Revised guideline on veterinary medicinal products for zootechnical purposes (28/02/2025)

The CVMP adopted a revised guideline on veterinary medicinal products for zootechnical purposes at its January 2025 meeting. Applicable from 1 August 2025, the guideline provides specific guidance on data requirements for efficacy and target animal safety.

Camelia's editorial (26/02/2025)

Welcome to the 20th edition of the Veterinary Medicines newsletter. My name is Camelia Mihaescu, I am a pharmacist with almost 20 years experience in regulatory affairs, clinical trials and pharmacovigilance in the human medicines domain. I joined the Veterinary Medicines Division at EMA as Head of Veterinary Pharmacovigilance five months ago and I am excited to use my experience and dive into the world of veterinary medicines.

New QRD template v.9.1 (28/02/2025)

Applicants are reminded that for any new marketing authorisation applications validated on or after 10 March 2025, QRD template version v.9.1 should be used. Detailed information, including a QRD implementation plan, can be found on the Veterinary product information (QRD) templates landing page.

Recording of EMA/FVE webinar on the use of the prescription cascade (28/02/2025)

On 16 January 2025, the Agency hosted a webinar targeted at veterinarians on veterinary prescription and the conditions for using certain antimicrobials under the 'cascade’. The recording of the event, together with the presentation is publicly available. The Q&A document will be published in the upcoming weeks.

New landing page on the One Health approach (28/02/2025)

The Agency launched a new landing page on the One Health approach, emphasising the interconnectedness of human, animal, and environmental health.

EMA recommended the authorisation of two vaccines against BTV-3 (28/02/2025)

EMA's Committee for Veterinary Medicinal Products recommended the approval of two vaccines to protect sheep and cattle against the newly emerged serotype-3 bluetongue virus.

Veterinary medicines in 2024 (28/02/2025)

EMA has published an overview of its key recommendations from 2024 regarding the authorisation and safety monitoring of veterinary medicines.

Update to the VNRA list (05/03/2025)

Commission Implementing Regulation (EU) 2025/163 established a revised list of variations not requiring assessment (VNRAs). An updated list will apply from 20 April 2025.

New read-only API for the veterinary industry and general public (28/02/2025)

On 31 January 2025, the Union Product Database (UPD) introduced a read-only application programming interface (API) for veterinary pharmaceutical industry users and the general public, providing seamless access to product data for all veterinary medicines in the EU.

UPD email notification functionality (05/03/2025)

UPD super users from both marketing authorisation holders (MAH) and national competent authorities (NCAs) can configure email addresses to receive notifications about product-related actions.

Veterinary big data updates (28/02/2025)

EMA’s veterinary analytics team is happy to share updates for a selection of ongoing veterinary initiatives in the big data and artificial intelligence (AI) space.

Committee for Veterinary Medicinal Products (CVMP) statistics 2025 (28/02/2025)

Detailed information available in CVMP meeting highlights and minutes.

EMA Veterinary Innovation Day (13/03/2025)

Three years after Regulation 2019/6 came into effect, the Agency is hosting a second edition dedicated to the topic of innovation. The draft programme is publicly available and registration to follow the discussions virtually is ongoing.

Certificates Processing System (13/03/2025)

From 1 January 2025, EMA certificates of medicinal products must be ordered through the Certificates Processing System. Register for the demo and Q&A session scheduled for 13 March 2025 and submit questions in advance.

Quarterly System Demo – Q1 2025 (26/03/2025)

On 26 March 2025, the Agency is holding a public system demo to demonstrate the latest achievements, and this edition includes a session on the Union Product Database. Participants can follow the live broadcast and provide feedback to the different teams.

3Rs Working Party (3RsWP) public session on the 2025-2027 work plan (02/04/2025)

The 3RsWP is hosting a virtual public session to present its work plan for 2025-2027 and priorities for 2025. Stakeholders will have an opportunity to comment and provide their views on the working party's activities.

ADRA project - info session for veterinary pharmaceutical industry (22/05/2025)

The Agency is hosting an info session on the ADRA project for the veterinary pharmaceutical industry. Registration is now open, and questions can be submitted in advance.

