The NVR and updates on eSubmission, the ASMF and veterinary antibiotic usage, as EMA says goodbye to Guido Rasi.

EMA says goodbye to Guido Rasi and welcomes Emer Cooke. November sees publication of the latest quarterly newsletter on the New Veterinary Regulation (NVR) highlights the ongoing work on its implementation, whilst there have been other updates on eSubmission, the ASMF and veterinary antibiotic usage. 

CVMP plenary meeting November 2020

The EMA has posted the press release with details of the CVMP's meeting of 3 – 5 November 2020 (Link). All news was product specific, with no new guidance or regulatory updates.

eSubmission

The latest guidance on eSubmission for veterinary products (v2.7) is now in force (Link). The eAF for variations has also been updated to fix an issue with Adobe compatibility and a note to users has been posted (Link).

From 21st October, Lithuania’s State Food and Veterinary Service has joined the CESP system and will accept veterinary submissions (Link).

New Veterinary Regulation (NVR)

The EMA's quarterly publication, “Veterinary Medicines Regulation Highlights” issue 2 has now been published, discussing the ongoing activity in implementation of the NVR (Link).

The latest release notes for the Union Product Database are also now available (Link) and a draft concept paper on the reporting of antimicrobial sales and use in animals at the EU level has been published for consultation until 31 Jan 2021 (Link).

Active Substance Master File (ASMF)

Various Q&As have been updated relating to the submission of the ASMF (Link).

Other news

The EMA has published the latest ESVAC report and a new infographic “Responsible use of antibiotics protects animals and people”, promoting OneHealth (Link). Sales of antibiotics for use in animals in Europe fell by more than 34% between 2011 and 2018.

The latest EMA monthly report (August – September 2020) is now available, including a summary of ongoing referrals and all draft and final guidance documents adopted so far in 2020 (Link).

Scientific advice submission deadlines for 2021 have been published (Link).

Finally, there has been a parting message from outgoing Executive Director, Guido Rasi (Link) and an open letter from Management Board Chairs (Link) prior to Emer Cooke starting in the role from 16 November 2020 (Link).