KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: FEBRUARY 2024

The EMA has published the agenda and minutes of the CVMP meeting that took place on 16-18 January 2024. As well as product-related discussions and decisions, scientific guidelines were adopted by some of the Working Parties, and there were legislative discussions relating to the 3Rs principles and the EC’s 'One substance, one assessment' initiative, as well as progress on Implementing Acts relating to Articles 115(5) and 114(3) of Regulation 2019/6. The agenda and highlights from the meeting on 13-15 February are also available.

EMA/CVMP

GUIDELINES AND CONSULTATIONS

• The new CVMP scientific Guideline on determination of the need for an MRL evaluation for chemical-unlike biological substances has been adopted and comes into effect in August 2024.
• The new CVMP scientific guideline on plasmid DNA vaccines for veterinary use has adopted and will come into effect in July.
• Consultation has opened on revision of the Guideline on VMPs for zootechnical purposes, with comments invited until the end of May.
• Consultation is open on Revision 1 of the Guideline on live recombinant vector vaccines for veterinary use, with comments invited until 31st May.

TRAINING AND EVENTS

• The EMA’s 2024 Veterinary Medicines Info Day will take place in-person and online on 14-15 March. The agenda and link to register are on the event page.
• An EMA technical webinar for those interested in Regulatory Procedure Management (RPM) for Product Lifecycle Management (PLM) for medicinal products in IRIS took place on 27 February. See the event page here.
• The presentations from the training webinar for Regulatory Procedure Management first roll-out on IRIS that took place on 16th January, and the update webinar on RPM for Product Lifecycle Management on IRIS that took place on 13th February, are now available on the respective event pages.
• Presentations from the 21 February webinar on UPD functionality from a veterinary practitioner perspective, hosted by EMA and Federation of Veterinarians of Europe (FVE), are available on the event page.

PROCEDURAL ADVICE AND Q&A

• EMA have issued a new fee Regulation (Regulation EC 2024/568). It will come into effect from 1st January 2025.
• There is new guidance and an administrative template for notifying EMA of changes to contact persons for veterinary medicines: see this page.
• A new Q&A document on how to use a CEP in the context of a MA Application or a variation has been published jointly by CHMP and CVMP.
• EMA/CVMP have published revised procedural guidance on the accelerated MA assessment procedure, for VMPs within the scope of Article 44(3) of Regulation 2019/6.
• EMA's SME office has published a user guide for SMEs that aims to improve understanding of the main aspects of medicinal product legislation, and sets out administrative and procedural provisions in the legislation of relevance to SMEs.
• EMA have also published a document summarising the provisions made for SMEs by the EU National Competent Authorities.
• Revision 3 of the Procedural advice to applicants/MAHs on re-examination of CVMP opinions was published in February.
• A second revision of the EMA/CMDv procedural advice and recommendations on VRAs not already listed has been issued.
• EMA have published a Q&A document on Regulatory Procedure Management for the Product Lifecycle Management, which includes amongst other things clarification on the approach to submission of VRAs via IRIS in the future.
• A second revised version of the EMA submission dates for veterinary procedures has been published.
• A Version 1.6 of the Implementation Guide (IG) for VMP data in the UPD, Chapter 2 – format for e-submissions – has been published.
• The UPD FAQ (for industry use) has been updated to Version 1.3. 
• The EVVet3 Production Release notes, version from 31 January 2024, are available.

REFERENCE AND REPORTS

• EMA have published their Annual Activity Report for 2022, which can be found here.
• The fourth inter-agency JIACRA report on antimicrobial consumption and AMR has been published, presenting data collected between 2019 and 2021. A related news item can be found here, and a summary overview of the report here.
• EMA has published Antimicrobial Sales and Use (ASU) Platform User Guide. Chiefly aimed at NCA users, the document may provide useful reference information to MAHs as well.

WORKING PARTIES

2024 Work plans have been published for the following CVMP working parties:

• Immunologicals Working Party (IWP)
• Efficacy Working Party (EWP-V)
• European Sales and Use of Antimicrobials in veterinary medicine Working Group (ESUAvet WG)
• Pharmacovigilance Working Party (PhVWP-V)
• Environmental Risk Assessment Working Party (ERAWP)
• Antimicrobials Working Party (AWP)
• Scientific Advice Working Party (SAWP-V)
• Safety Working Party (SWP-V)
• Novel Therapies & Technologies Working Party (NTWP)
• Joint CHMP/CVMP Quality Working Party (QWP).

HMA/CMDV

• The latest CMDv Report for release, giving an overview of the activities of the November and December 2023 meetings, is available to view and download.
• A new Best Practice Guide is available for advice from CMDv on regulatory matters. The BPG describes the process followed after receipt of a regulatory enquiry by CMDv from industry or a regulatory body.
• The ‘Advice from CMDv’ page of the HMA website has been updated to include a clarification relating to Art. 65 of Regulation 2019/6, for cases where it is mandatory to submit a work-sharing application.