Veterinary-related open consultations (28/02/2025)

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

Do you have a question for the Veterinary Medicines Division? (12/08/2023)

The two main channels to contact the Veterinary Medicines Division are AskEMA and ServiceNow.

Committee for Veterinary Medicinal Products (CVMP) statistics 2024 (03/12/2024)

Detailed information available in CVMP meeting highlights and minutes.

Editorial #19 (28/11/2024)

Welcome to the 19th edition of the Veterinary Medicines Highlights. As we leave 2024 behind and reflect on the achievements of the Veterinary Biologicals Service, it is clear that this has been a remarkable and busy year for biologicals and emerging therapies. Let me walk you through our key achievements.

New QRD template (28/11/2024)

EMA will publish version 9.1 of the veterinary QRD product information before 31 December 2024. The new template will be available in all EU languages, with translations expected to be completed by the end of January 2025.

New fee regulation applicable from 1 January 2025 (28/11/2024)

Regulation (EU) 2024/568 on fees and charges payable to the European Medicines Agency will come into effect on 1 January 2025.

Conclusion of first targeted signal management procedure (28/11/2024)

In March 2023, CVMP and CMDv started a targeted signal management procedure for injectable veterinary medicinal products in combination with anaphylactic reactions in cattle. The procedure was concluded, and the outcome will be published on the week of 9th December 2024.

EMA certifies the first veterinary vaccine platform technology master file (28/11/2024)

EMA's Committee for Veterinary Medicinal Products has issued the first certificate for a vaccine platform technology master file which will support and accelerate the development and authorisation of new veterinary vaccines in the EU.

EMA guidance on veterinary medicinal product classification (28/11/2024)

The CVMP developed a question-and-answer document, clarifying the rationale for the classification of veterinary medicinal products. For detailed information, please consult question 1.4 of the “Pre-authorisation guidance”.

UPD annual volume of sales: submission deadline 28 February 2025 (28/11/2024)

Marketing authorisation holders are reminded that the deadline for the submission of the annual volume of sales data for each veterinary medicinal product in the Union Product Database (UPD) is 28 February 2025.

UPD refresher webinar on basic functionalities (28/11/2024)

On 7 November 2024, EMA hosted a refresher webinar for competent authorities on UPD basic functionalities to reinforce knowledge, address common inaccuracies, and share best practices. The recording and the presentation shared are now available in EU NTC.

ASU Platform entering maintenance (28/11/2024)

The development of the Antimicrobials Sales and Use (ASU) platform has concluded, with all required functionalities successfully delivered. Beginning in 2025, the system will transition into maintenance phase, focused to monitoring and bug fixing.

Union Pharmacovigilance Database entering maintenance (28/11/2024)

The development of the Union Pharmacovigilance Database (UPhD) has concluded, with all required functionalities successfully delivered. Beginning in 2025, the system will transition into maintenance phase, focused to monitoring and bug fixing.

4th Veterinary Big Data Stakeholder Forum: recording now available (28/11/2024)

On 14 October 2024, the Agency hosted the 4th edition of the annual Veterinary Big Data Stakeholder. The recording of the event, together with the speaker's presentations, is now publicly available.

Veterinary Big Data: 2024 highlights (29/11/2024)

EMA’s Veterinary Analytics Team had a successful and productive 2024, marked by important achievements and increased engagement with stakeholders.

UPD refresher webinar on annual submission of volume of sales (05/12/2024)

The Agency invites veterinary industry stakeholders to a refresher webinar on the submission volume of sales data in the Union Product Database (UPD). The event is scheduled for 5 December and registration is ongoing.

Quarterly public system demo – Q4 2024 (12/12/2024)

On 12 December 2024, the Agency is holding a public system demo to demonstrate the latest achievements on the new fee regulation, regulatory procedure management for product lifecycle management on IRIS, and Union Product Database (UPD). Participants can follow the live broadcast and provide feedback to the different teams.

