The exchange of information on, and the early warning system for, new psychoactive substances
1. Each Member State shall ensure that its national focal point and its Europol national unit provide the Agency and Europol, taking into account their respective mandates, with the available information on new psychoactive substances in a timely manner and without undue delay. That information shall be related to the detection and identification, use and patterns of use, manufacture, extraction, distribution and distribution methods, trafficking, and commercial, medical and scientific use of, and potential and identified risks posed by, those substances.
2. The Agency, in cooperation with Europol, shall collect, collate, analyse and assess information on new psychoactive substances. It shall communicate that information in a timely manner to the national focal points, the Europol national units and the Commission with a view to providing them with any information required for the purposes of early warning.
The Agency shall draw up initial reports or combined initial reports pursuant to Article 9 based on the information collected pursuant to the first subparagraph.
Initial report
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 ( 20 ) , Regulation (EC) No 726/2004 or Regulation (EU) 2019/6 of the European Parliament and of the Council ( 21 ) ;
(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 ( 22 ) .
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 ( 23 ) , 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 ( 24 ) , 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.
Risk assessment procedure and report
1. Within two weeks of receipt of an initial report as referred to in Article 9(10), the Commission may request the Agency to assess the potential risks posed by the new psychoactive substance and to draw up a risk assessment report, where there are indications in the initial report to believe that the new psychoactive substance might pose severe public health risks and, where applicable, severe social risks. The risk assessment shall be carried out by the Scientific Committee.
2. Within two weeks of receipt of individual initial reports or a combined initial report as referred to in Article 9(11), the Commission may request the Agency to assess the potential risks posed by several new psychoactive substances with a similar chemical structure and to draw up a combined risk assessment report, where there are indications in the combined initial report to believe that those new psychoactive substances might pose severe public health risks and, where applicable, severe social risks. The combined risk assessment shall be carried out by the Scientific Committee.
3. A risk assessment report or combined risk assessment report shall contain:
(a)
available information on the chemical and physical properties of the new psychoactive substance or substances and the methods and the precursors used to manufacture or extract it or them;
(b)
available information on the pharmacological and toxicological properties of the new psychoactive substance or substances;
(c)
an analysis of the health risks associated with the new psychoactive substance or substances, in particular with respect to its or their acute and chronic toxicity, abuse liability, dependence-producing potential, and physical, mental and behavioural effects;
(d)
an analysis of the social risks associated with the new psychoactive substance or substances, in particular its or their impact on social functioning, public order and criminal activities, and of the involvement of criminal groups in the manufacture, distribution and distribution methods, and trafficking of the new psychoactive substance or substances;
(e)
available information on the extent and patterns of use of the new psychoactive substance or substances and its or their availability and potential for diffusion within the Union;
(f)
available information on the commercial and industrial use of the new psychoactive substance or substances, the extent of such use, as well as its or their use for scientific research and development purposes;
(g)
other relevant information, where available.
4. The Scientific Committee shall carry out a risk assessment in order to assess the risks posed by the new psychoactive substance or group of new psychoactive substances. For each such risk assessment, the Commission, the Agency, Europol and the European Medicines Agency shall each have the right to appoint two observers.
5. The Scientific Committee shall carry out risk assessments as referred to in paragraph 4 on the basis of the available information and of any other relevant scientific evidence. It shall take into account all opinions held by its members. The Agency shall organise the risk assessment procedure, including identifying future information needs and relevant studies.
6. The Agency shall submit the risk assessment report or the combined risk assessment report to the Commission and the Member States within six weeks of receipt of the request from the Commission to draw up a risk assessment report pursuant to paragraph 1 or a combined risk assessment report pursuant to paragraph 2.
7. Upon receipt of a duly reasoned request of the Agency, the Commission may extend the period for completion of the risk assessment or combined risk assessment set out in paragraph 6 to allow for additional research and data collection to take place. Such a request shall contain information on the period of time needed to complete the risk assessment or combined risk assessment.
8. The Agency shall provide timely rapid risk assessments, in accordance with Article 20 of Regulation (EU) 2022/2371 of the European Parliament and of the Council ( 25 ) , in the case of a threat as referred to in Article 2(1), point (b), of that Regulation, where the threat falls under the mandate of the Agency.
Exclusion from risk assessment
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.
Health and security threat assessment and preparedness
1. The Agency shall develop a strategic evidence-based health and security threat assessment capability to identify at an early stage new developments of the drugs phenomenon that have the potential to impact negatively on health, social matters, safety or security in the Union and, by doing so, to help increase the preparedness of the relevant stakeholders to respond to new threats in an effective and timely manner.
2. The Agency may launch a health and security threat assessment on its own initiative based on an internal appraisal of signals arising from routine monitoring, research or other appropriate information sources. The Agency may also launch a health and security threat assessment at the request of the Commission or of a Member State, provided that the criteria set out in paragraph 1 are met.
3. A health and security threat assessment shall consist of a rapid evaluation of existing information and, where necessary, the collection of new information through the Agency’s information networks. The Agency shall develop appropriate scientific rapid assessment methods.
4. Where, following a health and security threat assessment, the Agency draws up a health and security threat assessment report, that report shall describe the identified threat, the current situation based on available evidence and the potential outcomes in the event of no action. The health and security threat assessment report shall set out options for preparedness and response that can be adopted to mitigate and to respond to the threat identified, including, where possible, evidence-based interventions on demand reduction, risk and harm reduction and recovery. The health and security threat assessment report may also contain potential follow-up measures. The Agency shall send the health and security threat assessment report to the Commission and, as appropriate, to the Member States.
