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 expertsEuropean 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, see Veterinary Medicines Regulation.

Substances for aquatic species

List of substances used in veterinary medicinal products authorised in the Union which may be used in food-producing aquatic species in accordance with Article 114(1)

European Commission request	Implementing measures under Article 114(3) of Regulation (EU) 2019/6 as regards substances used in veterinary medicinal products authorised in the Union which may be used in food-producing aquatic species in accordance with Article 114(1)
Date of request	12 April 2023

Essential substances for equine species

List of substances which are essential for the treatment of equine species, or which bring added clinical benefit compared to other treatment options available for equine species and for which the withdrawal period for equine species shall be six months

European Commission request	Implementing measures under Article Art 115(5) of Regulation (EU) 2019/6 as regards the list of substances which are essential for the treatment of equine species and for which the withdrawal period for equine species shall be six months
Date of request	9 February 2023

Marketing authorisation

Technical data to be provided by marketing authorisation applicants (Annex II)

European Commission request	Annex II to Regulation (EU) 2019/6 on veterinary medicinal products
Date of request	6 February 2019
EMA recommendation	Advice implementing measures under Article 146(2) of Regulation (EU) 2019/6 on veterinary medicinal products – 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
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

Variations not requiring assessment

European Commission request	List of variations not requiring assessment
Date of request	6 February 2019
EMA recommendation	Advice on implementing measures under Article 60(1) of Regulation (EU) 2019/6 on veterinary medicinal products - 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

Union Product Database

Technical and functional specifications for the 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	Advice to the European Commission on the Union Product Database
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

Antimicrobial sales and use

Requirements for the collection of data on antimicrobials used in animals

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	Advice on implementing measures under Article 57(3) of Regulation (EU) 2019/6 on veterinary medicinal products - 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

Format for the collection of data on antimicrobials used in animals

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
Adopted implementing regulation	Commission Implementing Regulation (EU) 2022/209 of 16 February 2022 establishing the format of the data to be collected and reported in order to determine the volume of sales and the use of antimicrobial medicinal products in animals in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council
Date of adoption	16 February 2022

Criteria for antimicrobials to be reserved for human use

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
Adopted Delegated Regulation	Commission Delegated Regulation (EU) 2021/1760 of 26 May 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council by establishing the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans
Date of adoption	26 May 2021

List of antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans (updated)

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	Advice on the designation of antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans - in relation to implementing measures under Article 37(5) of Regulation (EU) 2019/6 on veterinary medicinal products
Summary of recommendation	A compiled recommendation for the groups of antimicrobials to be reserved for treatment of humans only (Article 37(5)) is presented in Table 1 in the Summary of the advice. The Summary also includes further recommendations based on considerations of the Agency that developed from the scientific review process.
Date of recommendation sent to the European Commission	28 February 2022
Adopted implementing regulation	Commission Implementing Regulation (EU) 2022/1255 of 19 July 2022 designating antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans, in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council
Date of adoption	19 July 2022

List of antimicrobials, which shall not be used in accordance with Articles 112-114 or which may be used in accordance with these articles subject to certain conditions (Article 107(6))

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 [...]
Date of request	17 February 2020
EMA recommendation	Scientific advice under Art.107(6) of Reg.(EU)2019/6 for establishment of a list of antimicrobials which shall not be used in accordance with Art. 112, 113 and 114 or which shall only be used in accordance with these articles subject to certain conditions
Summary of recommendation	The EMA’s recommendations address: Antimicrobials which it is proposed should not be used in accordance with Articles 112, 113 and 114 (Table (a)). Antimicrobials which it is proposed should only be used in accordance with Articles 112, 113 and 114 subject to certain conditions. The recommended conditions for use of each of these antimicrobial classes are included in Table (b).
Date of recommendation sent to the European Commission	16 June 2023

Pharmacovigilance

Good pharmacovigilance practice

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

Format and content of the pharmacovigilance system master file and its summary

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
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

Good Distribution Practice (GDP)

GDP for veterinary medicines

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

GDP for active substances used as starting material in veterinary medicines (Article 95 (8))

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
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

Good Manufacturing Practice (GMP)

GMP for veterinary medicines and active substances

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	Advice on the implementing measures under Article 93(2) of Regulation (EU) 2019/6 of the European Parliament and of the Council on Veterinary Medicinal Products, as regards the GMP for veterinary medicinal products and active substances used as starting materials
Summary of recommendation	In addition to recommendations for GMP for veterinary medicinal products and for veterinary active substances, the advice also proposes that GMP requirements are applied to the manufacture of autogenous vaccines and novel therapy veterinary medicinal products, which are currently not subject to such requirements. The advice proposal also covers GMP measures that guarantee the highest level of environmental protection and take into account animal welfare standards.
Date of recommendation sent to the European Commission	15 December 2023

Oral routes of administration

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

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	Advice on implementing measures under Article 106 (6) of Regulation (EU) 2019/6 on veterinary medicinal products – scientific problem analysis and recommendations to ensure a safe and efficient administration of oral veterinary medicinal products via rout
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