Assessors training on limited markets classification and data requirements (10/12/2024)

Two half-day training session for veterinary safety and efficacy assessors on 10 and 11 December 2024. Registration for webinar participation is open until 5 December 2024.

EMA/FVE webinar on the use of the prescription cascade (16/01/2025)

The Agency is hosting a webinar targeted at veterinarians on the use of the prescription cascade on 16 January 2025. Registration is now open and veterinary healthcare professionals can submit questions in advance.

EMA Veterinary Innovation Day – SAVE THE DATE (13/03/2025)

Three years after Regulation 2019/6 coming into effect, the Agency is hosting a second edition dedicated to topic of innovation. Details on the programme and speakers will be made available in February 2025.

Veterinary-related open consultations (28/11/2024)

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

Editorial #18 - Nick Jarrett (28/08/2024)

Welcome to the 18th edition of the Veterinary Medicines newsletter. Returning to our desks as the summer slips away, at the Veterinary Pharmaceuticals service we are beginning to feel a degree of familiarity with some of the procedural and regulatory changes brought about by Regulation 2019/6. Yet the months ahead promise plenty in the way of activity and change.

New Fee Regulation applicable from 1 January 2025 (03/06/2024)

The 'New Fee Regulation' will apply from 1 January 2025 and to support and inform the industry about the transition, the European Medicines Agency is hosting a second webinar on the major changes.

New DaHPC published (03/06/2024)

The European Medicines Agency published in July 2024, a new direct animal healthcare professional communications (DaHPC). DaHPCs are designed to inform veterinarians and other animal healthcare professionals about important safety information regarding veterinary medicines.

EU updates antimicrobial use rules in animal health under the ‘cascade' (03/09/2024)

As part of the ongoing implementation of Regulation (EU) 2019/6, the European Commission adopted new legislation establishing a list of antimicrobials which shall not be used in accordance with Articles 112 and 113 of Regulation.

EMA publishes scientific advice on essential substances for equine treatment (03/09/2024)

The EMA published scientific advice regarding a 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.

7th VICH Public Conference - register by 30 September (03/09/2024)

The European Medicines Agency is co-hosting the 7th VICH public conference in Amsterdam, on 13-14 November 2024, under the theme “VICH and a new era”. This in-person conference is held every five years and registration is open until 30 September. The conference’s programme is now available.

ASU - Reporting of use data of veterinary antimicrobials (04/09/2024)

The 2023 data call of the reporting activities collected under Article 57 of Regulation (EU) 2019/6 continues.

UPD - QPPV email addresses: submission extended until 31 October 2024 (04/09/2024)

Marketing authorisation holders are to manually add the email addresses of the Qualified Person for Pharmacovigilance (QPPV) for their products in UPD by 31 October 2024.

IRIS - Register in EMA IAM and update product contacts by 31 October 2024 (16/07/2024)

Marketing authorisation holders (MAHs) product contact points are to ensure they are registered in the EMA Account Management System by October 2024. This is part of the transition of all EMA-led post-authorisation procedures to IRIS planned for January 2025.

4th Veterinary Big Data Stakeholder Forum – register now (04/09/2024)

The 4th edition of the annual Veterinary Big Data Stakeholder forum is set to take place on 14 October 2024, 10:00-15:00 CEST.

Committee for Veterinary Medicinal Products (CVMP) statistics 2024 (04/04/2024)

Detailed information available in CVMP meeting highlights and minutes.

Quarterly public system demo - Q3 2024 (18/09/2024)

On 18 September 2024, the Agency is holding a public system demo event. Participants have the opportunity to see presentations on New Fee Regulation and the Union Product Database (UPD) and provide feedback.

EMA Account Management, what's new? (20/09/2024)

On 20 September 2024, the Agency is hosting a webinar for industry and national competent authorities on the new functionalities introduced in EMA account management.

4th Veterinary Big Data Stakeholder Forum (14/10/2024)

The 4th edition of the annual Veterinary Big Data Stakeholder forum is scheduled for 14 October 2024, 10:00-15:00 CEST. Registration is ongoing and the draft agenda is now publicly available.

