EMA Vet: Guidance on Reduced Timetable Oral Explanations at CVMP

The European Medicines Agency (EMA) provides guidance to applicants/marketing authorisation holders (MAHs) on oral explanations at the Committee for Medicinal Products for Veterinary Use (CVMP) or the Veterinary Medicinal Product Assessment (VRA) on a reduced timetable. According to EMA guidance, no advance notice is required for these oral explanations, which can be held at the request of either the CVMP or MAH.

The CVMP assesses responses to requests for supplementary information within 30 days. In cases where variations require an inspection, a clock-stop of up to six months may be applied. This clock-stop allows for additional time to address any outstanding issues before proceeding with the assessment.

MAHs should submit requests for extensions to the clock-stop period of longer than one month to the Agency for agreement by CVMP. The length of the clock-stop period will depend on the complexity of the questions, but a general rule is that it will be up to one month.

The clock may only be stopped once in cases where subsequent variations follow both reduced and standard timetables. All responses to requests for supplementary information must be submitted through the eSubmission Gateway/Web Client. The clock-stop period will continue until all supplementary information has been received.

In cases where issues are identified that prevent the adoption of an opinion, the CVMP will issue a request for supplementary information or a list of questions and inform the MAH of the deadline for submitting the requested data. The rapporteur circulates an assessment report to the CVMP, which then adopts an opinion on all timetables.

Overall, EMA guidance aims to facilitate efficient communication between stakeholders in the veterinary medicinal product development process, ensuring that variations are assessed promptly and effectively while also allowing for flexibility in addressing complex issues. By following these guidelines, MAHs can ensure a smoother path for their products through the regulatory process.

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