Post on 13-Jan-2016
Janos PovazsanRhone Vet Kft
Brussels, 2nd December 2008
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.”
•
HUNGARY 2008some figures
Hungarian agriculture has been privatized nearly completely in the last 18 years
Agricultural land has to belong to private persons or to the stateLegal entities, foreigners are not allowed to
posses agricultural landBut legal entities could rent and work the land
Plant production and animal production is mostly divorcedThere are only few farms having corn
production
HUNGARY 2008some figures
Species Population/
Production
Number of large scale
farms
Farm size Income
Cattle 700.000 About 600 100-1500 cowsCow 325.000
Pig 3.700.000 About 600 300-2000 sows, farrow-to-finish
Sow 246.000
Sheep 1.300.000
Horse 58.000
Broiler 140.000.000
Closed to 1000
Up to 300.000
Commercial Layer
6.000.000 About 150 Up to 200.000
Turkey 15.000.000 About 300 Up to 50.000
Duck 18.000.000 About 200 Up to 10.000
Goose 10.000.000 About 200 Up to 5.000
HUNGARY 2008some figures
Dog population: about 1,5-1,6 million
Cat population: no data availableOther pets: no data available
HUNGARY 2008some figures (in 2007)
Companies reporting CEESA:11 billion HUF – equal to 44 million Euro
Companies not reporting CEESA: ?3,8 billion HUF/14 million Euro
to 5,5 million HUF/22 million Euro
Total: 15-20 billion HUF/58-66 million
Euro
HUNGARY 2008some figures
Antimicrobials injectable 1,3 billion
HUF +Antimicrobials oral 1,8 billion
HUF +Biologicals 3,5 billion HUF
+
Antiparasiticides 2,5 billion HUF +
Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’
Representatives2002.: 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
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.”
Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’
Representatives
Simple association conform to the actual Hungarian legislationChairman Board General assembly
Registered office is the office of chairman, H-1119, Budapest, Fehervari u. 89-95.
No employees
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)
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.)
Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’
RepresentativesRegulatory environment of veterinary
productsCentral Agricultural Office
Department of Veterinary Medicine Products
Responsible for registration, control of veterinary medicine production
whole-saler activity control
Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’
RepresentativesMajor issues that the association deals with:Interpretation of EU registration rulesContribution in the preparation of new
legislationLocal language packaging
Implementation of renewals, variations (templates)
PackagingDistribution issuesAdvertisement regulation
Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’
RepresentativesMajor 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)
THANK YOU FOR YOUR ATTENTION!