Risk assessment of new psychoactive substances - EMCDDA - Europa

Convention on Psychotropic Substances, a risk assessment shall be carried outonly if there is significant new information that is relevant in the framework ofthis Decision.3. No risk assessment shall be carried out on a new psychoactive substance if:(a)(b)(c)the new psychoactive substance is used to manufacture a medicinal productwhich has been granted a marketing authorisation; or,the new psychoactive substance is used to manufacture a medicinal productfor which an application has been made for a marketing authorisation or,the new psychoactive substance is used to manufacture a medicinal productfor which a marketing authorisation has been suspended by a competentauthority.Where the new psychoactive substance falls into one of the categories listedunder the first subparagraph, the Commission, on the basis of data collected byEMCDDA and Europol, shall assess with the EMEA the need for further action, inclose cooperation with the EMCDDA and in accordance with the mandate andprocedures of the EMEA.The Commission shall report to the Council on the outcome.Article 8Procedure for bringing specific new psychoactive substances under control1. Within six weeks from the date on which it received the Risk AssessmentReport, the Commission shall present to the Council an initiative to have thenew psychoactive substance subjected to control measures. If the Commissiondeems it is not necessary to present an initiative on submitting the newpsychoactive substance to control measures, within six weeks from the dateon which it received the Risk Assessment Report, the Commission shall presenta report to the Council explaining its views.2. Should the Commission deem it not necessary to present an initiative onsubmitting the new psychoactive substance to control measures, such aninitiative may be presented to the Council by one or more Member States,85