5. The Agency shall cooperate closely with Member States, other Union bodies, offices and agencies and international organisations in carrying out a health and security threat assessment by involving them in the assessment as appropriate. Where the potential threat is already subject to an analysis under another Union mechanism, the Agency shall not carry out a health and security threat assessment.
6. With the agreement of the Commission, the Agency shall conduct health and security threat assessments on drug-related threats emerging from outside the Union, which have the potential to impact health, social matters, safety or security within the Union.
7. The Agency shall monitor the evolution of the situation and, where necessary, update the health and security threat assessments accordingly.
European drug alert system
1. The Agency shall set up and manage a rapid European drug alert system, complementing and without prejudice to the relevant national alert systems. The European drug alert system shall be complementary to the early warning system referred to in Article 8.
2. The national focal points, in cooperation with the relevant national competent authorities, shall immediately notify the Agency of any information relating to the appearance of a serious direct or indirect drug-related risk to health, social aspects, safety or security and of any information that might be useful for coordinating a response whenever they become aware of such information, such as:
(a)
the type and origin of the risk;
(b)
the date and place of the event involving the risk;
(c)
the means of exposure, transmission or dissemination;
(d)
analytical and toxicological data;
(e)
identification methods;
(f)
health risks;
(g)
social, safety and security risks;
(h)
health measures implemented or intended to be taken at national level;
(i)
measures other than health measures;
(j)
any other information relevant to the serious risk to health in question.
3. The Agency shall analyse and assess the available information and data on potential serious risks to health and complement it with any scientific and technical information available from the early warning system referred to in Article 8 and other threat assessments undertaken in accordance with Article 12, from other Union bodies, offices and agencies and from international organisations, in particular the World Health Organization. The Agency shall take into account open source information and available information obtained through its data collection tools and from relevant stakeholders, including the scientific community and civil society organisations.
4. Based on the information and data received pursuant to paragraph 3, the Agency shall provide targeted rapid alert risk communications to the relevant national authorities, including the national focal points. The Agency may propose response options in such risk communications. Member States may consider such response options as part of their preparedness planning and national response activities.
5. The national focal points, in cooperation with the relevant national competent authorities, shall inform the Agency of additional information at their disposal in order to enable the Agency to further analyse and assess risks referred to in paragraph 2 and of the actions implemented or measures taken following receipt of the rapid alert risk communications referred to in paragraph 4.
6. The Agency shall cooperate closely with the Commission and the Member States to promote the necessary coherence in the risk communication process.
7. The Agency may open up participation in the European drug alert system to third countries or international organisations. That participation shall be based on reciprocity and shall include confidentiality measures equivalent to those applicable in the Agency.
8. In close cooperation with the relevant national competent authorities, in particular the national focal points, the Agency shall, if needed, develop an alert system to make information on a specific risk available, where appropriate, to people who use or potentially use specific drugs.
9. The Agency shall update its drug alerts, whenever necessary.
Drug precursors
1. The Agency shall assist the Commission in monitoring developments related to the diversion and trafficking of drug precursors and in assessing the need to add to, remove from or change the category of listed scheduled and non-scheduled substances in relation to Regulations (EC) No 273/2004 and (EC) No 111/2005, including in identifying and assessing their licit and illicit uses.
2. The Agency shall prepare, on its own initiative or at the request of the Commission, a threat assessment report on drug precursors.
Network of forensic and toxicological laboratories
1. The Agency shall set up a network of forensic and toxicological laboratories active in forensic and toxicological investigations of drugs and drug-related harm (the ‘network’).
2. The network shall act primarily as a forum for:
(a)
generating data and exchanging information on new developments and trends;
(b)
organising training to enhance the competence of forensic drug and toxicology experts;
(c)
supporting the implementation of quality assurance schemes; and
(d)
supporting the further harmonisation of data collection and analytical methods.
The national focal points shall be informed on a regular basis, at least once a year, about the activities of the network. The national focal points shall have access to the information and data generated by the network.
3. Each Member State shall have the right to appoint to the network, through its representative in the Management Board, up to three laboratories specialising in forensic analysis, toxicology or other relevant fields related to drugs to act as national representative laboratories. The Agency may select additional laboratories or experts particularly active in forensic and toxicological investigations of drugs and drug-related harm for specific projects.
4. The Joint Research Centre of the Commission shall be a member of the network and represent the Commission in the network.
5. The network shall cooperate closely with existing networks and organisations active in the same areas as the network and shall take their work into account in order to avoid overlaps. The Reitox network shall be informed regularly, and at least once a year, about the work of the network.
6. The Agency shall chair the network and convene at least one meeting a year. The network may decide to create working groups, which may be chaired by members of the network.
7. The network shall enable the Agency to have access to forensic and toxicological data, generated or collected by laboratories of the network, including, where necessary, for the analysis of new psychoactive substances.
8. The Agency shall identify and finance specific projects to further the work of the network, as appropriate and based on clear and transparent rules and procedures. The Agency shall establish those rules and procedures prior to identifying such projects.
9. The Agency shall create a database to store, analyse and make available the information and data collected or generated by the network, in accordance with the relevant provisions of this Regulation, including Article 6(8) and Article 49.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
