TAIEX, Istanbul, April 19th, 2011 Animal Health Industry - Pharmacovigilance Requirements Declan O’ Brien, Managing Director, IFAH-Europe TAIEX, Istanbul, April 19th, 2011 Forum, Düsseldorf - 17.02.2009

TAIEX, Istanbul, April 19th, 2011 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 Forum, Düsseldorf - 17.02.2009

TAIEX, Istanbul, April 19th, 2011 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 Forum, Düsseldorf - 17.02.2009

TAIEX, Istanbul, April 19th, 2011 Forum, Düsseldorf - 17.02.2009

TAIEX, Istanbul, April 19th, 2011 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 Forum, Düsseldorf - 17.02.2009

TAIEX, Istanbul, April 19th, 2011 Status of VICH Guidelines in the EU GL # and title VICH step Status in the EU GL 24: PhV: Management of adverse event reports (AERs) Step 7 Oct. 2007 Implementation pending final GL 35 GL 29: PhV: Management of PSURs May 2006 Implementation: June 2007 GL 30: PhV: controlled list of terms GL 35: PhV: Electronic Standards for the Transfer of Regulatory information Step 5 Consultation in the 3 regions closed (15/03/2011) Aim: to provide general framework for implementation of HL7 GL42: PhV: Data Elements for Submission of Adverse Event Reports http://www.vichsec.org/en/topics.htm#6 TAIEX, Istanbul, April 19th, 2011

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 Forum, Düsseldorf - 17.02.2009

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

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 Forum, Düsseldorf - 17.02.2009

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 GL provides 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 Forum, Düsseldorf - 17.02.2009

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 Forum, Düsseldorf - 17.02.2009

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 Forum, Düsseldorf - 17.02.2009

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 Forum, Düsseldorf - 17.02.2009

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 Forum, Düsseldorf - 17.02.2009

TAIEX, Istanbul, April 19th, 2011 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