Updated classification rules for certain combination products
Review and adjust labeling and compliance processes for affected combination products as per the new regulations.
Primary source: EMA - What's new RSS
Translated From German
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The agenda was officially published detailing discussions planned on regulatory matters within the Committee for Veterinary Medicinal Products.
Clear communication and disclosure of interests during the CVMP meeting support regulatory compliance and trust within the veterinary medicinal products industry.
Stakeholders should prepare for discussions regarding veterinary medicinal product reviews, specifically focusing on maximum residue limits and ensure all interests are declared by participants.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Stakeholders should prepare for discussions regarding veterinary medicinal product reviews, specifically focusing on maximum residue limits and ensure all interests are declared by participants.
The CVMP meeting scheduled for 8-10 September 2026 will address various veterinary medicinal product topics, including maximum residue limits and declarations of interests from committee members. Participants must declare any interests relevant to agenda items to ensure transparency and manage conflicts of interest.
What changed: The agenda was officially published detailing discussions planned on regulatory matters within the Committee for Veterinary Medicinal Products.
Why it matters: Clear communication and disclosure of interests during the CVMP meeting support regulatory compliance and trust within the veterinary medicinal products industry.
Practical implication: Stakeholders should prepare for discussions regarding veterinary medicinal product reviews, specifically focusing on maximum residue limits and ensure all interests are declared by participants.
Published from the regulator source ingestion pipeline after PV impact triage.
Review and adjust labeling and compliance processes for affected combination products as per the new regulations.
Regulatory Intelligence Leads should update their compliance checks and monitoring processes to align with the new exemption details effective from 1 November 2026.
Review current compliance workflows and adjust processes for monitoring imports under the new packaging rules.
Regulatory teams must prepare for updating labeling to include details on the new indication and required diagnostic methods, along with planning for the confirmatory studies mandated by the FDA.