Veterinary Medicines Regulation

Key benefits of the Regulation
EMA role in implementing the Regulation
Implementing the Union Product Database
Progress updates
EMA recommendations on delegated and implementing acts

The Veterinary Medicines Regulation (Regulation (EU) 2019/6) will modernise the existing rules on the authorisation and use of veterinary medicines in the European Union (EU) when it becomes applicable on 28 January 2022. It contains new measures for increasing the availability and safety of veterinary medicines and enhances EU action against antimicrobial resistance. The European Medicines Agency (EMA) is working closely with the European Commission and other EU partners in preparation for the implementation of the Regulation.

The main objectives of the Regulation are to:

simplify the regulatory environment and reduce administrative burden for pharmaceutical companies developing veterinary medicines, for example through streamlined pharmacovigilance rules;
stimulate the development of innovative veterinary medicines, including products for small markets (minor use and minor species);
improve the functioning of the internal market for veterinary medicines;
strengthen EU action to fight antimicrobial resistance through specific measures ensuring prudent and responsible use of antimicrobials in animals, including reserving certain antimicrobials for the treatment of infections in people.

Regulation (EU) 2019/6 repeals Directive 2001/82/EC and amends the provisions of Regulation (EU) 726/2004 relating to the authorisation and supervision of veterinary medicines, which currently governs the centralised marketing authorisation procedure for both human and veterinary medicines.

The European Parliament and the European Council adopted Regulation (EU) 2019/6 in December 2018. It will become applicable on 28 January 2022.

Key benefits of the Regulation

Increased availability and access to safe and high-quality medicines for veterinarians, farmers and pet owners to treat and prevent animal diseases
Reduced administrative burden and better incentives for pharmaceutical companies developing new and innovative veterinary medicines, benefiting in particular micro, small and medium-sized enterprises (SMEs)
New and enhanced rules to keep antimicrobials (including antibiotics) effective based on a 'One health' approach for the benefit of animal and public heath and every EU citizen

EMA role in implementing the Regulation

EMA contributes to discussions on implementing and delegated acts, which the European Commission is preparing as part of the implementation of the Regulation. In particular, the Agency provides scientific and technical recommendations as and when requested by the European Commission.

EMA is also responsible for:

revising its procedures and regulatory and scientific guidance documents, in line with the Regulation and its implementing and delegated acts;
leading the implementation of Information technology (IT) systems required by the Regulation, including the Union Product Database, which will provide information on all authorised veterinary medicines and their availability in EU Member States;
implementing the outcomes of the implementing and delegated acts.

Implementing the Union Product Database

A draft implementation guide for the Union Product Database is available for public consultation.

It contains guidance for marketing authorisation holders and national competent authorities on the submission of data on veterinary medicines to the Union Product Database using standardised data formats and terminologies throughout the EU.

The different chapters of the guide explain the timelines, requirements, process, technical specification, data elements and associated business rules for submitting these data.

The UPD will draw on the four SPOR data management services for the centralised management of master data in the EU. For more information, seeSubstance, product, organisation and referential (SPOR) master data.

Stakeholders should send their comments to vetchange.programme@ema.europa.eu by 21 March 2021 using the form provided below. They should fill in a separate form for commenting on each chapter.

The access policy for the Union Product Database sets out the types of information different user groups will be allowed to access once the database becomes operational in January 2022.

The final access policy is available below together with the outcome of a public consultation.

List item

Union Product Database (UPD) Access Policy - Veterinary Medicinal Products - Policy no 0082 (PDF/414.13 KB)

Adopted

First published: 27/01/2021
Last updated: 02/02/2021
Legal effective date: 26/01/2021
EMA/198149/2020 Corr.

Progress updates

EMA’s newsletter, published every two months in 2021, provides an update on progress towards implementing the Regulation.

To subscribe, write to vetchange.programme@ema.europa.eu.

European Medicines Agency’s privacy statement for electronic newsletters

EMA recommendations on delegated and implementing acts

At the request of the European Commission, EMA is preparing scientific and technical recommendations to feed into delegated and implementing acts as part of the implementation of the Regulation.

Details on the European Commission's requests and EMA's recommendations are included below and are also available on the European Commission's website.

EMA's recommendations are prepared by ad hoc experts groups composed of members of the European network of experts and EMA staff, in collaboration with other EU bodies, where necessary.

EMA updates this page when new recommendations become available.

