An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update will introduce an additional business rule to help users to select correctly PASS 107 procedures types. Also, Purchase Order number attribute for PASS 107 procedure was introduced.
eSubmission CMB and CMB documents have been renamed eSubmission expert group and eSubmission expert group documents. The eSubmission CMB changed its name in June 2018 to better reflect its current status and tasks.
The document “Exceptions to the VNeeS format” has been updated. Please see the link in the section “Current Guidance” on the Veterinary eSubmission page.
The ICH M9 Biopharmaceutics Classification System-based Biowaivers reached Step 2b of the ICH Process in June 2018 and now enters the consultation period.
The MedDRA Management Committee noted significant achievements in supporting the global expansion of MedDRA use
The International Council for Harmonisation (ICH) met in Kobe, Japan on 2 – 7 June 2018.
The Common Repository has been extended to include all human Referral submissions from 1st September 2017. The use of the Common Repository for human Referral submissions will become mandatory for all NCAs on 1st of December 2017. There should be no referral submissions directly to any NCAs from 1st of December 2017 as these will [...]
The use of the Common Repository by National Competent Authorities (NCAs) to retrieve veterinary submissions is now mandatory since the 1st of June 2018. Please see further details in the Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency and to members of the Committee for [...]
The ICH Q3D(R1) Revision of the ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in May 2018 and now enters the consultation period.
Version 1.23 of the electronic Application Forms (eAFs) will become available on 13 July 2018. The release v1.23 will provide further integration with OMS from SPOR (Organisational/address data) and NTA changes. User Acceptance Testing (UAT) is planned to support the release of this next version of the forms