CMDv report for release presents new variation guidance and discussions with stakeholders about the new veterinary regulation

European regulators discuss variations and and the new veterinary regulation at CMDv
19 November, 2019

The latest CMDv Report for Release, giving an overview of the activities of the September and October 2019 meetings, is available to view and download (Link). The minutes from the 11 October CMDv interested parties meeting have also been published (Link).

CMDv Report for Release provides updated advice on variations

The report includes amongst other items:

  • CMDv-interested parties meeting October 2019 (see below)
  • New Q&A (Q3.14) on classification of variations, regarding definition of complex manufacturing processes (Link).
  • New recommendation for classification of an unforeseen variation agreed by CMDv, CMDh and EMA (change in testing frequency of specification parameter) – see CMDh Excel list (Link).
  • Notice on “Reduction in Administrative Burdens Relating to Variations” updated, covering amongst other subjects, changes which can be accepted as variation “Supergroupings” (Link).

CMDv discusses implementation of the NVR with stakeholder groups

The majority of the interested parties meeting concerned the plans and consultation process for implementation of the new veterinary regulation, particularly focusing on:

  • SPC harmonisation
  • Possible shift of workload with widened scope for the CP
  • Variations not requiring assessment

Also discussed at the IP meeting were additional national requirements and veterinary medicines shortages.

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