Marketing authorisation

European Commission request	Request for scientific recommendation for revising Annex II regarding the technical data to be provided by the applicants for marketing authorisations of veterinary medicinal products
Date of request	6 February 2019
EMA recommendation	Scientific recommendation on the revision of Annex II to Regulation (EU) 2019/6 on veterinary medicinal products
Summary of recommendation	The proposed revised Annex: updates the current technical requirements to demonstrate quality, safety and efficacy of veterinary medicines; introduces requirements for biological veterinary medicines other than immunologicals and novel therapies, with the aim of providing predictability for the development of new products and promoting innovation; addresses specific requirements for antimicrobial veterinary medicines with the aim of limiting the risk of development of antimicrobial resistance. EMA may need to provide further guidance on specific topics to complement the recommendation. This may result in the revision of existing or development of new scientific guidelines.
Date of recommendation sent to the European Commission	30 August 2019

European Commission request	Request for scientific recommendation on the list of variations not requiring assessment
Date of request	6 February 2019
EMA recommendation	Scientific recommendation on the list of variations not requiring assessment
Summary of recommendation	EMA has proposed a list of variations that do not require assessment, classifying 25% of chemical and 19.7% of biological current type IB variations as not requiring scientific assessment. Additionally, in total, 51.3% of all applicable variations for chemicals have been classified as not requiring assessment compared to 46.5% type IA/IAIN notifications in the current system. For biologicals, 47.5% of all applicable variations have been classified as not requiring assessment compared to 43.1% type IA/IAIN notifications in the current system. The reduction in the number of variations to be assessed will lead to an overall reduction of burden when processing variations.
Date of recommendation sent to the European Commission	30 August 2019

Union Product Database

European Commission request	Request for recommendations on the Union Product Database and the technical and functional analysis necessary for its establishment
Date of request	27 February 2019
EMA recommendation	Recommendations on the Union Product Database and the technical and functional analysis necessary for its establishment
Summary of recommendation	The recommendation outlines: a high-level overview of business requirements and non-functional requirements; related business processes and use case models; the proposed architecture and data model; required data fields, interrelations with other IT systems and contingency arrangements.
Date of recommendation sent to the European Commission	30 August 2019

Antimicrobial sales and use

European Commission request	Request for scientific recommendation on specific requirements for the collection of data on antimicrobial medicines used in animals
Date of request	6 February 2019
EMA recommendation	Report on specific requirements for the collection of data on antimicrobial medicinal products used in animals
Summary of recommendation	EMA's recommendations cover the: types of antimicrobial medicinal products used in animals, for which sales and use data are to be collected; general quality assurance requirements to be put in place by Member States and EMA to ensure quality and comparability of data; general rules on the methods of gathering these data and of their transfer to EMA.
Date of recommendation sent to the European Commission	30 August 2019

European Commission request	Request for recommendations on the format for the collection of data on antimicrobial medicinal products used in animals
Date of request	1 July 2019
EMA scientific recommendation	Advice on implementing measures under Article 57(4) of Regulation (EU) 2019/6 on veterinary medicinal products - Report on the format of the data to be collected on antimicrobial medicinal products used in animals
Summary of recommendation	EMA’s recommendations include: format of data on sales of veterinary antimicrobial medicinal products and on use of veterinary and human antimicrobial medicinal products by animal species; format of additional information of importance for data validation; online data submission tools; format of animal population data.
Date of recommendation sent to the European Commission	30 June 2020

European Commission request	Request for recommendations on the establishment of the criteria for the designation of antimicrobials to be reserved for treatment of certain infections in humans in order to preserve the efficacy of those antimicrobials
Date of request	6 February 2019
EMA recommendation	Advice on implementing measures under Article 37(4) of Regulation (EU) 2019/6 on veterinary medicinal products – Criteria for the designation of antimicrobials to be reserved for treatment of certain infections in humans
Summary of recommendation	EMA's recommendations cover the: “Antimicrobials or classes of antimicrobials designated to be only used in humans will be those that are of - highest importance to human health - for which the risk the transfer of resistance from animals to humans is considered as significant and for which the importance to animal health is low.”
Date of recommendation sent to the European Commission	31 October 2019

European Commission request	Request for scientific recommendations on the content of list of antimicrobials to be reserved for human medicine
Date of request	1 July 2019
Open call for data on the use of antimicrobials in animals	Open call for data on use of antimicrobials in animals Use this questionnaire to submit information.
EMA recommendation	Postponed until publication of the Delegated Act establishing the criteria for designating antimicrobials reserved for human use.
Summary of recommendation
Date of recommendation sent to the European Commission

European Commission request	Implementing measures under Article 107(6) of Regulation (EU) 2019/6 on veterinary medicinal products, regarding the establishment of a list of antimicrobials, which shall not be used in accordance with Articles 112, 113 and 114 or which may be used in accordance with these articles subject to certain conditions
Date of request	17 February 2020
EMA recommendation	Expected after adoption at the February 2021 meeting of the CVMP
Summary of recommendation
Date of recommendation sent to the European Commission

