Application guidance (veterinary medicines)

The European Medicines Agency provides guidance documents to companies and individuals involved in developing and marketing veterinary medicines in the European Union. These include guidance on dossier requirements, submission dates, procedures as well as templates and checklists for applications.

The use of electronic Application Forms (eAF) is mandatory for all application procedures (authorisations and variations requiring assessment). 

It is also mandatory for applicants to use the eSubmission Gateway / Web Client for all veterinary procedural submissions to the Agency.

For more information, including links to guidance on registration with the system, see:

• Veterinary eSubmission website

Dossier requirements and recommended submission dates

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)

Reference Number: EMA/466102/2007 Rev. 34Summary:

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)

Recommended submission dates for veterinary medicinal products

AdoptedReference Number: EMA/541149/2023 Rev.3

• Information on summary of product characteristics requirements can be found in the veterinary Product information requirements page - Quality review of documents (QRD) section.

Guidance

Procedural advice on the accelerated assessment of marketing authorisation applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6

Reference Number: EMA/CVMP/32995/2006 Rev. 2

Change of applicant - Cover letter standard text (veterinary)

Change of applicant checklist - pre-submission guidance (veterinary)

Reference Number: EMA/603587/2018

Guidance to applicants / marketing authorisation holders on oral explanations at CVMP

Reference Number: EMA/CVMP/519444/2016

Validation checklist for initial marketing authorisation applications - biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6)

Reference Number: EMA/278419/2022 Rev.1

Validation checklist for initial marketing authorisation applications – immunologicals (applicable to submissions under Regulation (EU) 2019/6)

Reference Number: EMA/377884/2015 Rev. 2

Validation checklist for initial marketing authorisation applications – pharmaceuticals (applicable to submissions under Regulation (EU) 2019/6)

Reference Number: EMA/377885/2015 Rev. 2

Summary of procedures for consultation by the Committee for Medicinal Products for Veterinary Use of scientific advisory groups (SAGs) and ad-hoc expert groups functioning as SAGs in relation to applications for authoris...

AdoptedReference Number: EMA/347137/2010

Guideline on the acceptability of names for veterinary medicinal products processed through the centralised procedure

AdoptedReference Number: EMEA/CVMP/328/98 Rev. 3

The checking process of mock-ups and specimens of outer/immediate labelling and package leaflets in the centralised procedure for veterinary medicinal products

AdoptedReference Number: EMA/14522/2007 Rev.3