This Regulation prescribes the principles of good laboratory practice (GLP) for non-clinical tests of substances or preparations (safety studies), the results of which enable the assessment of their effects on people and the environment and are used in the procedures for placing on the market and use, registration, application or communication procedures. GLP principles apply to non-clinical testing of substances contained in: 1. medicines for human use; 2. medicines for veterinary use; 3. cosmetic products; 4. food additives; 5. feed additives; 6. chemicals; 7. Pesticides; 8. Biocides; 9. other. Good laboratory practice is a quality system that refers to the organizational procedures and conditions under which non-clinical health and environmental safety studies are planned, conducted, controlled, recorded, archived and reported.
Slovenia · 2000-04-19