Veterinary preparations, veterinary technical aids

Draft act on veterinary preparations and veterinary technical aids

The draft act on veterinary preparations and veterinary technical aids has been submitted with the aim of laying down the requirements for handling, the conditions of approval for placing on the market and the requirements for manufacture and clinical evaluation of veterinary preparations and veterinary technical aids.

The need to submit this draft act arose from the fact that the requirements for veterinary preparations and veterinary technical aids needed to be laid down. These are prophylactic, therapeutic and protective preparations different from veterinary medicines and used as supporting agents in or after treatment. Previous legislation in Act No 140/1998 on medicinal products and medical devices contained provisions concerning the approval of veterinary preparations and veterinary medical devices (now called veterinary technical aids). Act No 140/1998 was repealed in 2011 through Act No 362/2011 on medicinal products and medical devices and on amendments to certain acts, as amended (hereinafter ‘Act No 362/2011’); the provisions concerning veterinary preparations and veterinary technical aids were not included in Act No 362/2011 since the requirements for handling them fall under a non-harmonised area in the context of European Union law, and it was decided that this area would be regulated in a separate act.