An agency of the European Union

Presented by: Jos OlaertsVeterinary Medicines

EU legislation and EudraVigilance Veterinary system

19 April 2011 - Istanbul - Workshop on EU legislation for veterinary medicinal products

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.

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.

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.

6

What is monitored?

Lack of expected efficacy

Adverse reaction reports related to off-label use

Violations of approved residue limits

Potential environmental problems

7

Pharmacovigilance obligations apply to

All VMPs authorised in the EU, including those authorised before 1 January 1995

8

How frequent / which procedures?

Expedited reporting

AER (suspected adverse event report)

Periodic reporting

PSUR (periodic safety update report)

9

Expedited reporting

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

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

12

PSUR - content

All AERS and other information Sales figures / calculation of incidence Overall safety information Risk / Benefit evaluation

13

Reporting tools

Expedited reports – Electronic reporting since November 2005

PSUR reports – paper reporting

14

Competent authority responsibilities

Pharmacovigilance system Monitoring compliance Initiate assessment of safety concerns Implement conditions and restrictions Encourage reporting

EVWEB

DATAWAREHOUSE

C E N T R A L D A T A B A S E

PRODUCTS DATABASE

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

19 19

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

In the system

EudraVigilance Veterinary – Status Update20 20

EudraVigilance Veterinary – Status Update21 21

22 22

Simplification of report creation

Compatibility with international standards

New tracking facility to exchange and store

results from surveillance activities

Address underreporting

EVVET 3

23 23

0.08%20%

43%

26%

0.5%

2.6%

3.7%

2.3%

1.8%

EVVET 3 as reporting & knowledge tool

EVVET 3 Veterinarian

Authorisation

26 26

Risk based approach.

Simplification of reporting.

Further synchronisation of reporting and

analysis.

Focus on one EU pharmacovigilance system.

Revision of legislation (under discussion)

27 27

Rapid Alert (EUDRANET)

(Art. 78 procedures)

Non-Urgent Information System

Other PhV information exchange

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