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Veterinary Medicines Highlights - Issue 16

Read the online version | ISSN 2811-8707

April 2024

Veterinary Medicines Highlights

Quarterly news, activities and interviews from EMA Veterinary Medicines Division

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Editorial

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.

		Veterinarians and animal owners can expect that an approved product is reliably safe and efficacious, in accordance with the regulatory and scientific framework for medicines.

In the area of regulatory affairs, we will continue supporting the output of scientific guidance, taking into account the Commission’s new Guidance to Applicants. Specialist colleagues are supporting a revision of the QRD template for three new and upcoming Commission implementing and delegated acts, aiming to release v.9.1 in July.

The Agency will continue to support Member States in their preparation for collection and reporting of data on antimicrobial medicinal products used in animals. Regular supportive sessions will be held, the outline of the annual report will be developed, and a manual providing guidance on the establishment of a national collection data quality management plan will be published. The first set of data, covering information on the 2023 volume of sales of antimicrobials, will need to be submitted by Member States to the Agency by 30 June 2024.

The next EMA/FVE info session for veterinary healthcare professionals is scheduled for 23 May 2024, this time focusing on information about restrictions of certain antimicrobials related to their use in animals.

Meanwhile, further improvements to the pharmacovigilance database systems will allow increased monitoring capabilities for industry and competent authorities.

I wish you all renewed energy and purpose for the new season.

Emily Drury
Head of Veterinary Surveillance and Regulatory Support Department

Veterinary regulatory updates

Update of marketing authorisation transfer procedure

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

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.

Other news

PSMF reference number and location – call for action

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

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

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

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

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

IRIS for veterinary regulatory procedure management

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

Detailed information available in CVMP meeting highlights and minutes.

CVMP Interested Parties meeting

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.

date

22/05/2024

EMA/FVE info session on restrictions for use of certain antimicrobials in animals

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.

date

23/05/2024

Veterinary-related ongoing open consultations

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

Guideline on the development and manufacture of Synthetic Peptides, until 30 April 2024
Guideline on live recombinant vector vaccines for veterinary use, until 31 May 2024
Guideline on data requirements for veterinary medicinal products for zootechnical purporses, until 31 May 2024

Questions?

Do you have a question for the Veterinary Medicines Division?

The two main channels to contact the Veterinary Medicines 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-24-002-EN-Q