No risk assessment should be conducted on a new psychoactive substance if it is subject to an assessment under international law, or if it is an active substance in a medicinal product or in a veterinary medicinal product, unless there is sufficient scientific evidence, data or studies available at Union level to suggest the need of such assessment.
V zvezi z novo psihoaktivno snovjo se ocena tveganja ne bi smela izvesti, če se v zvezi s to snovjo izvaja ocena na podlagi mednarodnega prava ali če je snov zdravilna učinkovina v zdravilu ali zdravilu za uporabo v veterinarski medicini, razen če so na ravni Unije na voljo zadostni znanstveni dokazi, podatki ali študije, ki kažejo na potrebo po taki oceni.