(1)

The particular dangers inherent in the development of psychoactive substances require rapid action by the Member States.

(2)

When new psychoactive substances are not brought within the scope of criminal law in all Member States, problems may arise in cooperation between the judicial authorities and law enforcement agencies of Member States owing to the fact that the offence or offences in question are not punishable under the laws of both the requesting and the requested State.

(3)

The European Union Action Plan on Drugs 2000-2004 provided for the Commission to organise an appropriate assessment of the Joint Action of 16 June 1997 concerning the information exchange, risk assessment and the control of new synthetic drugs (2) (herineafter ‘the Joint Action’) taking into account the external evaluation commissioned by the European Monitoring Centre on Drugs and Drug Addiction (hereinafter ‘the EMCDDA’) of the early warning system. The assessment showed that the Joint Action had fulfilled its expectations. Nevertheless, the outcome of the assessment made it clear that the Joint Action was in need of reinforcement and reorientation. In particular, its main objective, the clarity of its procedures and definitions, the transparency of its operation, and the relevance of its scope had to be redefined. The Communication from the Commission to the European Parliament and the Council on the mid-term evaluation of the EU Action Plan on Drugs (2000-2004) indicated that changes to the legislation would be introduced in order to enhance action against synthetic drugs. The mechanism as established by the Joint Action should therefore be adapted.

(4)

New psychoactive substances can be harmful to health.

(5)

The new psychoactive substances covered by this Decision may include medicinal products as defined in Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to veterinary medicinal products (3) and in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use (4).

(6)

The information exchange under the early warning system, established under the Joint Action, has proved to be a valuable asset to the Member States.

(7)

Nothing in this Decision should prevent Member States from exchanging information, within the European Information Network on Drugs and Drug Addiction (hereinafter ‘the Reitox network’), on emerging trends in new uses of existing psychoactive substances which may pose a potential risk to public health, as well as information on possible public health related measures, in accordance with the mandate and procedures of the EMCDDA.

(8)

No deterioration of either human or veterinary health care as a result of this Decision will be permitted. Substances of established and acknowledged medical value are therefore excluded from control measures based on this Decision. Suitable regulatory and public health related measures should be taken for substances of established and acknowledged medical value that are being misused.

(9)

In addition to what is provided for under the pharmacovigilance systems as defined in Directive 2001/82/EC and in Directive 2001/83/EC, the exchange of information on abused or misused psychoactive substances needs to be reinforced and appropriate cooperation with the European Medicines Agency (hereinafter ‘EMEA’) ensured. The United Nations Commission on Narcotic Drugs (hereinafter ‘CND’) Resolution 46/7 ‘Measures to promote the exchange of information on new patterns of drug use and on psychoactive substances consumed’, provides a useful framework for action by the Member States.

(10)

The introduction of deadlines into every phase of the procedure established by this Decision should guarantee that the instrument can react swiftly and enhances its ability to provide a quick-response mechanism.

(11)

The Scientific Committee of the EMCDDA has a central role in the assessment of the risks associated with a new psychoactive substance, it will for the purpose of this Decision be extended to include experts from the Commission, Europol and the EMEA, and experts from scientific fields not represented, or not sufficiently represented, in the Scientific Committee of the EMCDDA.

(12)

The extended Scientific Committee that assesses the risks associated with new psychoactive substances should remain a concise technical body of experts, capable of assessing effectively all risks associated with a new psychoactive substance. Therefore the extended Scientific Committee should be kept to a manageable size.

(13)

Since the objectives of the proposed action, namely to bring about an exchange of information, a risk-assessment by a scientific committee and an EU-level procedure for bringing notified substances under control, cannot be sufficiently achieved by the Member States and can therefore, by reason of the effects of the envisaged action, be better achieved at European Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality as set out in that Article, this Decision does not go what is beyond what is necessary in order to achieve those objectives

(14)

In conformity with Article 34(2)(c) of the Treaty, measures based upon this Decision can be taken by qualified majority as these measures are necessary to implement this Decision.

(15)

This Decision respects fundamental rights and observes the principles recognised by Article 6 of the Treaty and reflected in the Charter of Fundamental Rights of the European Union,

(a)

the 1961 United Nations Single Convention on Narcotic Drugs, that may pose a comparable threat to public health as the substances listed in Schedule I or II or IV thereof, and

(b)

the 1971 United Nations Convention on Psychotropic Substances, that may pose a comparable threat to public health as the substances listed in Schedule I or II or III or IV thereof.

(a)

‘new psychoactive substance’ means a new narcotic drug or a new psychotropic drug in pure form or in a preparation;

(b)

‘new narcotic drug’ means a substance in pure form or in a preparation, that has not been scheduled under the 1961 United Nations Single Convention on Narcotic Drugs, and that may pose a threat to public health comparable to the substances listed in Schedule I, II or IV;

(c)

‘new psychotropic drug’ means a substance in pure form or in a preparation that has not been scheduled under the 1971 United Nations Convention on Psychotropic Substances, and that may pose a threat to public health comparable to the substances listed in Schedule I, II, III or IV;

(d)

‘marketing authorisation’ means a permission to place a medicinal product on the market, granted by the competent authority of a Member State, as required by Title III of Directive 2001/83/EC (in the case of medicinal products for human use) or Title III of Directive 2001/82/EC (in the case of veterinary medicinal products) or a marketing authorisation granted by the European Commission under Article 3 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (7);

(e)

‘United Nations system’ means the World Health Organisation (WHO), the Commission on Narcotic Drugs (CND) and/or the Economic and Social Committee acting in accordance with their respective responsibilities as described in Article 3 of the 1961 United Nations Single Convention on Narcotic Drugs or in Article 2 of the 1971 United Nations Convention on Psychotropic Substances;

(f)

‘preparation’ means a mixture containing a new psychoactive substance;

(g)

‘Reporting Form’ means a structured form for notification of a new psychoactive substance and/or of a preparation containing a new psychoactive substance agreed between the EMCDDA/Europol and their respective networks in the Member States’ Reitox and the Europol National Units.