the eAF page.
The availability of the updated Variations application form on 04/07/2013 and of the data exchange standard (DES) on 15/07/2013 allows MAHs and relevant stakeholders to familiarise themselves with the revised Variations application form, and to prepare for submission of variations using the updated form as of 04/08/2013.
References:
10-07-2013
Training sessions on the use of the eSubmission Gateway / Web Client for PSUR Single Assessment submissions
These training sessions are meant for all applicants submitting PSUR Single Assessment submissions in eCTD or NeeS format through the eSubmission Gateway and the Web Client. The sessions will cover topics from registration and necessary configurations to the filename convention and the receipts and acknowledgements that the applicant will receive upon submission via the Gateway/Web Client.
The places will be allocated on first come first served basis up to 95 participants per session.
- Webinar: 16/07/2013 at 15.00 – 16:30 UK time
- Webinar: 01/08/2013 at 9.30 – 11:00 UK time
Book your place now by emailing natasha.brown@ext.ema.europa.eu
19-06-2013
The Implementation guide for the EU Module 1 Specification, version 2.0, EU e CTD Validation Criteria, version 5.0 and EU NeeS Validation Criteria, version 4.0 has been revised and can be found here and on the TIGes webpage here
03-06-2013
The Implementation guide for the EU Module 1 Specification, version 2.0, EU eCTD Validation Criteria, version 5.0 and EU NeeS Validation Criteria, version 4.0 can be found here. This guidance includes information on submissions during the transitional period.
31-05-2013
The European Commission has published the revised version of the MAA-Human Form (revision 10.1 from April 2013) on 15 April 2013.
Notice to applicants, medicinal products for human use, volume 2B, module 1.2 administrative information application form. Applicants should use it starting Monday 3 June 2013.
The electronic version of this application form is now available for use and it can be found here.
24-05-2013
The EU Change Request Tracking table including EU eSubmission Q&A has been updated and is available here
22-05-2013
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 .
And
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.
19-03-2013
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.
01-03-2013
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.
15-01-2013
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
04-01-2013
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 esub.changerequests@ema.europa.eu
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