"Veterinary Medicines Highlights" Newsletter Issues

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.

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

Detailed information available in CVMP meeting highlights and minutes.

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 ongoing open consultations (26/01/2024)

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

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.

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

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

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.