An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced changes to the delivery file (addition of 'nitrosamine related' radio button for initial variation submissions (human domain only) and renaming the 'Customer Reference' field to 'purchase order number' for all relevant submission types and submission units [...]
Lead Member State PSUR Follow-Up assessment report (February 2025) [Track version]
An updated version of the eSubmission Gateway XML delivery file user interface for veterinary MRL and referral submissions is now available. This update has introduced changes to the delivery file (changes in the available submission units and mandatory use of customer number and Purchase Order number).
An updated version of the eSubmission Gateway XML delivery file user interface for veterinary MRL and referral submissions is planned for release in the evening of 8th March 2021. This update will introduce changes to the delivery file (changes in the available submission units and mandatory use of customer number and Purchase Order number). Users [...]
An updated version of the eSubmission Gateway XML delivery file user interface is planned for release in the evening of 11th March 2021. This update will introduce changes to the delivery file (addition of ‘nitrosamine relate' radio button for initial variation submissions and renaming the 'Customer Reference' field to PO number for all relevant submission [...]
Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products Appendix 1: Acceptable intakes established for N-nitrosamines Appendix 2 : Carcinogenic Potency Categorisation Approach for N-nitrosamines Appendix 3 : Enhanced Ames Test Conditions for N-nitrosamines
The Guideline on eSubmissions for Veterinary products has been updated to version 2.7.1, applicable immediately. This minor change is Brexit related change in the list of country codes in table 4. This change has no impact on the validation rules and the current VNeeS Checker tool (v2.6) remains unchanged.
2020 - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
The Guideline on eSubmissions for Veterinary products has been updated to version 2.7.1, applicable immediately. This minor change is Brexit related change in the list of country codes in table 4. This change has no impact on the validation rules and the current VNeeS Checker tool (v2.6) remains unchanged.
It is now mandatory to use the version 1.24.0.1 of all four eAFs. The term United Kingdom has been removed from the EU/EEA country grouping on 1st of January 2021 for selection in any version of the forms (in the fields where EU/EEA countries are listed). Applicants are reminded that the version of the form [...]