Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’ Representatives

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


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 1.300.000Horse 58.000Broiler 140.000.00

0Closed 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


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


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


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.”


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)


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.)


RepresentativesRegulatory environment of veterinary

productsCentral Agricultural Office

Department of Veterinary Medicine Products

Responsible for registration, control of veterinary medicine production

whole-saler activity control


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


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!

Documents

Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’ Representatives