Veterinary Medicines Highlights - Issue 14
Read the online version | ISSN 2811-8707
  November 2023  

Veterinary Medicines Highlights

Quarterly news, activities and interviews from EMA Veterinary Medicines Division

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Editorial

Welcome to the 14th edition of the Veterinary Medicines highlights. 2023 has been a busy year for the Veterinary Medicines Division at EMA, and although it is swiftly coming to an end, we still have a series of interesting activities planned for you.

Quote Between 18-24 November, we celebrate World Antimicrobial Awareness Week and the contribution and legacy of the ESVAC project, as this EMA initiative comes to an end and its final report is published.

ESVAC’s groundbreaking work will continue under the umbrella of Regulation (EU) 2019/6 with the launch of the ASU platform. You can read more about the Agency’s efforts to ensure member states' preparedness below. Also, early next year the 2019-2021 analysis of antimicrobial consumption and resistance (i.e., the 'JIACRA' report) will be published on our website.

A close relation between veterinary practitioners and regulators is pivotal to support pharmacovigilance surveillance. In that context, we are hosting focus group meetings with animal healthcare professionals on the topic of pharmacovigilance. The first (very) successful meeting with veterinarians specialised in poultry was held in October and the next one with specialised healthcare professionals in aquaculture is scheduled for next week.

We are implementing some improvements in our regulatory processes. Our efficacy experts have published an article providing an overview of guidance available for antiparasitics, the first in a series of publications planned over the near future. We have also initiated some new research initiatives, the first of which is introduced in this newsletter and will be presented further at the Third Veterinary Big Data Stakeholder Forum, which is just around the corner. We have prepared a very interesting programme; you still have time to sign up below.

I hope you enjoy this edition and hope we will see you again in 2024.

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Veterinary regulatory updates
(Invented) names for veterinary medicinal products
Prospective marketing authorisation holder applicants are requested to note that from 1 January 2024, the number of invented name requests submitted for each marketing authorisation application will be limited to two (2).
 
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Antiparasitic veterinary medicinal products

EMA experts published an article on antiparasitic veterinary medicinal products that provides an overview of the current status of reflections and guidance for the development of such, in line with the new regulation.

 
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Discontinuation of the vet.applications mailbox
Marketing authorisation holders are kindly advised that the vet.applications@ema.europa.eu generic mailbox will be fully discontinued as of 1 January 2024.
 
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Update: Linguistic review guideline for veterinary products
Marketing authorisation holders are kindly informed that the Linguistic review guideline for the veterinary centralised procedures and associated documents, including QRD form 1, QRD form 2 and checklists for companies have been updated. Please visit the webpage for detailed information.
 
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Veterinary IT systems updates
Antimicrobial sales and use (ASU)

The ASU platform is in the final stages of development, set its go live in Q1 2024 when member states will commence reporting data directly to the Agency on the volume of sales and use of antimicrobials in animals.

 
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IRIS for veterinary regulatory procedure management
EMA's IRIS platform, currently used for handling veterinary signal management and scientific advice, will broaden its procedural scope for centrally authorised products to include variations requiring assessment (VRA) and marketing authorisation transfers.
 
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Veterinary Medicines Information website improvements
The Veterinary Medicines Information website, the public face of the Union Product Database, is currently receiving improvements to be launched in January 2024.
 
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Veterinary Big Data
Big Data in veterinary medicines regulation: A data landscape analysis
As part of EMA’s research project “Big Data in Veterinary Medicines regulation: A data landscape analysis”, Stichting Wageningen Research (WR) has launched a questionnaire to veterinarians and other animal healthcare professionals.
 
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Third Veterinary Big Data Stakeholder Forum

The third edition of the Veterinary Big Data Stakeholder Forum is just a week away.

 
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CVMP statistics 2023
CVMP statistics
Detailed information available in CVMP meeting highlights and minutes.
 
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Stakeholder engagement: events and webinars
Focus group meeting on pharmacovigilance in aquaculture

The Agency is hosting a Focus group meeting for veterinarians or other healthcare professionals on pharmacovigilance reporting of medicinal products used in aquaculture to gain in-depth knowledge of the challenges faced by these professionals. Attendance is by invitation only.

Date
date 22/11/2023 - 22/11/2023
 
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ASU webinar on animal population protocol
The webinar, oriented at competent authorities, will focus on animal population data templates, instructions for completion and submission on the ASU Platform. Attendance is by invitation only. The recording and materials will be available to competent authorities staff on the EU NTC page.
Date
date 27/11/2023 - 27/11/2023
 
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ASU webinar on data quality
The ASU and UPD product teams are hosting two workshops for competent authorities focusing on enhancing data quality on two separate days. Attendance is by invitation only. The recording and materials will be available to competent authorities staff on the EU NTC page.
Date
date 28/11/2023 - 29/11/2023
 
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Ongoing public consultations
Veterinary-related documents for public consultation
Interested stakeholders are invited to provide their feedback in the following open consultations.
  • Concept paper on the revision of the Guideline on user safety of topically administered veterinary medicinal products, until 30 November 2023
  • Concept paper on a Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products, until 5 January 2024
  • Guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6, until 31 January 2024
  • Guideline on safety and efficacy data requirements for applications for immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6, until 31 January 2024
  • Guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6, until 31 January 2024
  • Guideline on quality data requirements for applications for biological veterinary medicinal products intended for limited markets, until 31 January 2024
  • Guideline on quality data requirements for applications for veterinary medicinal products other than biologicals intended for limited markets, until 31 January 2024
Questions?
Do you have a question for the Veterinary Division?
The two main channels to contact the Veterinary Division are AskEMA and ServiceNow.

If require general information or clarifications, e.g on the implementation of the Veterinary Medicines Regulation, veterinary medicinal products or content on the website, please reach out via AskEMA. If you require technical support, wish to report a bug or are experiencing accessibility issues in one of the EMA IT systems, please open a ticket via ServiceNow.

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ISSN: 2811-8707 | Catalogue Number: TC-AM-23-002-EN-Q