My HPRA: Register

Veterinary information day 2021 

On 28 October 2021, the HPRA held an information day for marketing authorisation holders and manufacturers of veterinary medicines to provide information on implementing the new requirements coming into effect as part of Regulation 2019/6, the new veterinary regulation.

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

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Session 1: Update on new legislative framework for veterinary medicines

The following presentations are included in the video below: 

  • Opening remarks by the Chair – J.G. Beechinor, HPRA

  • Industry preparedness – John Keogh, APHA 

  • Where we are currently in the EU legislative process - David Murphy, HPRA 

  • Where we are currently in the national legislative process, Peter Collins, DAFM

Additionally, questions from this session have been addressed in Questions & Answers - Session 1. 


Session 2: Changes to marketing authorisation procedures

The following presentations are included in the video below: 

  • Opening remarks by the Chair – David Murphy, HPRA  

  • The EU IT landscape and how it will impact on the future regulation of veterinary medicines in Europe – Sean d'Art, HPRA 

  • Union Product Database and other aspects of preparedness - Elaine Hynes, HPRA 

  • Changes to variation procedures - Mary O'Grady, HPRA

  • Changes to new product authorisation procedures - Rhona McHugh, HPRA

Additionally, questions from this session have been addressed in Questions & Answers - Session 2. 


Session 3: Pharmacovigilance changes, compliance and monitoring

The following presentations are included in the video below: 

  • Opening remarks by the Chair – Paul McNeil, HPRA

  • Signal management - transition from PSURs - what's changing – Hannah Byne, HPRA 

  • The QPPV and Good PhV practice -  what's new - Alma Moffett, HPRA 

  • Ensuring compliance of the PV system: inspections, quality management systems and the PSMF - Peter Twomey, HPRA

Additionally, questions from this session have been addressed in Questions & Answers - Session 3. 


Session 4: Changes to GMP and manufacturing requirements, update on distribution and other aspects

The following presentations are included in the video below: 

  • Opening remarks by the Chair – Aoife Farrell, HPRA

  • Changes to GMP / manufacturing of veterinary medicines and active substance registration requirements – Paul Sexton, HPRA 

  •  Compliance monitoring of veterinary medicines - implications of the new regulations - Kevin O'Donnell, HPRA 

  • Wholesale and distribution of veterinary medicinal products in Ireland - Paul Corkery, DAFM