Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’ Representatives

1. Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’ Representatives Janos Povazsan Rhone Vet Kft Brussels, 2nd December 2008

2. Invitation letter • „We would be delighted if you could make a short presentation in relation to your association describing its structure, membership, secretariat, size of animal health market by major sectors and major issues that the association deals with. It would also be very interesting to learn a little bit about the structure of agriculture in Hungary – number of farmers, farm size, income, numbers of different species of animals, main products produced, exports. Finally, some insight into how the regulatory environment in Hungary is structured would be of interest.”

3. HUNGARY 2008somefigures • Hungarian agriculture has been privatized nearly completely in the last 18 years • Agricultural land has to belong to private persons or to the state • Legal entities, foreigners are not allowed to posses agricultural land • But legal entities could rent and work the land • Plant production and animal production is mostly divorced • There are only few farms having corn production

4. HUNGARY 2008somefigures

5. HUNGARY 2008somefigures • Dog population: about 1,5-1,6 million • Cat population: no data available • Other pets: no data available

6. HUNGARY 2008somefigures (in 2007) • Companiesreporting CEESA: • 11 billion HUF – equalto 44 million Euro • Companiesnotreporting CEESA: ? • 3,8 billion HUF/14 million Euro to 5,5million HUF/22 million Euro • Total: • 15-20 billion HUF/58-66 million Euro

7. HUNGARY 2008somefigures • Antimicrobials injectable 1,3 billion HUF + • Antimicrobials oral 1,8 billion HUF + • Biologicals 3,5 billion HUF + • Antiparasiticides 2,5 billion HUF +

8. Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’ Representatives • 2002.: first attempt to create an association • FEDESA intention to be engaged towards innovation • Creation was not finalized due to different legal status of members • 2005.: creation of association by the REPRESENTATIVES of Bayer, Elanco, Intervet, Merial, Novartis, Pfizer, Schering-Plough • 2006.: REPRESENTATIVES of Ceva-Phylaxia and Virbac have joined

9. Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’ Representatives • „Membership of the Association can be acquired by any research based company manufacturing veterinary products, represented or incorporated in Hungary, with or without foreign participation, that engages primarily in the animal health industry.”

10. Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’ Representatives • Simple association conform to the actual Hungarian legislation • Chairman Board General assembly • Registered office is the office of chairman, • H-1119, Budapest, Fehervari u. 89-95. • No employees

11. Mission of Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’ Representatives Mission of association: save the interests of members, represent and inform them • 3.1.2. strengthen ties between members; • 3.1.3. organise adequate representation of the members in front of authorities and of other professional and commercial bodies; • 3.1.3.1.support the activity of the Veterinary Department of the Ministry of Agriculture • 3.1.4. contribute towards the wider accessibility of the Hungarian veterinarians and animal owners to modern and innovative therapeutic treatment; • 3.1.5. elaborate, accept and respect an ethical codex • 3.1.6. disseminate information, provide education and publish opinion in professional and ethical questions; • 3.1.7, foster a culture of adherence to professional codes of conduct with regard to: • 3.1.7.1.communications with veterinary distributors; • 3.1.7.2.communications with veterinary authorities and animal owners;  • 3.1.7.3.good manufacturing practice (GMP); • 3.1.7.4.good clinical veterinary practice (GVP); • 3.1.7.5.good laboratory practice (GLP)

12. Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’ Representatives Regulatory environment of veterinary products • Principally registration based on • Directive 91/412/EEC (23. June 1991.) • Directive 2001/82/EC (6. November 2001.) • Directive 2004/28/EC (31. March 2004.) • Decret 726/2004/EC (31. March 2004.)

13. Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’ Representatives Regulatoryenvironment of veterinaryproducts • CentralAgricultural Office • Department of VeterinaryMedicine Products • Responsiblefor • registration, • control of veterinarymedicineproduction • whole-saleractivitycontrol

14. Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’ Representatives Major issues that the association deals with: • Interpretation of EU registration rules • Contribution in the preparation of new legislation • Local language packaging • Implementation of renewals, variations (templates) • Packaging • Distribution issues • Advertisement regulation

15. Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’ Representatives Major issues that the association deals with: • IFAH membership • YES • to be member of a European organization • to have some information and influence on global level • to have an opportunity for support • NO • no direct benefit • the mother company is the member • financial aspects (association of REPRESENTATIVES)

16. THANK YOU FOR YOUR ATTENTION!