EU legislation and EudraVigilance Veterinary system

1. EU legislation and EudraVigilance Veterinary system 19 April 2011 - Istanbul - Workshop on EU legislation for veterinary medicinal products Presented by: Jos Olaerts Veterinary Medicines

2. EU pharmacovigilance and reporting of ADRs / AERs • What is monitored? • How frequent / which procedures? • What are the tools? • Future

3. What is monitored? Adverse reaction: A reaction to a veterinary medicinal product which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function. 3

4. What is monitored? Serious adverse reaction: A adverse reaction which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly / birth defect, or which results in permanent or prolonged signs in the animals treated. 4

5. What is monitored? Human adverse reaction: A reaction which is noxious and unintended and which occurs in a human being following exposure to a veterinary medicine. 5

6. What is monitored? • Lack of expected efficacy • Adverse reaction reports related to off-label use • Violations of approved residue limits • Potential environmental problems 6

7. Pharmacovigilance obligations apply to All VMPs authorised in the EU, including those authorised before 1 January 1995 7

8. How frequent / which procedures? Expedited reporting AER (suspected adverse event report) Periodic reporting PSUR (periodic safety update report) 8

9. Expedited reporting • Serious Adverse reaction reports • Human Adverse reactions • 15-day reporting • also for AERs from third countries 9

10. 10

11. Periodic reporting - PSUR • 6-monthly before on the market • 6-6-6-6 monthly after placing on the market • then yearly for the next two years • thereafter at three-yearly intervals 11

12. PSUR - content • All AERS and other information • Sales figures / calculation of incidence • Overall safety information • Risk / Benefit evaluation 12

13. Reporting tools • Expedited reports – Electronic reporting since November 2005 • PSUR reports – paper reporting 13

14. Competent authority responsibilities • Pharmacovigilance system • Monitoring compliance • Initiate assessment of safety concerns • Implement conditions and restrictions • Encourage reporting 14

15. PRODUCTS DATABASE DATA WAREHOUSE C E N T R A L D A T A B A S E EVWEB GATEWAY

16. Minimal requirements of an AE report • Identifiable source (Directive 95/46/EC on protection of personal data) • Animal details • Suspected VMP concerned • Adverse event details 16

19. In the system • 37500 AE Reports from within EEA • 14700 AE Reports from outside EEA • 3700 of total reports relate to human reactions • 32 Authorities – 200 users • 187 organisations – 325 users 19 19

20. 20 EudraVigilance Veterinary – Status Update 20

21. 21 EudraVigilance Veterinary – Status Update 21

22. EVVET 3 • Simplification of report creation • Compatibility with international standards • New tracking facility to exchange and store results from surveillance activities • Address underreporting 22 22

23. 26% 2.6% 2.3% 0.5% 3.7% 1.8% 43% 20% 0.08% 23 23

24. EVVET 3 as reporting & knowledge tool EVVET 3 Veterinarian

25. Authorisation

26. Revision of legislation (under discussion) • Risk based approach. • Simplification of reporting. • Further synchronisation of reporting and analysis. • Focus on one EU pharmacovigilance system. 26 26

27. Other PhV information exchange • Rapid Alert (EUDRANET)(Art. 78 procedures) • Non-Urgent Information System 27 27

28. Reference documents • Regulation (EC) No 726/2004 (Title III Chapter 3) and Directive 2011/82/EC (Title VII) • Volume 9 (b) – Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use. • Guideline on monitoring of compliance with pharmacovigilance regulatory obligations and pharmacovigilance inspections for veterinary medicinal products 28