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USKVBL

USKVBLThe Institute for State Control of Veterinary Biologicals and Medicines has been founded by the Ministry of Agriculture as the Czech national competent authority in th e field of veterinary medicinal products and related areas, located in Brno. Since the 1st January 1998, the Institute has been established by the Act no. 79/1997 Coll., on Pharmaceuticals as the state administrative authority.

 

 

History of the Institute dates back to 1955, when the "Control Department" was established in the Bioveta Ivanovice na Hané,  State Company. In 1959, the department was renamed and became "State Control Laboratory of Veterinary Biologicals". Since the 1st January 1960, it was included into the State Veterinary Institute (in the structure of the State Veterinary Admiministration) as a "Department of Control of Veterinary Biologicals and Medicines". The Department consisted of four sections located in different parts of Czechoslovakia (Ivanovice na Hané, Brno, Nitra (SK), Terezín)

"The Institute for State Control of Veterinary Biologicals and Medicines" in its current form was established at the time of re-organisation of the veterinary services which was directly subordinated to the State Veterinary Administration (1968). Construction of the new building of the Institute started in 1974 in Brno, Hudcova street, to which all the activities were concentrated in 1977. The building serves to the Institute up to the present day.

The Institute carries out responsibilities in the areas of regulation of veterinary medicines, veterinary non-medicinal products (bordeline products) and veterinary technical devices. The Institute also serves as national reference laboratory for monitoring of prohibited substances residues (in frame of  Regulation (EC) No. 470/2009).

Structure of the Institute reflects its main responsibilities. The Institute is divided into three main sections:

-          Marketing Authorisation Section (responsible for marketing authorization procedures and assessment of veterinary medicinal products and all relevant activities (variations, renewals etc.); approval of non-medicinal veterinary products (borderline products); evidence of veterinary technical devices).

-          Inspection Section (responsible for inspection of manufacturers (veterinary medicinal products and medicated feedingstuffs), wholesalers, pharmacies and retail sellers; in cooperation with Regional Veterinary Administrations for inspections of veterinarians and farmers focused on veterinary medicinal products usage).

-          Section of laboratory control (analyses of veterinary medicinal products; monitoring of prohibited substances residues).