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IMPORTANT PROGRESS ON THE HARMONISATION OF STANDARDS IN VETERINARY DRUGS IN LATIN AMERICA

Following the seminars in Buenos Aires (1992) and Bogota (1993), the Office International des Epizooties recently held a third seminar in Cancun (Mexico), from 7 to 11 April 1997, on the harmonisation of standards and regulations for veterinary drug registration for Latin America. The Organising Committee, under the chairmanship of Professor Emilio Gimeno (Argentina), consisted of international veterinary drug experts, including those from the OIE Collaborating Centre for Veterinary Drugs at Fougères (France).

The Mexican authorities, the world-wide representative body of the animal health industry (COMISA), the Pan American Health Organization (PAHO), the Latin American Federation for the Animal Health Industry (FILASA) and the Institute for International Co-operation in Biologics (IICAB) all supported this seminar, which also benefited from the contributions of many regional and national organisations (1).

The seminar brought together almost a hundred specialists from Latin America, the United States of America and the European Union. They compared the regulations in force in the Americas (Andean and Southern Cone, Central American and North American countries) before debating the many problems associated with the registration and control of veterinary drugs, both in these regions and world-wide: technical bases for chemical and biological control, regional and international regulatory bases, drug residues, industrial issues, pharmacological monitoring, the world market, communication, etc.

Several recommendations were made at the end of the seminar, notably that:

  • the OIE should encourage the establishment of a database of veterinary drugs that are authorised in Latin American countries (technical and administrative information);

  • all participating Latin American countries should commit themselves to working towards the harmonisation of registration criteria for five immunological veterinary drugs (vaccine against classical swine fever, tetanus anatoxin, bovine brucellosis antigen, vaccine against clostridium chauvoei and an inactivated vaccine against Newcastle disease) and for five chemical veterinary drugs (ivermectin, oxytetracycline, enrofloxacine, salinomycine and ocytocine).

 

These recommendations should lead to rapid progress in the harmonisation of regional regulations and procedures for applying them in Latin America. Such harmonisation has become a very important goal for the region in view of the growth and liberalisation of the market for veterinary drugs world-wide.

(1)

INPPAZ: Pan American Institute for Food Protection and Zoonoses
FDA: Food and Drug Administration (United States of America)
JUNAC: Junta del Acuerdo de Cartagena
MERCOSUR: South American Free Trade Association
OIRSA: Organismo Internacional Regional de Sanidad Agropecuaria
VICH: International Co-operation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products

OIE, the world organisation for animal health, was created in 1924 and has its headquarters in Paris. It brings together 145 countries, whose Delegates form an 'International Committee', and is supported by the work of four Specialist Commissions and five Regional Commissions. The OIE's mission is to inform and advise the Veterinary Services of its Member Countries in order to contribute to the eradication of those animal diseases most dangerous for animals or humans, and to establish the health standards for international trade.

 

Contact : Maria Zampaglione

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