UPD webinar for veterinary marketing authorisation holders on an industry-dedicated read API (17/10/2024)

Veterinary marketing authorisation holders will be able to connect to the Product Database (UPD) through a dedicated industry API to help streamline data access and support business processes. The Agency is hosting a webinar for industry on this topic and registration is ongoing.

Webinar for veterinary marketing authorisation holders on the New Fee Regulation (24/10/2024)

The Agency is hosting a second webinar on the upcoming changes resulting from the New Fee Regulation on 24 October 2024. Registration is now open and veterinary industry representatives can submit questions in advance.

UPD refresher webinar for national competent authorities on data submission (07/11/2024)

As part of the Agency's commitment to the improvement of the Union Product Database (UPD), national competent authorities are invited to attend a refresher webinar on data submission on 7 November 2024. During this event, the team will demo best practices and highlight must common inaccuracies. Attendance is by invitation only.

UPD webinar for veterinary marketing authorisation holders on volume of sales submission (05/12/2024)

The Agency invites veterinary industry stakeholders to a dedicated webinar on the submission of 2024 volume of sales data in the Union Product Database (UPD). During the session, we will provide a step-by-step demonstration of the submission process and highlight how to avoid common mistakes that may lead to delays or known errors.

Veterinary-related documents for public consultation (29/01/2024)

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

Editorial #17 - Zoltan Kunsagi (31/05/2024)

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.

EMA communication perception survey (03/06/2024)

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.

EMA’s annual report 2023 (03/06/2024)

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.

One Health joint framework for action (05/06/2024)

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.

Veterinary novel therapies: your feedback is needed! (03/06/2024)

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.

Call for scientific data on Ketoprofen (03/06/2024)

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.

Quality Q&As: update on nitrosamines in VMPs (03/06/2024)

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'.

QPPV email addresses in UPD: action required (03/06/2024)

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.

Reporting volume of sales of veterinary antimicrobials (04/06/2024)

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.

New data scientist joins the Veterinary Division (05/06/2024)

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.

Webinar on Regulatory Procedure Management for PLM on IRIS (13/06/2024)

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.

Webinar for veterinary marketing authorisation holders on the New Fee Regulation (20/06/2024)

The Agency invites all veterinary Industry marketing authorisation holders to a webinar on the upcoming changes resulting from the New Fee Regulation.

EMA Quarterly System Demo (26/06/2024)

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.

Editorial ED (05/04/2024)

Welcome to the 16th edition of the Veterinary Medicines newsletter. As we move into Q2 of 2024, the Veterinary Surveillance and Regulatory Support Department is looking ahead at the ‘to-do’ list for the coming months.

Update of marketing authorisation transfer procedure (04/04/2024)

Veterinary marketing authorisation holders will now benefit from a simplified transfer procedure, with new templates and fewer required attachments. Updated questions and answers are available on the EMA corporate website. MAHs can still use previous templates until 30 June 2024.

New legislation on abbreviations, pictograms and small packaging (04/04/2024)

As part of the ongoing implementation of Regulation (EU) 2019/6, the European Commission recently adopted legislation on pictograms and abbreviations, as well as on small packaging units which will apply from 11 May 2024.

PSMF reference number and location – call for action (08/04/2024)

Marketing authorisation holders for centrally authorised veterinary medicinal products who have not yet provided the Pharmacovigilance system master file (PSMF) reference number and location are strongly encouraged to submit a VNRA code C.6 as soon as possible.

Submission of G.I.18 VRAs at national level (04/04/2024)

The Coordination Group for Mutual Recognition and Decentralised Procedures for Veterinary Medicinal Products (CMDv) recently held a workshop on G.I.18 Variations Requiring Assessment (VRA), specifically oriented at national competent authorities. The outcome of the discussions, along with a recording of the workshop, are now accessible via the EU Network Training Centre.

Guideline on plasmid DNA vaccines for veterinary use (04/04/2024)

In January 2024, a revised version of the guideline on plasmid DNA vaccines for veterinary use was published, as part of the Agency’s activities to support innovation. The update includes alignment with Regulation (EU) 2019/6 and additional clarifications, resulting from experience gained from the procedures of the two first centrally authorised veterinary DNA vaccines.

