Variations Requiring Assessment (Veterinary Medicines) - Q&A Update

Key changes

Addition of Question 23 to the procedural Q&A regarding variations for veterinary products.

PV impact

Minor procedural update for veterinary MAH regulatory teams handling variations.

Exact policy details

Submission of variations

Centrally authorised veterinary medicines require assessment under Regulation (EU) 2019/6.

Applies to: Applies to all marketing authorisation holders submitting variations for centrally authorised veterinary medicines.

This page provides guidance on how to apply for a variation on centrally authorised veterinary medicines requiring assessment under the Veterinary Medicinal Products Regulation. · p. 1 · High · Source

Electronic submission

Mandatory submission via the EMA e-Submission Gateway or Syncplicity Web Client.

Applies to: All submissions to the EMA related to applications for central marketing authorisation.

Electronic submission via the EMA e-Submission Gateway or Syncplicity Web Client is mandatory. · p. 1 · High · Source

Worksharing procedures

Complete dossier must be submitted via Gateway/Syncplicity Web Client for each centrally authorised product.

Applies to: Applies to worksharing procedures for centrally authorized products and nationally authorized products.

For worksharing procedures, the complete dossier should be submitted via the Gateway/Syncplicity Web Client for each centrally authorised product included in the worksharing procedure. · p. 2 · High · Source

Extracted documents

• Variations requiring assessment (veterinary medicines) | European Medicines Agency (EMA)htmlhtml · high · 1 page
• QRD Form 2 and checklist for the submission of day +25 files - veterinarydocxdocx · high · 1 page
• Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency (EMA) and to members of the Committee for Medicinal Products for Veterinary use (CVMP)pdfpdf_text · high · 5 pages
• Guidance to applicants / marketing authorisation holders on oral explanations at CVMPpdfpdf_text · high · 3 pages