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 [...]
Mock-ups, Specimens and Samples for variations (May 2024) [Track version]
Mock-ups, Specimens and Samples for new applications (December 2020) [Track version]
Template - Preliminary Renewal Assessment Report (February 2025) [Track version]
Pharmacovigilance Legislation [Track version] (December 2020, correction March 2024)
Practical guidance on the implementation of the Protocol on Ireland/Northern Ireland for medicinal products for human use approved via MRP/DCP (May 2022) [Track version]
The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.4 reached Step 4 of the ICH process in December 2020.