Webinar – Changes to the regulatory framework for veterinary medicines

On 1 November 2023, the HPRA held a webinar for marketing authorisation holders of veterinary medicines to provide information on changes to the regulatory framework, consequent to the introduction of Regulation 2019/6 and associated new national legislation.

The video recordings of the two webinar sessions are available to view below.

A Questions and Answers document was developed to provide further information on topics discussed in the webinar. The document is available to download.

If you wish to receive a copy of any of the presentations from the webinar, you can request them by emailing vetinfo@hpra.ie

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Session 1: Developments in the authorisation and monitoring systems for veterinary medicines

Welcome and opening address

Lorraine Nolan and J. Gabriel Beechinor, HPRA

CMDv updates affecting procedures

Rhona McHugh, HPRA

Recent experience with VNRAs

Eabha Hussey, HPRA

Progress with the UPD

Cathy Hempenstall, HPRA

Experiences with signal management

Alma Moffett, HPRA

Collecting sales data on antimicrobials

Gavin Ryan, HPRA

Session 1 Q&A

Mary O’Grady, HPRA

Session 2: Developments in the national systems governing the authorisation and monitoring of veterinary medicines

DAFM update on national legislation

Conor O’Mahony, DAFM

Product information updates to QRD v.9 (G.I.18 variations)

Michelle Mulchrone, HPRA

Processing SPCs and labels during the national phase

Sinead Agar, HPRA

Antimicrobial veterinary medicines

David Murphy, HPRA

Session 2 Q&A

Paul McNeill, HPRA

Close and concluding remarks

J. Gabriel Beechinor, HPRA