Animal Health Industry - Pharmacovigilance Requirements

1. Animal Health Industry - Pharmacovigilance Requirements Declan O’ Brien, Managing Director, IFAH-Europe TAIEX, Istanbul, April 19th, 2011

2. Content • IFAH-Europe • References: legal basis, Volume 9B and Guidelines • Main industry obligations • Role of Qualified Person for PharmacoVigilance • PharmacoVigilance System & Inspections • Industry Experience with Inspections • Adverse event reporting • Conclusions TAIEX, Istanbul, April 19th, 2011

3. IFAH-Europe • International Federation for Animal Health-Europe: • The federation representing manufacturers of veterinary medicines, vaccines and other animal health products in Europe • 14 corporate and 20 national association members • Membership covers 90% of the European market for veterinary products • For more information: http://www.ifaheurope.org/ TAIEX, Istanbul, April 19th, 2011

4. TAIEX, Istanbul, April 19th, 2011

5. References • Legal basis: • Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Dir. 2001/82/EC on the Community code relating to veterinary medicinal products (Official Journal L 136, 30.04.2004 p. 58) • Regulation 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Official Journal L 136, 30.04.2004, p. 1) • Commission Eudralex Volume 9B - Note: Vol. 9B remains pending; in the meantime, Vol. 9 (June 2004) remains valid for VMPs • EMA/CVMP guidelines • VICH guidelines TAIEX, Istanbul, April 19th, 2011

6. Status of VICH Guidelines in the EU http://www.vichsec.org/en/topics.htm#6 TAIEX, Istanbul, April 19th, 2011

7. Main industry obligations - 1 • Obligations introduced in 2004 • Detailed Description of the PV system (DDPS) in the Marketing Authorisation (MA) dossier • Risk Management system • Electronic reporting • Existing obligations that received greater emphasis • Increased frequency of submission of periodic safety update reports (PSURs) • Additional channels for the collection of PV data, e.g.: • Reporting suspected transmission of infectious agents via VMPs • Animal owners/breeders encouraged to report via healthcare professionals TAIEX, Istanbul, April 19th, 2011

8. Main industry obligations - 2 • Others • Reporting following suspension or withdrawal of the Marketing Authorisation • Company sponsored post-authorisation safety studies TAIEX, Istanbul, April 19th, 2011

9. Role of the company Qualified Person for PharmacoVigilance (QPPV) • Establishment and maintenance of the company PV system (that can be inspected) • QPPV = contact point for inspection • Reporting: adverse events / PSURs • Company sponsored post-authorisation studies • Continuous overall PV evaluation • Answer additional request from CAs • Delegation of QPPV responsibilities is possible: • Internal delegation / must be well documented and overseen by the QPPV • Contractual arrangements with external organisation TAIEX, Istanbul, April 19th, 2011

10. PharmacoVigilance (PV) system and Inspection • Described in the Commission GL on ‘Monitoring of compliance with PV regulatory obligations and PV inspections for Veterinary Medicinal Products (VMP)’ (March 2007) http://ec.europa.eu/health/documents/eudralex/vol-9/index_en.htm • GLprovides information on: • Content of the Detailed Description of the PV system (Standard Operating Procedures (SOP), training, database, Quality Assurance (QA) auditing...) • Monitoring of compliance by Competent Authorities (CA’s) • Inspection: routine (MS) or targeted (MS or CVMP) • Regulatory action, e.g. education, warning, MA to be amended (variation) or suspended... TAIEX, Istanbul, April 19th, 2011

11. Industry Experience with inspections • Several MSs have now carried out routine inspections since 2006 • Attention brought to archiving and training • IFAH-Europe promotes: • Data exchange between CAs to avoid duplications (role of EMA Inspection sector) • Proportionate approach based on size of the inspected site (human/veterinary and mother company/subsidiary) TAIEX, Istanbul, April 19th, 2011

12. Adverse event reporting - 1 • Industry obligations for expedited (15 day) cases • Report EU cases to the country where the case occurred • Report non-EU (3rd country) cases to EV Vet only • National reporting requirements still apply: • Having to comply with several databases (national and EU) is very challenging for industry • EV Vet (EudraVigilance Vet): central database set-up by EMA: • Contains adverse events reports to all veterinary medicines authorised in the EU, i.e. national, MRP/DCP and CP • Reports received from CAs and industry TAIEX, Istanbul, April 19th, 2011

13. Adverse event reporting - 2 • Industry obligations for Periodic Safety Update Reports (PSUR): • PSUR content: • Focus on scientific evaluation of benefit/risk balance • Line listing containing all cases • Presented in a searchable and sortable format, e.g. pdf or Excel • PSUR format: electronic format encouraged for submission to national Competent Authorities and EMA (pdf sent via Eudralink) • Purely national MAs: English language must be accepted by all Competent Authorities TAIEX, Istanbul, April 19th, 2011

14. Adverse event reporting - 3 • PSURs calendar: • Every 6 months till product on the market • Once on the market: • Every 6 months for first 2 years • Every 12 months for the next 2 years • Every 3 years • Content & timing needs careful consideration when the legislation is reviewed, e.g. only start clock from when product is placed on the market! TAIEX, Istanbul, April 19th, 2011

15. Conclusions • IFAH-Europe is committed to PV • Industry Good Veterinary PhV Best Practice Guide – GVPPG - 2nd edition expected off the press shortly! • Industry has obligations including appointment of a QPPV & a well developed PV system • Adverse event reporting obligations also exist • Content & timing should be reviewed as part of legislative review TAIEX, Istanbul, April 19th, 2011