DECREE ON REQUIREMENTS FOR CORRECT CLINICAL PRACTICE AND CLINICAL TRIALS FOR VETERINARY DRUGS

(Decree of the Ministry of Agriculture of the Slovak Republic No. 57/2003 Coll., stipulating requirements for correct clinical practice and clinical trials for veterinary drugs)

By this decree, the Ministry of Agriculture of the Slovak Republic under Sec. 50 para. 5 of the Act No. 140/1998 Coll. on Drugs and Medical Instruments, on amendment of the Act No. 455/1991 Coll. on Small Trades (Trade Licensing Act) and on amendment and supplement of the Act on Advertisement stipulated requirements for correct clinical practice and clinical trials for veterinary drugs.

This decree stipulates details of the requirements for correct clinical practice for veterinary drugs, which includes the requirements for clinical trials of products determined for veterinary use and of veterinary drugs, monitoring of their safety and adverse effects, as well as requirements for ensuring the quality of clinical trials, multi-centric examinations, manipulation with tested veterinary drugs and information obtained by these trials.

This decree also stipulates details of the rules related to keeping records and storing of documentation on clinical trials, which are also a part of correct clinical practice.

This decree came into force on 1 March 2003.