05 June 2013

EMA: Implementation guide for EU Module 1 Specification, version 2.0 released

The Implementation guide for EU Module 1 Specification, version 2.0 and EU eCTD Validation Criteria, version 5.0 and EU NeeS Validation Criteria, version 4.0 has been published by the EU Telematics Implementation Group - electronic submissions (TIGes).

According to this implementation guide the new EU Validation Criteria for eCTD and NeeS will come into force on 01 September 2013 and will be used for the technical validation for all incoming electronic submissions by National Regulatory Agencies and the EMA. As a consequence, the corresponding earlier versions of the EU Validation Criteria will be withdrawn on 31 August 2013.

Regarding the new EU Module 1 that has been published in 01 March 2013 a transition period for will be established:

  1. Starting from 01 July 2013 applicants can submit either eCTDs compliant with EU Module v. 1.4.1 (applying eCTD validation criteria 4.1) or EU Module v. 2.0 (applying eCTD validation criteria 5.0)
  2. From 01 September 2013 only eCTDs compliant with EU Module 1 v. 2.0 will be accepted.

For NeeS submission the timelines and transitional arrangements are applicable likewise. For NeeS, EU validation criteria 4.0 must be used from 01 September 2013 on.

Guidance on how to submit information relevant to Croatia:

If there is a need to provide information relevant to Croatia prior to 01 September 2013 and EU Module 1 v. 2.0 cannot be used, it is acceptable to submit the corresponding information for Croatia in the "<sequence>-workingdocuments" folder accompanying the eCTD. A respective subfolder "hr" should be used. A corresponding note should be included in the cover letter. This approach is also applicable for Centralized Procedures.
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