Scientific and technical recommendations: Veterinary Medicines Regulation
The European Medicines Agency (EMA) is preparing scientific and technical recommendations to feed into delegated and implementing acts as part of the implementation of the Veterinary Medicines Regulation (Regulation (EU) 2019/6). EMA is providing these recommendations at the request of the European Commission.
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.
For more information on implementation of the Regulation, seeVeterinary Medicinal Products Regulation.
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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 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 Adopted Delegated Regulation Commission Delegated Regulation (EU) 2021/805 of 8 March 2021 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance) Date of adoption 8 March 2021 -
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 Adopted Implementing Regulation Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance) Date of adoption 8 January 2021
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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 Adopted Implementing Regulation Commission Implementing Regulation (EU) 2021/16 of 8 January 2021 laying down the necessary measures and practical arrangements for the union database on veterinary medicinal products (Union product database) Date of adoption 8 January 2021
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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 Adopted delegated Regulation Commission Delegated Regulation (EU) 2021/578 of 29 January 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council with regard to requirements for the collection of data on the volume of sales and on the use of antimicrobial medicinal products in animals Date of adoption 29 January 2021 -
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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 Summary of recommendation Date of recommendation sent to the European Commission
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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 Adopted Implementing Regulation Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 laying down rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products Date of adoption 2 August 2021 -
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;
Date of recommendation sent to the European Commission 29 May 2020 Adopted Implementing Regulation Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 laying down rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products (adopted on 02/08/2021) Date of adoption 2 August 2021
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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 Adopted Implementing Regulation Commission implementing regulation (EU) 2021/1248 of 29 July 2021 as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (adopted on 29/07/2021) Date of adoption 29 July 2021 -
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 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 Adopted Implementing Regulation Commission Implementing Regulation (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (adopted on 02/08/2021) Date of adoption 2 August 2021
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European Commission request
Implementing measures under Article 93(2) of Regulation (EU) 2019/6 as regards the good manufacturing practice for veterinary medicinal products and active substances used as starting materials
Date of request 27 July 2022 EMA recommendation Summary of recommendation Date of recommendation sent to the European Commission
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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