EU legislation and EudraVigilance Veterinary system
description
Transcript of EU legislation and EudraVigilance Veterinary system
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
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EU pharmacovigilance and reporting of ADRs / AERs
• What is monitored?• How frequent / which procedures?• What are the tools?• Future
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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.
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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.
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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.
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What is monitored?
Lack of expected efficacy
Adverse reaction reports related to off-label use
Violations of approved residue limits
Potential environmental problems
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Pharmacovigilance obligations apply to
All VMPs authorised in the EU, including those authorised before 1 January 1995
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How frequent / which procedures?
Expedited reporting
AER (suspected adverse event report)
Periodic reporting
PSUR (periodic safety update report)
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Expedited reporting
Serious Adverse reaction reports Human Adverse reactions 15-day reporting also for AERs from third countries
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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
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PSUR - content
All AERS and other information Sales figures / calculation of incidence Overall safety information Risk / Benefit evaluation
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Reporting tools
Expedited reports – Electronic reporting since November 2005
PSUR reports – paper reporting
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Competent authority responsibilities
Pharmacovigilance system Monitoring compliance Initiate assessment of safety concerns Implement conditions and restrictions Encourage reporting
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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
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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
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Simplification of report creation
Compatibility with international standards
New tracking facility to exchange and store
results from surveillance activities
Address underreporting
EVVET 3
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Risk based approach.
Simplification of reporting.
Further synchronisation of reporting and
analysis.
Focus on one EU pharmacovigilance system.
Revision of legislation (under discussion)
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Rapid Alert (EUDRANET)
(Art. 78 procedures)
Non-Urgent Information System
Other PhV information exchange
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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