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Abstract This article focuses on the new Veterinary Medicines Regulation, which is applicable across all Member States of the European Union, including Ireland, from 28 January 2022. From this date, prophylactic use of antimicrobials (AMs) in groups of animals is banned, metaphylactic use in groups of animals is restricted, and certain AMs are reserved for humans only. In the Irish dairy industry, as elsewhere, successful implementation of the Regulation will require a high level of mastitis control across all herds, and measures to support high standards in antibiotic stewardship. National actions will be critical, to support optimal mastitis control throughout the national herd. For private veterinary practitioners (PVPs), the Regulation will lead to specific prescribing changes, including the requirement to shift from blanket to selective dry cow therapy. Further, prescribing choices will need to be guided by the categorisation for AMs developed by the European Medicines Agency (EMA). More broadly, the Regulation requires a fundamental shift in thinking both in terms of AM usage and of the role of the PVP. Given the close association between mastitis control and intramammary AM stewardship, it is imperative that prescribing and mastitis control decisions are made concurrently. A herd health approach will be critical, within a Client-Patient-Practice Relationship as outlined by the Veterinary Council of Ireland. On those farms with sub-optimal mastitis control, mastitis issues need to be sustainably resolved. A detailed farm investigation by the PVP, in partnership with the farmer and other milk quality professionals, is essential, to understand the epidemiology and on-farm drivers of mastitis, to develop farm-specific action plans, and to facilitate ongoing monitoring of progress. It is vital that PVPs provide leadership, with the provision of a holistic, herd health approach to inform both prescribing and mastitis control decisions in herds under their care.

This material is intended to convey the main elements of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11.12.2018 on veterinary medicinal products and repealing Directive 2001/82 / EC. The needs of the veterinary sector differ substantially from those of the human sector in terms of medicines. This U.E. lays down rules for: manufacture, placing on the market, import, export, making available, distribution, pharmacovigilance, control and use of veterinary medicinal products. The main issues covered were: sale: wholesale, retail and online, use of veterinary medicinal products, veterinary prescription and records, waiting period for a.u.v. products, advertising and controls in light of the new regulations.

This article focuses on the new Veterinary Medicines Regulation, which is applicable across all Member States of the European Union, including Ireland, from 28 January 2022. From this date, prophylactic use of antimicrobials (AMs) in groups of animals is banned, metaphylactic use in groups of animals is restricted, and certain AMs are reserved for humans only. In the Irish dairy industry, as elsewhere, successful implementation of the Regulation will require a high level of mastitis control across all herds, and measures to support high standards in antibiotic stewardship. National actions will be critical, to support optimal mastitis control throughout the national herd. For private veterinary practitioners (PVPs), the Regulation will lead to specific prescribing changes, including the requirement to shift from blanket to selective dry cow therapy. Further, prescribing choices will need to be guided by the categorisation for AMs developed by the European Medicines Agency (EMA). More broadly, the Regulation requires a fundamental shift in thinking both in terms of AM usage and of the role of the PVP. Given the close association between mastitis control and intramammary AM stewardship, it is imperative that prescribing and mastitis control decisions are made concurrently. A herd health approach will be critical, within a Client-Patient-Practice Relationship as outlined by the Veterinary Council of Ireland. On those farms with sub-optimal mastitis control, mastitis issues need to be sustainably resolved. A detailed farm investigation by the PVP, in partnership with the farmer and other milk quality professionals, is essential, to understand the epidemiology and on-farm drivers of mastitis, to develop farm-specific action plans, and to facilitate ongoing monitoring of progress. It is vital that PVPs provide leadership, with the provision of a holistic, herd health approach to inform both prescribing and mastitis control decisions in herds under their care. [ABSTRACT FROM AUTHOR]

The environmental risk assessment (ERA) of veterinary medicinal products (VMPs) has been a regulatory requirement in the European Union (EU) since 1993. However, in the last few years, the potential impact of human and veterinary medicines on the environment has become a growing concern worldwide. Indeed, the legal requirements for VMPs in the EU are changing. Regulation (EU) 2019/6, which will be applied from January 28, 2022, aims to update the regulatory framework for VMPs and replaces Directive 2001/82/EC. This paper analyzes the ability of both legislations to ensure a high level of protection of the environment while authorizing VMPs. Consideration is also given to the impact on administrative burdens in both the legislations. We conclude that the Regulation improves the Directive by reducing to a certain extent the regulatory burdens for the applicants and authorities. However, the knowledge of the environmental risks of all authorized VMPs and the consistency of the assessments remain quite similar between both legislations. Nevertheless, the new Regulation proposes to examine the feasibility and applicability of an assessment system based on the critical review of properties of the active substances ("monographs") or other potential alternatives. With this in mind, two proposals (a basic and an enhanced approach) for developing a monograph system are presented and their main advantages and disadvantages are explored. Integr Environ Assess Manag 2021;17:1274–1285. © 2021 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC) KEY POINTS: The environmental risk assessment (ERA) of veterinary medicinal products (VMPs) performed according to the Directive 2001/82/EC does not allow the systematic review of the environmental risks of all the VMPs authorized and supposes a lack of harmonization among equal active substances.The forthcoming legislation (Regulation [EU] 2019/6) improves the Directive in terms of ERA. However, the issues related to the lack of information on the environmental risks of all the VMPs in the market and the issues related to consistency remain.Article 156 of the Regulation gives the opportunity to study the feasibility of an active substance‐based review system (the so‐called "monographs") or other potential alternatives for the environmental risk assessment of VMPs.The development of a monograph system could be a good opportunity to solve the shortcomings detected in the ERA of VMPs of the current and forthcoming legislation. [ABSTRACT FROM AUTHOR]

This material is intended to convey the main elements of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11.12.2018 on veterinary medicinal products and repealing Directive 2001/82 / EC. The needs of the veterinary sector differ substantially from those of the human sector in terms of medicines. This U.E. lays down rules for: manufacture, placing on the market, import, export, making available, distribution, pharmacovigilance, control and use of veterinary medicinal products. The main issues covered were: sale: wholesale, retail and online, use of veterinary medicinal products, veterinary prescription and records, waiting period for a.u.v. products, advertising and controls in light of the new regulations. [ABSTRACT FROM AUTHOR]