ISSN 1977-7868 EMCDDA–Europol Joint Reports EMCDDA–Europol Joint Report on a new psychoactive substance: 5-(2-aminopropyl)indole In accordance with Article 5 of Council Decision 2005/387/JHA on the information exchange, risk assessment and control of new psychoactive substances Legal notice This publication of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) is protected by copyright. The EMCDDA accepts no responsibility or liability for any consequences arising from the use of the data contained in this document. The contents of this publication do not necessarily reflect the official opinions of the EMCDDA’s partners, the EU Member States or any institution or agency of the European Union or European Communities. A great deal of additional information on the European Union is available on the Internet. It can be accessed through the Europa server (http://europa.eu). Europe Direct is a service to help you find answers to your questions about the European Union Freephone number (*): 00 800 6 7 8 9 10 11 (*) Certain mobile telephone operators do not allow access to 00 800 numbers or these calls may be billed. Cataloguing data can be found at the end of this publication. Luxembourg: Publications Office of the European Union, 2013 ISBN 978-92-9168-596-7 doi: 10.2810/85464 © European Monitoring Centre for Drugs and Drug Addiction, 2013 Cais do Sodré, 1249-289 Lisbon, Portugal Tel. +351 211210200 • Fax +351 218131711 [email protected] • www.emcdda.europa.eu © Europol, 2013 Eisenhowerlaan 73, 2517 KK, The Hague, the Netherlands Tel. +31 703025000; Fax +31 703455896 File No: EDOC#645400 Publications: https://www.europol.europa.eu/latest-publications All rights reserved. No part of this publication covered by the copyright thereon may be reproduced or used in any form or by any means — graphic, electronic, or mechanical, including photocopying, recording, taping, or information storage and retrieval systems — without the permission of Europol and the EMCDDA. 5-(2-aminopropyl)indole Contents 1. Introduction 5 2. Information collection process 6 3. Information required by Article 5.2 of the Decision 8 3.1 Chemical and physical description, including the names under which the new psychoactive substance is known — Article 5.2(a) of the Decision 8 3.2 Information on the frequency, circumstances and/or quantities in which a new psychoactive substance is encountered, and information on the means and methods of manufacture of the new psychoactive substance — Article 5.2(b) of the Decision 10 3.3 Information on the involvement of organised crime in the manufacture or trafficking of the new psychoactive substance — Article 5.2(c) of the Decision 14 3.4 A first indication of the risks associated with the new psychoactive substance, including the health and social risks, and of the characteristics of users — Article 5.2(d) of the Decision 15 3.5 Information on whether or not the new substance is currently under assessment, or has been under assessment, by the UN system — Article 5.2(e) of the Decision 20 3.6 The date of notification on the Reporting Form of the new psychoactive substance to the EMCDDA or to Europol — Article 5.2(f) of the Decision 21 3.7 Information on whether or not the new psychoactive substance is already subject to control measures at national level in a Member State — Article 5.2(g) of the Decision 21 3.8 Further information — Article 5.2(h) of the Decision 22 4. Information from the EMA as requested by Article 5.3 of the Decision 25 4.1 Marketing authorisation 25 4.2 Application for a marketing authorisation 25 4.3 Suspended marketing authorisation 25 5. Summary of findings 26 6. Conclusions 28 Annexes 29 Annex 1 — Main information sources 29 Annex 2 — Details of seizures and collected samples of 5-(2-aminopropyl)indole (5-IT) reported to the EMCDDA 31 Annex 3 — Deaths associated with 5-(2-aminopropyl)indole (5-IT) reported to the EMCDDA 35 5-(2-aminopropyl)indole 5 1. Introduction Article 5.1 of Council Decision 2005/387/JHA (1) (hereinafter referred to as the ‘Decision’) stipulates that ‘Where Europol and the EMCDDA, or the Council, acting by a majority of its members, consider that the information provided by the Member State on a new psychoactive substance merits the collection of further information, this information shall be collated and presented by Europol and the EMCDDA in the form of a Joint Report (hereinafter the ‘Joint Report’).’ The Joint Report shall be submitted to the Council, the European Medicines Agency (EMA) (2) and the Commission. At the end of September 2012, the EMCDDA and Europol examined the available information on a new psychoactive substance 5-(2-aminopropyl)indole (commonly known by the abbreviation ‘5-IT’), through a joint assessment based upon the following criteria: 1. the amount of the material seized; 2. evidence of organised crime involvement; 3. evidence of international trafficking; 4. analogy with better-studied compounds; 5. evidence of the potential for further (rapid) spread; and, 6. evidence of cases of serious intoxication or fatalities. The EMCDDA and Europol agreed that the information collected on 5-(2-aminopropyl)indole satisfied criteria 1, 4, 5 and 6. The two organisations therefore concluded that sufficient information had been accumulated to merit the production of a Joint Report on 5-(2-aminopropyl)indole as stipulated by Article 5.1 of the Decision. (1) OJ L 127, 20.5.2005, p. 32. (2) Formerly referred to as the EMEA. 6 EMCDDA–Europol Joint Reports 2. Information collection process In compliance with the provisions of the Decision, on 3 October 2012 the EMCDDA and Europol launched a procedure for the collection of information on 5-(2-aminopropyl)indole, in order to prepare the Joint Report. The information was collected mainly through the Reitox national focal points in the Member States and Croatia, Turkey and Norway as well as the Europol National Units. In addition, the EMA collected information through the Member States’ national competent authorities responsible for human and veterinary medicinal products. The information collection process was largely concluded by 14 November 2012; however, additional information and clarifications from some countries were received up to four weeks after this date. Europol asked the Europol National Units to provide information on: • the level of production of 5-(2-aminopropyl)indole in their country; • the level of distribution of 5-(2-aminopropyl)indole in their country; • the level of trafficking of 5-(2-aminopropyl)indole in their country, both for internal, transit or export purposes; • the number of seizures of 5-(2-aminopropyl)indole in their country, the total amount of the seizures, country of origin, details on the physical forms (including photos); • the role of organised crime, or criminal groups, in the production, distribution and trafficking of 5-(2-aminopropyl)indole in their country; and, • any known aspect of violence and/or money laundering relating to the production and trafficking of 5-(2-aminopropyl)indole. Europol received responses from 22 Member States and Norway. According to Article 5.3 of the Decision, the EMA asked the Member States’ national competent authorities responsible for human and veterinary medicinal products to provide information on whether: • the new psychoactive substance 5-(2-aminopropyl)indole has obtained a marketing authorisation; • the new psychoactive substance 5-(2-aminopropyl)indole is the subject of an application for a marketing authorisation; and, • a marketing authorisation that had been granted in respect of the new psychoactive substance 5-(2-aminopropyl)indole has been suspended. 17 Member States, Iceland and Norway replied to the EMA’s request regarding human and/or veterinary medicinal products. Furthermore, in anticipation of Article 7.3 of the Decision in relation to the manufacturing of medicinal products in the European Union, the EMA also requested whether the new psychoactive substance 5-(2-aminopropyl)indole is used to manufacture a medicinal product: 5-(2-aminopropyl)indole 7 • which has been granted a marketing authorisation; • for which an application has been made for a marketing authorisation; and, • for which a marketing authorisation has been suspended by a competent authority. The same 17 Member States, Iceland and Norway replied to the EMA’s request in this regard. A list of the information sources used to inform the Joint Report are listed in Annex 1, and include data collected by the EMCDDA through: 1. a structured questionnaire from the Reitox national focal points. The EMCDDA received replies from 27 Member States as well as Croatia, Norway and Turkey; 2. a specific information request to the World Health Organization on whether or not 5-(2-aminopropyl)indole is under assessment by the United Nations system (see section 3.5); and, 3. a structured literature review that included a chemical sub-structure search and Internet search. Thus, information included in sections 3.2.1 and 3.3 of the Joint Report was provided by Europol, while the EMCDDA provided information included in sections 3.1, 3.2.2, 3.4, 3.5, 3.6, 3.7, 3.8.1, 3.8.2 and 3.8.3 (partly). The information included in sections 3.4.1 (partly), 3.8.3 (partly), 4.1, 4.2 and 4.3 was provided by the EMA. The summary findings and the conclusion of the Joint Report were prepared and agreed by the two organisations responsible — the EMCDDA and Europol. Further details of the seizures and collected samples (including images where available) reported to the EMCDDA are provided in Annex 2. The details of deaths associated with 5-(2-aminopropyl)indole that have been reported to the EMCDDA are provided in Annex 3.