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