Guideline on the need for an MRL evaluation for chemical-unlike biological substances (04/04/2024)

The CVMP has adopted guidance concerning the assessment criteria to determine of the need for a MRL evaluation for chemical-unlike biological substances. This guideline seeks to clarify the data requirements and rules on the need for an MRL evaluation for chemical-unlike biological non-immunological substances used in VMPs, intended for use in food-producing species.

Downtime and decreased functionality for multiple EMA Systems (04/04/2024)

EMA is planning a significant IT maintenance operation for 11-17 April 2024.

IRIS for veterinary regulatory procedure management (04/04/2024)

Progress is being made on the integration of additional regulatory procedures for centrally authorised veterinary products in the IRIS EMA platform.

CVMP Interested Parties meeting (22/05/2024)

On 22 May 2024, CVMP will hold its annual Interested Parties meeting, in a dedicated space outside other major fora to engage with stakeholders on the work of the CVMP, and facilitate opportunities for discussion between Committee members and representatives of the CVMP Interested Parties. Participation will be by invitation only.

EMA/FVE info session on restrictions for use of certain antimicrobials in animals (23/05/2024)

In collaboration with the Federation of Veterinarians of Europe, the Agency is hosting an info session for veterinary healthcare professionals to address restrictions on the use of certain antimicrobials in animals. Register by 22 May 2024.

Veterinary-related open consultations (26/01/2024)

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

Editorial #15 (28/01/2024)

Welcome to the 15th edition of the Veterinary Medicines newsletter. As we leave behind a busy 2023, we at the Veterinary Evaluation and Innovation Department are excited to embark on a stimulating year.

G.I.18 variations - submissions at national level (26/01/2024)

The national competent authorities (NCA) within the Coordination Group for Mutual Recognition and Decentralised Procedures for Veterinary Medicinal Products (CMDv), are monitoring the submission of the G.I.18 variation requiring assessment (VRA) three times a year.

Update of SME user guide (23/01/2024)

The revised SME user guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorisation of medicines for human and veterinary use. The document has been fully revised to align with the veterinary regulation.

Union Product Database: 2023 volume of sales submission (30/01/2024)

The deadline for marketing authorisation holders to submit the volume of sales data for the calendar year 2023 is 29 February 2024.

New platform for collection of sales and use data of antimicrobials in animals (29/01/2024)

EMA has just launched the new Antimicrobial Sales and Use (ASU) platform to support the mandatory collection of data by Member States on the sales and use of antimicrobials in animals.

Discontinuation of the vet applications mailbox (05/09/2023)

Veterinary processes previously communicated via the vet applications mailbox must be requested, from 1 January 2024, via EMA’s Service Now.

First roll-out on IRIS for veterinary regulatory procedure management (24/01/2024)

Variations requiring assessment (VRA) and marketing authorisation transfers were onboarded on EMA's IRIS platform for a subset of veterinary medicinal products on 23 January 2024.

Belgian presidency Council of the European Union (01/01/2024)

January marks the begining of the Belgian presidency of the Council of the European Union. Under the Belgian Presidency, health will revolve around three overarching themes: preparedness, care, and protection. Antimicrobial resistance is one of the greatest public health threats of our time. The Presidency will focus its efforts on combating antimicrobial resistance in a cross-sectoral approach, embracing the "One World One Health" principle, addressing human, animal and environmental health.

Veterinary Medicines: highlights 2023 (28/01/2024)

EMA has published an overview of its key recommendations of 2023 regarding the authorisation and safety monitoring of veterinary medicines.

EMA/FVE information session on the UPD public portal (21/02/2024)

The Agency, in collaboration with the Federation of Veterinarians of Europe, is hosting an info session on the Veterinary Medicines Information website, which recently underwent a redesign, introducing enhanced functionalities for a more user-friendly experience.

