The EMA has posted the press release with details of the CVMP's meeting of 8 – 9 September 2020 (Link). Updates from the plenary meeting and other news from the EMA is summarised below.
The Article 35 referral, for VMPs containing tiamulin hydrogen fumarate for in-feed use for pigs, was concluded, with the recommendation that there was insufficient efficacy data to support the indication for prevention or metaphylaxis of swine dysentery caused by Brachyspira hyodysenteriae.
Version 126.96.36.199 of all four electronic Application Forms (eAFs) is now available, introducing a major change in section 3 of the variation form, by further integrating with RMS from SPOR (Link). Mandatory use starts 16 December 2020.
The latest SME newsletter has been published, with veterinary updates on: the new veterinary regulation; biological substances not requiring an MRL evaluation; reflection paper on Article 40(5) of the NVR (protection of technical documentation for data developed to support innovations to an existing marketing authorisation); pharmacovigilance.
The EMA has published its latest input in the implementation of the NVR, with publication of the "Scientific problem analysis and recommendations to ensure a safe and efficient administration of oral veterinary medicinal products via routes other than medicated feed" (Link).
There have been a series of updates to the EMA procedural Q & A webpages:
The EMA has announced a new training event, to be held on 14 October: "How to submit Initial and Follow-up Scientific Advice applications (veterinary) using IRIS" (Link). Also available is a new guide on registration with IRIS (Link) and a quick interactive guide (Link).