![Page 1: Animal Health Industry - Pharmacovigilance Requirements](https://reader035.vdocuments.us/reader035/viewer/2022062308/56812bc5550346895d900b29/html5/thumbnails/1.jpg)
Animal Health Industry - Pharmacovigilance Requirements
Declan O’ Brien,
Managing Director, IFAH-Europe
TAIEX, Istanbul, April 19th, 2011 1
![Page 2: Animal Health Industry - Pharmacovigilance Requirements](https://reader035.vdocuments.us/reader035/viewer/2022062308/56812bc5550346895d900b29/html5/thumbnails/2.jpg)
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 2
![Page 3: Animal Health Industry - Pharmacovigilance Requirements](https://reader035.vdocuments.us/reader035/viewer/2022062308/56812bc5550346895d900b29/html5/thumbnails/3.jpg)
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 3
![Page 4: Animal Health Industry - Pharmacovigilance Requirements](https://reader035.vdocuments.us/reader035/viewer/2022062308/56812bc5550346895d900b29/html5/thumbnails/4.jpg)
TAIEX, Istanbul, April 19th, 2011 4
![Page 5: Animal Health Industry - Pharmacovigilance Requirements](https://reader035.vdocuments.us/reader035/viewer/2022062308/56812bc5550346895d900b29/html5/thumbnails/5.jpg)
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 guidelinesTAIEX, Istanbul, April 19th, 2011 5
![Page 6: Animal Health Industry - Pharmacovigilance Requirements](https://reader035.vdocuments.us/reader035/viewer/2022062308/56812bc5550346895d900b29/html5/thumbnails/6.jpg)
GL # and title VICH step Status in the EU
GL 24: PhV: Management of adverse event reports (AERs)
Step 7Oct. 2007
Implementation pending final GL 35
GL 29: PhV: Management of PSURsStep 7May 2006
Implementation: June 2007
GL 30: PhV: controlled list of terms Step 7 Implementation pending final GL 35
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
Step 7Oct. 2007
Implementation pending final GL 35
Status of VICH Guidelines in the EU
http://www.vichsec.org/en/topics.htm#6 TAIEX, Istanbul, April 19th, 2011 6
![Page 7: Animal Health Industry - Pharmacovigilance Requirements](https://reader035.vdocuments.us/reader035/viewer/2022062308/56812bc5550346895d900b29/html5/thumbnails/7.jpg)
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 7
![Page 8: Animal Health Industry - Pharmacovigilance Requirements](https://reader035.vdocuments.us/reader035/viewer/2022062308/56812bc5550346895d900b29/html5/thumbnails/8.jpg)
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 8
![Page 9: Animal Health Industry - Pharmacovigilance Requirements](https://reader035.vdocuments.us/reader035/viewer/2022062308/56812bc5550346895d900b29/html5/thumbnails/9.jpg)
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 9
![Page 10: Animal Health Industry - Pharmacovigilance Requirements](https://reader035.vdocuments.us/reader035/viewer/2022062308/56812bc5550346895d900b29/html5/thumbnails/10.jpg)
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 10
![Page 11: Animal Health Industry - Pharmacovigilance Requirements](https://reader035.vdocuments.us/reader035/viewer/2022062308/56812bc5550346895d900b29/html5/thumbnails/11.jpg)
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 11
![Page 12: Animal Health Industry - Pharmacovigilance Requirements](https://reader035.vdocuments.us/reader035/viewer/2022062308/56812bc5550346895d900b29/html5/thumbnails/12.jpg)
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 industryTAIEX, Istanbul, April 19th, 2011 12
![Page 13: Animal Health Industry - Pharmacovigilance Requirements](https://reader035.vdocuments.us/reader035/viewer/2022062308/56812bc5550346895d900b29/html5/thumbnails/13.jpg)
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 13
![Page 14: Animal Health Industry - Pharmacovigilance Requirements](https://reader035.vdocuments.us/reader035/viewer/2022062308/56812bc5550346895d900b29/html5/thumbnails/14.jpg)
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 14
![Page 15: Animal Health Industry - Pharmacovigilance Requirements](https://reader035.vdocuments.us/reader035/viewer/2022062308/56812bc5550346895d900b29/html5/thumbnails/15.jpg)
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 15