Guidance documents

This page lists the European Medicines Agency's general guidance documents relating to veterinary medicines

If you have comments on a document that is open for consultation, use the and send it to [e-mail].

 

General

• Guidance for the application of Article 34 of Regulation (EU) 2019/6 - prescription status

Reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations

Consultation dates: 24/11/2022 to 28/02/2023Draft: consultation closedReference Number: EMA/CVMP/64911/2021

Concept paper for the development of a reflection paper on criteria for the application of Article 40(5) of Regulation (EU) 2019/6

Consultation dates: 20/07/2020 to 21/09/2020Draft: consultation closedReference Number: EMA/CVMP/340959/2020

Questions and answers on mentioning solvents in the product information of veterinary medicinal products authorised via the centralised procedure

Consultation dates: 18/12/2015 to 31/03/2016AdoptedReference Number: EMA/CVMP/550607/2015Summary:

This general guidance, in the form of a question and answer document, is intended to clarify how the product information (Summary of Product Characteristics (SPC), labelling and package leaflet) should be prepared for products which require solvents for their administration.

Concept paper on a revision of the guideline for an assessor preparing assessment reports

Consultation dates: 01/10/2009 to 31/12/2009Draft: consultation closedReference Number: EMEA/CVMP/626480/2009

Procedural advice on appointment and responsibilities of the CVMP rapporteur and co-rapporteur in accordance with Article 140(6) of Regulation (EU) 2019/6, and peer reviewer

AdoptedLegal effective date: 23/09/2009Reference Number: EMA/CVMP/468877/2009 - Rev. 3

Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework

AdoptedLegal effective date: 01/09/2005Reference Number: EMEA/P/24143/2004 Rev. 1 corr

Procedure to be followed to facilitate communication and dialogue between the CVMP and the interested parties

AdoptedLegal effective date: 18/10/2004Reference Number: EMEA/CVMP/329/04-Rev.1

Procedures for re-examination

Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions (according to Regulation (EU) 2019/6)

Reference Number: EMA/CVMP/321528/2017 Rev. 3Summary:

Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions

Publication of withdrawals

Reflection paper on publication of withdrawals of marketing authorisation applications for veterinary medicinal products

AdoptedReference Number: EMEA/CVMP/425558/2006-Rev.1

Overview of comments received on reflection paper on publication of withdrawals of marketing authorisation applications for veterinary medicinal products

Reference Number: EMEA/CVMP/247808/2007

Publication of refusals

Reflection paper on the publication of the CVMP’s negative opinion and refusal to recommend the granting of a marketing authorisation for veterinary medicinal products

AdoptedReference Number: EMEA/CVMP/459912/2006

Overview of comments received on reflection paper on publication of the CVMP’s negative opinion and refusal to recommend the granting of a marketing authorisation for veterinary medicinal products

Reference Number: EMEA/CVMP/247827/2007

Phasing-in of new legislation

Practical considerations on the impact of the new pharmaceutical legislation on marketing-authorisation applications via the centralised procedure and centrally authorised medicinal products for veterinary use

Reference Number: EMEA/316976/2005

• European Union GMP guide part II: Basic requirements for active substances used as starting materials: GMP compliance for active substances

Benefit-risk balance

• Criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation 2019/6
• Reflection paper on the application of Regulation (EU) 2019/6 for certain categories of variations
• Recommendation on the evaluation of the benefit-risk balance of veterinary medicinal products

CVMP reflection paper on the risks that should be considered prior to the use of unauthorised vaccines in emergency situations

AdoptedReference Number: EMA/CVMP/IWP/49593/2013Summary:

Due to the epidemiological situation of major infectious diseases in neighbouring European countries as well as worldwide, there is a continuous risk of outbreaks of new diseases, many of them exotic, in EU Countries. Depending on the level of emergency, the use of vaccines as one of the most effective methods to prevent and manage infectious diseases can be of crucial relevance for the control of outbreaks or the eradication of diseases in livestock animals.

Electronic submissions

Common Repository for all veterinary submissions in the centralised procedure – statement of intent

Reference Number: EMA/715059/2016

Overview of comments received on VICH guideline on electronic exchange of documents electronic file format (GL53)

Reference Number: VICH GL-53

Final VICH GL53: Electronic exchange of documents: electronic file format

AdoptedReference Number: EMA/CVMP/VICH/758781/2013 Corr. 1

Use of eSubmission Gateway / Web Client extended to new procedure types from 1st of April 2014

Reference Number: EMA/71358/2014Summary:

The EMA will extend the use of eSubmission Gateway and the Web Client to all Referral procedures, all

Veterinary Medicines submissions including Veterinary Referrals, and to Paediatric submissions such as

Paediatric investigation plans, waivers and modifications from 1st of April 2014.

Template - Framework for a correlation table (notice to applicants: Common Technical Document (CTD)) for active-substance master files / part 2 in CTD format for dossiers for veterinary medicinal products

Reference Number: EMA/115282/2012

As of 1 January 2017 it is 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:

• Procedural announcement on mandatory use of eSubmission Gateway for veterinary submissions as of 1 January 2017
• Veterinary eSubmission website
• eSubmission Gateway and Web Client information website

Accelerated assessment

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

Extended assessment

Procedural advice – extended assessment time for initial marketing authorisation applications of 90 days

Reference Number: EMA/CVMP/612534/2021