Read the online version | ISSN 2811-8707
  June 2024  

Veterinary Medicines Highlights

Quarterly news, activities and interviews from EMA Veterinary Medicines Division

EMA
banner for: Veterinary Medicines Highlights

Follow us EMA X | EMA Youtube | EMA LinkedIn

Editorial

Welcome to the 17th edition of the Veterinary Medicines newsletter. The Veterinary Antimicrobial Monitoring and Resistance Service is dedicated to supporting the objectives of Regulation (EU) 2019/6, promoting the responsible use of antimicrobials in animals.

Quote Among other challenges, the service coordinates the collection and analysis of data on the sales and use of antimicrobial medicinal products in animals. Such data help strengthen EU action against antimicrobial resistance in humans and animals under the ‘One Health’ approach.

The European Commission's 'One Health' approach to antimicrobial resistance addresses the human and veterinary sectors together in a holistic and coordinated manner. Contributing to this initiative, EMA, EFSA and ECDC published the 4th JIACRA report which presents data collected by the three agencies between 2019 and 2021. For the first time, this report includes a multi-agency analysis of trends in antimicrobial use and resistance in E. coli for both humans and animals.

We are continuously working with the EU regulatory network and other responsible authorities for the collection of antimicrobial sales and use data, ensuring that the ESVAC project legacy is carried forward in the new legislative obligations. By providing science-based evidence, policymakers are empowered to drive national strategies to limit or prevent the development of antimicrobial resistance.

In this context, significant collaborative efforts have been made by Member States and the Agency to improve the quality of the UPD product data that is used in the ASU Platform. This effort will be pivotal in ensuring that the data of this first reporting year under Regulation (EU) 2019/6 can be analysed and published in 2025.

The service is also engaging with veterinary healthcare professionals, such as the recent webinar organised in collaboration with FVE,  on restrictions for the use of certain antimicrobials in animals. Veterinarians, as the first line of defence against emerging diseases, play a crucial role in mitigating the development of antimicrobial resistance.

The Veterinary Antimicrobial Monitoring and Resistance Service looks forward to continuing its collaboration with the European Commission, the EU Regulatory Network, and sister agencies on these important issues over the next few years.

Zoltan Kunsagi
Head of Veterinary Antimicrobial Monitoring and Resistance Service

Veterinary regulatory updates

New Fee Regulation applicable from 1 January 2025

On 7 February 2024, the European Parliament and the Council adopted Regulation (EU) 2024/568 on fees and charges payable to the European Medicines Agency. The 'New Fee Regulation' will apply from 1 January 2025.

 
more
 

Veterinary pharmacovigilance updates

Direct animal healthcare professional communications

The European Medicines Agency publishes direct animal healthcare professional communications (DaHPC) at the EU level to inform veterinarians and other animal healthcare professionals about important safety information regarding veterinary medicines.

 
more
 

Agency news

EMA communication perception survey

The Agency launched its biennial communication perception survey to gather feedback on its external communications from a diverse range of stakeholders, animal health professionals, academics, other regulators, and the pharmaceutical industry. The survey is open until Friday, 21 June 2024.

 
more
 

EMA’s annual report 2023

The European Medicines Agency published its 2023 annual report, detailing the Agency’s contributions to public and animal health in the EU. The report also offers insights into EMA's strategic initiatives and priority areas that guided its work throughout the year.

 
more
 

One Health joint framework for action

Five European Agencies published a joint framework for action to strengthen cooperation to support the implementation of the One Health agenda in the European Union.

 
more
 

Other news

Veterinary novel therapies: your feedback is needed!

The CVMP Novel Therapies and Technologies Working Party launched a survey on veterinary novel therapies. This anonymous survey aims to gain a better overview of novel therapies and innovative veterinary medicinal products under development in Europe, and to identify the main hurdles to their development. The deadline to respond is 30 June 2024.
 
more
 

Call for scientific data on Ketoprofen

The Committee for Veterinary Medicinal Products invites the veterinary pharmaceutical industry, learned societies, governmental institutions, and all EU, EEA and EFTA countries to submit scientific data for use in the review of the residue assessment of ketoprofen until 31 August 2024.

 
more
 

Quality Q&As: update on nitrosamines in VMPs

The European Medicines Agency has updated the guidance regarding impurities, specifically concerning nitrosamines in veterinary medicinal products (VMPs). For detailed information, please consult question 3 in 'Quality of medicines questions and answers - part 1'.
 
more
 

Veterinary IT systems updates

QPPV email addresses in UPD: action required

Marketing authorisation holders will be required to manually add in UPD the relevant email addresses of the Qualified Person for Pharmacovigilance (QPPV) for their products.

 
more
 

Reporting volume of sales of veterinary antimicrobials

EU/EEA Member States must use the Antimicrobial Sales and Use (ASU) platform to report to EMA their data on the volume of sales and use of antimicrobial medicinal products in animals.
 
more
 

Veterinary Big Data

New data scientist joins the Veterinary Division

Paul Damien Lynn joined EMA's Veterinary Division as the new data scientist. In this role, Paul will focus on implementing the veterinary big data strategy and related activities. In addition, he will provide data analytics and identify opportunities in the domain of data science in response to the Division's business needs.
 
more
 

CVMP statistics 2024

Committee for Veterinary Medicinal Products (CVMP) statistics 2024

Detailed information available in CVMP meeting highlights and minutes.
 
more
 

Events and webinars

Webinar on Regulatory Procedure Management for PLM on IRIS

The Regulatory Procedure Management (RPM) for Product Lifecycle Management (PLM) team is hosting a webinar to update marketing authorisation holders on the progress of RPM plans.
Date
date 13/06/2024 - 13/06/2024
 
more
 

Webinar for veterinary marketing authorisation holders on the New Fee Regulation

The Agency invites all veterinary Industry marketing authorisation holders to a webinar on the upcoming changes resulting from the New Fee Regulation.
Date
date 20/06/2024 - 20/06/2024
 
more
 

EMA Quarterly System Demo

EMA is hosting a system demo on 26 June to demonstrate the developments achieved during the second quarter of 2024. Participants have the opportunity see presentations on UPD, UPhD and ASU platform and provide feedback.
Date
date 26/06/2024 - 26/06/2024
 
more
 

Ongoing public consultations

Veterinary-related documents for public consultation

Interested stakeholders are invited to provide their feedback in the following open consultations.

Subscribe, if this email was forwarded to you. | Unsubscribe, if don't want to receive this email anymore. | You can review your personal data on your profile page.

Contact us

The European Commission is committed to personal data protection. Any personal data is processed in line with the Regulation (EU) 2018/1725. Please read the privacy statement.

ISSN: 2811-8707 | Catalogue Number: TC-AM-24-003-EN-Q