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

2. 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

3. 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:
TAIEX, Istanbul, April 19th, 2011
Forum, Düsseldorf

4. TAIEX, Istanbul, April 19th, 2011
Forum, Düsseldorf

5. 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, 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, , 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

6. 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
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
Forum, Düsseldorf

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
Forum, Düsseldorf

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)
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

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
Forum, Düsseldorf

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
Forum, Düsseldorf

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
Forum, Düsseldorf

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
Forum, Düsseldorf

15. 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