Institute for State Control of Veterinary Biologicals and Medicaments Nitra
|Biovetská 34, 949 01 Nitra
firstname.lastname@example.org, +421 37 6933 527
+421 37 6515506, +421 37 6515507
+421 37 6517915
Basic informationThe Institute conducts the state supervision over veterinary pharmacy as well as control over the production of veterinary medicinal products and veterinary medical devices, the whole distribution of veterinary medicinal products and veterinary medical devices:
- issues production licences and marketing authorizations for veterinary medicinal products
- approves veterinary preparations (disinfection/vitamin/vitamin-mineral/mineral/cosmetic and diagnostic preparations as well as probiotics), and veterinary medical devices,
- provides expert opinions for the registration of veterinary medicinal products and approval of veterinary preparations,
- authorizes clinical trials on veterinary medicinal products,
- maintains a list of authorized veterinary medicinal products, approved veterinary preparations and medical devices,
- orders suspension or withdrawal of veterinary medicinal products or veterinary medical devices from the market,
- exercises control over advertising of medicinal products,
- imposes fines for breach of law.
In compliance with Act Nr. 140/98 Coll. on medicinal products and medical devices as amended, the Institute is authorized for testing and assessment of quality of medicinal products, veterinary immunopreparations, medicated feedingstuffs and vitamin/mineral/cosmetic and diagnostic preparations for animals.
By order of the Slovak Office of Standards, Metrology and Testing, the Institute is an authorized testing body SKTC-121 for conducting conformity assessment in the sphere of veterinary medical devices pursuant to Act Nr. 264/1999 Coll.