Information exchange, risk assessment and control of new psychoactive substances
This decision establishes a mechanism for the rapid exchange of information on new psychoactive substances, an assessment of the risks by a scientific committee and a European procedure for placing the notified substances under control. It replaces the joint action on new synthetic drugs of 1997.
Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and control of new psychoactive substances.
The decision establishes a mechanism for a rapid exchange of information on new psychoactive substances. It repeals Joint Action 97/396/JHA, which concerned only new synthetic drugs. The Commission's evaluation of the joint action of 1997, provided for by the European Action Plan to Combat Drugs (2000-04), showed that it should be strengthened and given a new direction.
The decision takes note of the information on the suspected adverse reactions to be notified under the pharmacovigilance system established by Title IX of Directive 2001/83/CE. It also provides for an assessment of the risks which these new psychoactive substances contain, so that supervisory measures may be applied.
It applies to substances not currently listed in any of the schedules to the 1961 United Nations Single Convention on Narcotic Drugs, which may pose a comparable threat to public health as the substances listed in Schedule I or II or IV thereof, and the 1971 United Nations Convention on Psychotropic Substances, which may pose a comparable threat to public health as the substances listed in Schedule I or II or IV thereof.
Each European Union (EU) country shall ensure that its Europol National Unit and its representative in the European Information Network on Drugs and Drug Addiction (Reitox) provide information on the manufacture, traffic and use of new psychoactive substances and of preparations containing new psychoactive substances.
Europol and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) collect the information received from EU countries through a reporting form and communicate this information immediately to each other and to the Europol national units, the EU countries’ representatives in the Reitox network, the European Commission and the European Agency for the Evaluation of Medicinal Products (EMEA).
If necessary, in light of the information supplied by EU countries, Europol and the EMCDDA may submit a joint report containing, among other things, information on the involvement of organised crime in the manufacture or trafficking of the new psychoactive substance, a first indication of the risks associated with the new psychoactive substance, including the health and social risks, and the characteristics of users, the date of notification of the new psychoactive substance to the EMCDDA or to Europol, etc.
The EMEA informs Europol and the EMCDDA whether in the EU or in any EU country:
- the new psychoactive substance has obtained a marketing authorisation;
- the substance is the subject of an application for a marketing authorisation;
- a marketing authorisation that had been granted in respect of the new psychoactive substance has been suspended.
The Council, taking into account the advice of Europol and the EMCDDA, may request an assessment of the health and social risks caused by the use of, the manufacture of, and traffic in, a new psychoactive substance, the involvement of organised crime and the possible consequences of control measures.
The risk assessment report includes the physical and chemical description of the new psychoactive substance, the health and social risks associated with the new psychoactive substance and the chemical precursors that are used for the manufacture of the substance, etc.
No risk assessment is carried out on a new psychoactive substance in the absence of a Europol/EMCDDA joint report or where the new psychoactive substance concerned is at an advanced stage of assessment within the United Nations system, namely once the WHO expert committee on drug dependence has published its critical review together with a written recommendation. No assessment is carried out if the new psychoactive substance is used to manufacture a medicinal product that is the subject of an authorisation or an authorisation request. There is no assessment either if the new psychoactive substance is used to manufacture a medicinal product for which a marketing authorisation has been suspended.
Within six weeks from the date on which it received the risk assessment report, the Commission will present to the Council an initiative to have the new psychoactive substance subjected to control measures. If the Commission deems that it is not necessary to undertake this initiative, it may be presented to the Council by one or more EU countries.
If the Council decides to submit a new psychoactive substance to control measures, EU countries will endeavour to take the necessary measures to submit the new psychotropic drug to control measures and criminal penalties as provided under their legislation by virtue of their obligations under the 1971 United Nations Convention on Psychotropic Substances and the 1961 United Nations Single Convention on Narcotic Drugs.
The EMCDDA and Europol report annually to the European Parliament, the Council and the Commission on the efficacy and achievements of the system created by this decision.
EU countries and the EMEA ensure an appropriate exchange of information between the mechanism set up by means of this decision and the pharmacovigilance systems as defined and established under Title VII of Directive 2001/82/EC and Title IX of Directive 2001/83/EC.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
OJ L 127, 20.5.2005