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1. No risk assessment shall be carried out where the new psychoactive substance is at an advanced stage of assessment within the United Nations system, namely once the World Health Organization’s Expert Committee on Drug Dependence has published its critical review together with a written recommendation, except where there are sufficient data and information available to suggest the need for a risk assessment report at Union level, the reasons for which shall be indicated in the initial report for that substance.

2. No risk assessment shall be carried out where, following an assessment within the United Nations system, it has been decided not to schedule the new psychoactive substance, except where there are sufficient data and information available to suggest the need for a risk assessment report at Union level, the reasons for which shall be indicated in the initial report for that substance.

3. No risk assessment shall be carried out where the new psychoactive substance is an active substance in:

(a) a medicinal product for human use or in a veterinary medicinal product that has obtained a marketing authorisation in accordance with Directive 2001/83/EC, Regulation (EC) No 726/2004 or Regulation (EU) 2019/6;

(b) a medicinal product for human use or in a veterinary medicinal product that is the subject of an application for a marketing authorisation;

(c) a medicinal product for human use or in a veterinary medicinal product whose marketing authorisation has been suspended by the competent authority;

(d) an investigational medicinal product as defined in Article 2, point (d), of Directive 2001/20/EC.