Veterinary Medicines Info Day 2024 (14/03/2024)

The European Medicines Agency is organising the annual Veterinary Medicines Info Day to provide the latest updates on regulatory policy, scientific and legislative developments in the veterinary medicines domain

Editorial #14 (07/11/2023)

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.

(Invented) names for veterinary medicinal products (31/10/2023)

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).

Antiparasitic veterinary medicinal products (07/11/2023)

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.

Update: Linguistic review guideline for veterinary products (16/11/2023)

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.

Antimicrobial sales and use (ASU) (07/11/2023)

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.

IRIS for veterinary regulatory procedure management (31/10/2023)

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.

Veterinary Medicines Information website improvements (05/09/2023)

The Veterinary Medicines Information website, the public face of the Union Product Database, is currently receiving improvements to be launched in January 2024.

Big Data in veterinary medicines regulation: A data landscape analysis (07/11/2023)

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.

Third Veterinary Big Data Stakeholder Forum (07/11/2023)

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

Focus group meeting on pharmacovigilance in aquaculture (22/11/2023)

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.

ASU webinar on animal population protocol (27/11/2023)

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.

ASU webinar on data quality (28/11/2023)

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.

Editorial (04/09/2023)

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

Veterinary Pharmacovigilance: updated webpage (04/09/2023)

The Veterinary Pharmacovigilance webpage has been revamped with fresh and updated content, organised to simplify information retrieval for animal health professionals, the regulatory network, and industry stakeholders.

Committee for Veterinary Medicinal Products (CVMP) Statistics 2023 (31/08/2023)

Detailed information available in CVMP meeting highlights and minutes.

Antimicrobial sales and use (ASU) Platform (04/09/2023)

The development of the ASU platform progresses as key milestones approach. As we move into Q4 2023, testing activities are ongoing to prepare for the system go-live in January 2024.

Union Product Database: data quality framework (04/09/2023)

Following the launch of the UPD Data Quality Framework (DQF) in April 2023, the concerted efforts of National Competent Authorities (NCAs) have resulted in a substantial enhancement of data quality within UPD.

Veterinary Data Hub formally established (04/09/2023)

Established in June 2023, the Veterinary Data Hub brings together a multidisciplinary team of experts from Belgium, France, Germany, Portugal, Spain, and Sweden. This group of experts collaboratively engages in advancing the EU Veterinary Big Data strategy and actively contributes to the planned activities within this framework.

Big Data in Veterinary Medicines Regulation: A Data Landscape Analysis (04/09/2023)

EMA is funding a research project entitled “Big Data in Veterinary Medicines Regulation: A Data Landscape Analysis”. The project is funded under the EMA framework contract for Quality, Efficacy and Safety studies on veterinary medicines.

LinkedIn Live interview with Ivo Claassen (07/09/2023)

Register now for the live event on LinkedIn with Ivo Claassen. The Head of the Veterinary Medicines Division will discuss how human and animal health are closely interlinked, and the need for innovation in veterinary medicines for the benefit of animal and public health, and the environment.

EMA Veterinary Awareness Day (12/09/2023)

EMA's first ever Veterinary Awareness Day will take place on 12 and 13 September 2023. Register now to get an insight into how our work in the field of veterinary medicine benefits public and animal health and the environment.

UPD webinar on product grouping and third country product names (18/09/2023)

Register now for the upcoming UPD webinar, scheduled for 18 September 2023. Oriented at Industry users, the UPD team will demonstrate how to group essentially similar products and matching of non-EEA product names with EEA-authorised products.

Quarterly System Demo – Q3 2023 (21/09/2023)

On 21 September, the Agency is holding a system demo event which will showcase, among others, the developements achieved in Q3 2023 for the Union Product Database (UPD).

ASU webinar for competent authorities on data quality (25/09/2023)

The ASU product team is hosting a webinar on ASU and UPD data quality for national competent authorities, on 25 September 2023. Formal invitations to these webinars have be sent to the relevant stakeholders.

Third Veterinary Big Data Stakeholder Forum (23/11/2023)

The third edition of the Veterinary Big Data Stakeholder Forum is scheduled for 23 November 2023. Register now.