News from the EMA: MUMS; batch safety testing for IVMPs; eSubmissions; MAA validation; AMR and regulatory science

News from the EMA: MUMS; batch safety testing for IVMPs; eSubmissions; MAA validation; AMR and regulatory science
20 November, 2019

The EMA has posted the press release with details of the CVMP's meeting of 5 – 7 November 2019 (Link). General news relating to regulatory affairs included MUMS guidance under the new veterinary medicines regulation (NVR), batch safety testing for vaccines and eSubmissions. Outside the CVMP plenary, the EMA has also published updates on MAA validation, alternatives to antimicrobials, regulatory science and the Agency's monthly activity. 

Article 35 referral for tiamulin hydrogen fumerate

The Committee started an Article 35 referral procedure for VMPs containing tiamulin hydrogen fumarate for pigs presented as premix for medicated feeding stuff and oral powder for in-feed use, due to concerns over efficacy against Brachyspira hyodysenteriae.

MUMS guidance under the New Veterinary Regulation (NVR)

The Committee adopted a concept paper for the revision of scientific guidelines on MUMS/limited markets for VMPs, which takes into account the new provisions concerning limited markets in the NVR. This concept paper will be published for a period of public consultation in the coming weeks.

VICH guidance on batch safety testing for IVMPs

The Committee adopted the draft guideline VICH GL59 on harmonisation of criteria to waive laboratory animal batch safety testing for vaccines for veterinary use (Link).

eSubmission gateway

A new version of the eSubmission Gateway XML delivery file user interface is now available, which leads to the abolishment of the need for the Formatted Table Template as a part of the submission cover letter, with effect from 1 January 2020 (Link).

Validation checklists for initial MA applications

Validation checklists for initial MA applications for veterinary pharmaceutical (Link) and immunological (Link) products are now available, providing applicants with the same checklists as used by assessors during validation.

Alternatives to veterinary antimicrobials

The CVMP draft reflection paper on ‘Promoting the authorisation of alternatives to antimicrobials in the EU’ has now been published for public consultation (Link).

Regulatory Science 2025

The EMA is holding a multi-stakeholder workshop on its Regulatory Science to 2025 strategy, on 5 – 6 December, which will be by invitation only. However, the event will be broadcast live on the EMA website, for any interested parties and a recording of the event will be available after the event (Link).

Monthly activity at the EMA and 2019 guidance status

Aug – Sep monthly report on application procedures, guidelines and related documents for veterinary medicines now published (Link). This includes on the final pages a summary of the current status of 2019 guidelines and working documents.

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As well as providing unique insights into our clients' projects, our collaboration with Dr. Holm also includes regulatory training courses. Follow the links below for more information.
- Central VetPharma website
- Training event: Innovative VMPs


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