Veterinary information day - May 2022

On 19 May 2022, the HPRA hosted a webinar for marketing authorisation holders of veterinary medicines regarding developments following the application of Regulation 2019/6, which came into effect on 28 January 2022.

With more than three months since the introduction of the new Regulation, this webinar provided feedback to marketing authorisation holders for veterinary medicines on developments and early experiences on a number of important regulatory topics, including:

• Progress in the implementation of the new EU legislation and regulatory systems

• Changes to HPRA procedures, guidelines and application forms

Presentations and Q&A documents

Presentation slides and Q&A documents are available to download at the links below. 

Union Product Database 

Elaine Hynes 

• Presentation

• Q&A document

Variation applications

Mary O'Grady 

• Presentation 

• Q&A document

Pharmacovigilance and the signal management process

Hannah Byrne 

• Presentation

• Q&A document 

Transitioning marketing authorisations

Rhona McHugh 

• Presentation

• Q&A document 

New process for handling the SPC 

Sinead Agar

Presentation

Revised HPRA policy for mock-ups

Oisin McManus

• Presentation

• Q&A document 

Renewals

Susan Reid

• Presentation 

• Q&A document 

Parallel trade applications 

Denise O'Mahony

• Presentation

• Q&A document  

Closing remarks 

J. Gabriel Beechinor, Director of Veterinary Sciences

Presentation