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1. Where the Agency, the Commission or a majority of Member States considers that information on a new psychoactive substance collected in one or more Member States and shared with it or them gives rise to concerns that the new psychoactive substance might pose health or social risks at Union level, the Agency shall draw up an initial report on the new psychoactive substance. For the purposes of the first subparagraph, Member States shall inform the Commission and the other Member States of their wish that an initial report be drawn up. Where a majority of Member States has so informed the Commission, the Commission shall instruct the Agency accordingly and shall inform the Member States thereof.

2. An initial report as referred to in paragraph 1 shall contain:

(a) a preliminary indication of the nature, number and scale of incidents showing health and social problems in which the new psychoactive substance might potentially be involved and the patterns of use of the new psychoactive substance;

(b) a preliminary indication of the chemical and physical description of the new psychoactive substance and the methods and precursors used to manufacture or extract it;

(c) a preliminary indication of the pharmacological and toxicological description of the new psychoactive substance;

(d) a preliminary indication of the involvement of criminal groups in the manufacture or distribution of the new psychoactive substance;

(e) information on the human and veterinary medical use of the new psychoactive substance, including as an active substance in a medicinal product for human use or in a veterinary medicinal product;

(f) information on the commercial and industrial use of the new psychoactive substance, the extent of such use, and its use for scientific research and development purposes;

(g) information on whether the new psychoactive substance is subject to any restrictive measures in any Member State;

(h) information on whether the new psychoactive substance is currently or has been under assessment within the United Nations system;

(i) other relevant information, where available.

3. For the purpose of an initial report as referred to in paragraph 1, the Agency shall use the information which is at its disposal.

4. Where the Agency considers it necessary, it shall request the national focal points to provide additional information on a new psychoactive substance. The national focal points shall provide such information within two weeks of receipt of such a request.

5. The Agency shall, without undue delay after it starts drawing up an initial report pursuant to paragraph 1, request the European Medicines Agency to provide information on whether, at Union or national level, 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 of the European Parliament and of the Council , Regulation (EC) No 726/2004 or Regulation (EU) 2019/6 of the European Parliament and of the Council ;

(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 unauthorised medicinal product for human use as referred to in Article 5(1) and (2) of Directive 2001/83/EC or in a veterinary medicinal product prepared extemporaneously in accordance with Article 112(1), point (c), of Regulation (EU) 2019/6;

(e) an investigational medicinal product as defined in Article 2, point (d), of Directive 2001/20/EC of the European Parliament and of the Council . Where information provided under the first subparagraph relates to marketing authorisations granted by Member States, the Member States concerned shall provide the European Medicines Agency with such information upon its request.

6. The Agency shall, without undue delay after it starts drawing up an initial report pursuant to paragraph 1, request Europol to provide information on the involvement of criminal groups in the manufacture, distribution and distribution methods and trafficking of the new psychoactive substance, and on any use of the new psychoactive substance.

7. The Agency shall, without undue delay after it starts drawing up an initial report pursuant to paragraph 1, request the European Chemicals Agency, established by Regulation (EC) No 1907/2006 of the European Parliament and of the Council , and the European Centre for Disease Prevention and Control and the European Food Safety Authority, established by Regulation (EC) No 178/2002 of the European Parliament and of the Council , to provide the information and data at their disposal on the new psychoactive substance.

8. The details of the cooperation between the Agency and the Union agencies referred to in paragraphs 5, 6 and 7 of this Article shall be set out in working arrangements. Such working arrangements shall be concluded in accordance with Article 53(2).

9. The Agency shall respect the conditions on the use of information, which are communicated to the Agency, including conditions on access to documents and information, data security and the protection of confidential data, including the sensitive data and confidential business information of third parties.

10. The Agency shall submit an initial report as referred to in paragraph 1 to the Commission and the Member States within five weeks of making the requests for information referred to in paragraphs 5, 6 and 7.

11. Where the Agency collects information on several new psychoactive substances that it considers to be of a similar chemical structure, it shall submit to the Commission and the Member States an individual initial report as referred to in paragraph 1 for each of those new psychoactive substances, or combined initial reports dealing with several new psychoactive substances, provided that the characteristics of each new psychoactive substance are clearly identified, within six weeks of making the requests for information referred to in paragraphs 5, 6 and 7.