Updated on 3 April 2025:
Essential substances for equine species
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 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
Essential substances for equine species
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 | |
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Date of request | 9 February 2023 | |
EMA recommendation | Scientific advice under Article 115(5) of Regulation (EU) 2019/6 on veterinary medicinal products, regarding the list of substances essential for the treatment of equine species and for which the withdrawal period for equine species shall be six months | |
Summary of recommendation | The EMA's recommendation covers the:
The recommendation includes, in section 6 of the advice, the list of substances which are considered essential for the treatment of equine species, presented along with their aimed indication, explanation of use, and identification of alternatives. | |
Date of recommendation sent to the European Commission | 19 July 2024 | |
Background to the addendum | Background to the addendum to the scientific advice under Article 115(5) of Regulation (EU) 2019/6 on veterinary medicinal products | |
Addendum to EMA recommendation | Addendum to the scientific advice under Article 115(5) of Regulation (EU) 2019/6 on veterinary medicinal products |
Marketing authorisation
European Commission request | Annex II to Regulation (EU) 2019/6 on veterinary medicinal products |
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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:
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 | 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
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:
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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
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:
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:
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)
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:
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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 |
Good Manufacturing Practice (GMP)
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 |
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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
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:
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Date of recommendation sent to the European Commission | 31 August 2020 |