September 2020 EMA news review: the NVR, procedural Q & A, scientific advice, eSubmissions and SMEs

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.

Tiamulin hydrogen fumarate Article 35 referral conclusion

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.

Electronic submissions

Version 1.24.0.0 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.

SMEs newletter

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.

New Veterinary Regulation (EU) 2019/6

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).

Regulatory procedure Q & As

There have been a series of updates to the EMA procedural Q & A webpages:

• Various veterinary pre-submission Q & A updates (Link).
• Updated Q & A on type II variations: Q10. Which post-opinion steps apply to my type II variation and when can I implement the approved changes? (Link)
• Updated Q & A on line extensions: Q5. How shall my extension application be handled (timetable)? (Link).

Scientific Advice submission training

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).