Decree No. 290/2003 Coll., On Veterinary Non-Medicinal Products and Veterinary Technical Devices

Main information

Law type

National technical rules and national administrative procedures applicable to goods or goods of a given type

Product type

Veterinary technical devices - equipment, instruments, aids, materials or other objects or products, including accessories, used alone or in combination with the necessary software, which are intended for use in animals for the purposes of prevention, investigation, diagnosis, monitoring, treatment or alleviation disease, injury or disability, replacement or modification of anatomical structure or physiological process, or control of pregnancy, and which do not achieve their main intended function in or on the animal by pharmacological or immunological or metabolic effects, the function of which may be enhanced by such effects ; products used for the marking of animals and which are introduced into the body of an animal for that purpose are also considered to be veterinary technical devices.

Direct link to rule

https://www.zakonyprolidi.cz/cs/2003-290

Scope

The Decree determines quality requirements for veterinary technical devices; requirements for good manufacturing practice in the manufacture of veterinary products; content of the information given on the packaging or in the package leaflet / instructions for use

Main requirements that the business user needs to know about

Obligations regarding - labelling (list of mandatory particulars) - quality requirements (criteria to ensure quality and safety) - good manufacturing practice (criteria for implementing a quality management system)

Good(s) subject to prior authorisation under national law

Yes

Public Administration responsible for accuracy

Institute for State Control of Veterinary Biologicals and Medicines, Hudcova 232 / 56a, Medlánky 621 00 Brno, Czech Republic

Contact details of the national responsible bodies is encouraged

Institute for State Control of Veterinary Biologicals and Medicines, Hudcova 232 / 56a, Medlánky 621 00 Brno, Czech Republic; Phone: +420 541 518 210, +420 541 518 211; E-mail (mailroom): podatelna@uskvbl.cz