Jane Lenehan, Scientific Animal Protection Manager (acting) 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
Today’s talk Background Application process HPRA evaluation Fees Conclusion 18/04/2019
1. Background
Legislation: Directive 2001/82/EU and SI No 786 of 2007 as amended 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. 18/04/2019
Purpose of a clinical trial To demonstrate/substantiate effect of a VMP after administration at recommended dosage To specify: indications & contraindications according to species/age/breed/sex directions for use adverse reactions safety and tolerance under normal conditions of use 18/04/2019
HPRA 2016 survey on clinical trials in Ireland Feedback: Expertise in Ireland Proximity to R&D facilities Cost & speed of applications Confusion about legislation 18/04/2019
2. Application process
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) 18/04/2019
Includes permission to import test product Timeline R&V Evaluation Queries Complete evaluation Licensing Committee Licence issued 40 working days Includes permission to import test product DAFM input 18/04/2019
3. Clinical trial evaluation
For veterinary field trial use only 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 18/04/2019
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 18/04/2019
4. Fees
Current Application Fees €630 New trial – medicine containing a novel substance €315 New trial – medicine containing established ingredient €60 Variation to a current licence 18/04/2019
5. Conclusion
Main evaluation by HPRA with input from DAFM 40 working day timeline 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. 18/04/2019
vetinfo@hpra.ie www.hpra.ie/homepage/veterinary/regulatory-information For more information www.hpra.ie/homepage/veterinary/regulatory-information vetinfo@hpra.ie 18/04/2019