Veterinary Medicinal Products Clinical Trials in Ireland

This presentation covers the process and regulations surrounding clinical trials and testing of veterinary medicinal products in Ireland. Topics include the application process, HPRA evaluation, fees, scope of legislation, and the purpose of clinical trials. Feedback from a 2016 HPRA survey on clinical trials in Ireland is also discussed, highlighting expertise, proximity to R&D facilities, application speed, and confusion about legislation. The application process involves obtaining an HPRA license before commencing any trial in Ireland, with consultation required with the Department of Agriculture, Food, and the Marine. The timeline for licensing includes steps such as the issuance of an R&V license, evaluation within 40 working days, and addressing queries from the Licensing Committee.

• Veterinary Medicinal Products
• Clinical Trials
• Ireland
• HPRA
• Legislation

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Uploaded on Aug 03, 2024 | 3 Views

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1. Clinical Trials and Testing of Veterinary Medicinal Products in Ireland Jane Lenehan, Scientific Animal Protection Manager (acting) HPRA Veterinary Medicines Information Day 13 June 2018, Hilton Hotel Dublin Airport

2. Todays talk 1. Background 2. Application process 3. HPRA evaluation 4. Fees 5. Conclusion 2 03/08/2024

3. 1. Background

4. Scope Legislation: Directive 2001/82/EU and SI No 786 of 2007 as amended Clinical trial: a study which aims to examine under normal field conditions the safety/efficacy of a veterinary medicinal product (VMP) for the purpose of obtaining a marketing authorisation or a change thereof. 03/08/2024 4

5. Purpose of a clinical trial To demonstrate/substantiate effect of a VMP after administration at recommended dosage To specify: o indications & contraindications according to species/age/breed/sex o directions for use o adverse reactions o safety and tolerance under normal conditions of use 03/08/2024 5

6. HPRA 2016 survey on clinical trials in Ireland Feedback: Expertise in Ireland Proximity to R&D facilities Cost & speed of applications Confusion about legislation 03/08/2024 6

7. 2. Application process

8. Clinical trial application HPRA licence required prior to commencing any trial in Ireland HPRA must consult with the Department of Agriculture, Food and the Marine (DAFM) before granting a licence A copy of application should be sent to DAFM (at time of HPRA application) 03/08/2024 8

9. Timeline R&V Licence issued Evaluation 40 working days Licensing Committee Queries Complete evaluation 03/08/2024 9

10. 3. Clinical trial evaluation

11. Key requirements Detailed trial protocol Trials under veterinary care Informed owner consent Good Clinical Practice (GCP) conditions Control animals Positive control Placebo Untreated control For veterinary field trial use only 03/08/2024 11

12. Key areas of evaluation Trial locations Quantities of test/control medicines to be imported (where no marketing authorisation in place) Withdrawal periods in food- producing species 03/08/2024 12

13. 4. Fees

14. Current Application Fees New trial medicine containing a novel substance 630 New trial medicine containing established ingredient 315 Variation to a current licence 60 14 03/08/2024

15. 5. Conclusion

16. Summary Main evaluation by HPRA with input from DAFM 40 working day timeline Fees 315/ 630 Requirements include GCP, control animals, owner consent, veterinary care, etc. 03/08/2024 16

17. For more information www.hpra.ie/homepage/veterinary /regulatory-information vetinfo@hpra.ie 03/08/2024 17