Recent EMA veterinary updates on CESSP, the ITF, regulatory submissions and post authorisation best practices

Although the May meeting of the CVMP remained quiet in terms of guidance documents, due to Brexit related business continuity planning (BCP), there have been other updates from the EMA relating to electronic submissions, the ITF, regulatory submissions and post authorisation best practices for VMPs.

Committee for Medicinal Products for Veterinary use (CVMP) meeting May 2019

The EMA has posted the press release with details of the CVMP's meeting of 21 – 22 May 2019 (Link). No new guidance documents were adopted at the meeting, but the committee re-elected Ireland’s David Murphy as chair for another 3 years.

Electronic submissions

A recording of the webinar held on 7^th May, regarding CESSP phase 1, is now available online (Link). A second webinar was also held on 5^th June, aimed at regulators.

Annual reports for 2018

The annual reports for the whole Agency (Link) and from the SME office (Link) have been published. Both of these reports provide a summary of the veterinary activity and the EMA annual report highlights the impact of Brexit BCP on progress at the agency.

Innovation Task Force and AMR

The EMA Innovation Task Force (ITF) is now available for anyone developing critical antibacterial or antifungal products (Link). ITF meetings are free of charge, but how accessible this extension will be to developers of veterinary medicines is not clear, as it is stated that any new medicinal product for the treatment of a life-threatening or debilitating fungal or bacterial infection would be considered.

Regulatory submissions

Two documents have been updated: the template for worksharing procedure requests (Link) and the member state contacts for translation review, with new contact details for Croatia (Link).

Post authorisation Q & A for VMPs

Various Q & A webpages have been extensively revised and it is recommended that any experts in the respective areas review these updated Q & As carefully, to understand the latest in best practices. The following webpages have been updated:

• Changing the (invented) name of a centrally authorised medicinal product (Link)
• Post-authorisation measures: recommendations, conditions and specific obligations (Link)
• Renewals (Link)
• MA transfers (Link)