Pharmacovigilance

European Commission request	Request for recommendations on implementing measures on veterinary medicinal products regarding good pharmacovigilance practice
Date of request	6 February 2019
Summary of EMA recommendation	Report on veterinary medicinal products regarding good pharmacovigilance practice
Summary of recommendation	The recommendations for good veterinary pharmacovigilance practice set out in this advice: update the requirements for adverse event recording and reporting; establish data provisions for calculation of the incidence of reported adverse events; establish requirements for signal management based on the signal detection as the principle pharmacovigilance pillar; introduces requirements for pharmacovigilance communication; and updates the requirements for pharmacovigilance inspections; with the aim of reducing administrative burden while guaranteeing a high level of protection to public and animal health and the environment. The Agency will provide further guidance to complement the recommendations which will require revision and development of new scientific guidelines.
Date of recommendation sent to the European Commission	29 May 2020

European Commission request	Request for scientific recommendations on the format and content of the pharmacovigilance system master file and its summary
Date of request	6 February 2019
EMA recommendation	Report on veterinary medicinal products regarding the pharmacovigilance system master file
Summary of recommendation	The pharmacovigilance system master file is introduced in the veterinary sector for the first time. It is intended to be a detailed description of the pharmacovigilance system of the marketing authorisation holder with respect to one or more of its authorised veterinary medicinal products. The recommendations cover: General requirements for the pharmacovigilance system master file; Content of the main part of the pharmacovigilance system master file; Content of the annexes to the pharmacovigilance system master file; Format and maintenance of the pharmacovigilance system master file; The location and availability of the pharmacovigilance system master file; Content of the summary of the pharmacovigilance system master file to be submitted as part of the marketing authorisation application; EMA may need to provide further guidance on specific topics to complement the recommendation. This may result in the revision of existing or development of new scientific guidelines.
Date of recommendation sent to the European Commission	29 May 2020

Good distribution practice (GDP)

European Commission request	Request for scientific recommendations on measures on good distribution practice for veterinary medicinal products
Date of request	1 July 2019
EMA recommendation	Advice on implementing measures under Article 99(6) of Regulation (EU) 2019/6 on veterinary medicinal products - Good distribution practices (GDP) for veterinary medicinal products
Summary of recommendation	EMA’s recommendations include: good practices for distribution of veterinary medicinal products; alignment with existing GDP rules in the EU for the human sector and international guidance.
Date of recommendation sent to the European Commission	30 June 2020

European Commission request	Request for recommendations on good distribution practice for active substances used as starting material in veterinary medicines (Article 95 (8))
Date of request	1 July 2019
EMA recommendation	Advice on implementing measures under Article 95(8) of Regulation (EU) 2019/6 on veterinary medicinal products - Good distribution practices (GDP) for active substances used as starting materials in veterinary medicinal products
Summary of recommendation	EMA’s recommendations include: good practices for distribution of active substances for use in veterinary medicines; alignment with existing GDP rules in the EU for the human sector and international guidance.
Date of recommendation sent to the European Commission	30 June 2020

Oral routes of administration

European Commission request	Request for recommendations on the rules on appropriate measures to ensure the effective and safe use of veterinary medicines authorised and prescribed for oral administration via routes other than medicated feed
Date of request	2 July 2019
EMA recommendation	Scientific problem analysis and recommendations to ensure a safe and efficient administration of oral veterinary medicinal products via routes other than medicated feed
Summary of recommendation	EMA’s recommendations include: certain restrictions for in-feed use of oral veterinary medicines to individual animals only, and ensuring the availability of appropriate pack sizes; providing better information and training for people administering the medicines, including clear instructions in the product information on how to administer and dispose of the medicines and clean the equipment, and developing a good practice guide for farmers; measures to minimise antimicrobial resistance and environmental exposure, including restricting the prescription of oral antimicrobials to a single medicine in food-producing animals.
Date of recommendation sent to the European Commission	31 August 2020

Veterinary Medicines Regulation

Table of contents

Key benefits of the Regulation

EMA role in implementing the Regulation

Implementing the Union Product Database

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database (PDF/239.24 KB)

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 1: Registration and data access requirements for the User Interface (UI) and Application Programming Interface (API) (PDF/225.65 KB)

EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information (PDF/1.47 MB)

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 3: Process for the initial submission and maintenance of veterinary medicinal products information (PDF/259.66 KB)

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 4: Process and format for the submission of legacy data on veterinary medicinal products (PDF/560.28 KB)

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 5: Technical specifications (PDF/213.63 KB)

Template for the submission of comments on the EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database (DOCX/114.5 KB)

Union Product Database (UPD) Access Policy - Veterinary Medicinal Products - Policy no 0082 (PDF/414.13 KB)

Draft Union Product Database (UPD) Access Policy - Veterinary Medicinal Products - Policy no 0082 (PDF/154.65 KB)

Union Product Database (UPD) Access Policy - Veterinary Medicinal Products - Policy no 0082 - Overview of comments (PDF/302.84 KB)

Progress updates