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Document 02006R1920-20181123
Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction (recast)
Consolidated text: Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction (recast)
Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction (recast)
No longer in force
02006R1920 — EN — 23.11.2018 — 001.001
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REGULATION (EC) No 1920/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction (recast) (OJ L 376 27.12.2006, p. 1) |
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REGULATION (EU) 2017/2101 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 November 2017 |
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21.11.2017 |
REGULATION (EC) No 1920/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 12 December 2006
on the European Monitoring Centre for Drugs and Drug Addiction (recast)
Article 1
Objective
Article 2
Tasks
In order to achieve the objective set out in Article 1, the Centre shall perform the following tasks within its areas of activity:
Collection and analysis of existing data
collecting, registering and analysing information, including data resulting from research, communicated by Member States and data emanating from Community, non-governmental national sources and competent international organisations, including the European Police Office (Europol); providing information on best practices in the Member States and facilitating the exchange of such practices among them; this collection, registration, analysis and information work shall also cover data on emerging trends in poly-drug use, including the combined use of licit and illicit psychoactive substances;
carrying out surveys, preparatory studies and feasibility studies, together with any pilot projects necessary to accomplish its tasks; organising meetings of experts and, whenever necessary, setting up ad hoc working parties for the purpose; setting up and making available open scientific documentation resources and assisting in the promotion of information activities;
providing an organisational and technical system capable of supplying information on similar or complementary programmes or action pursued by the Member States;
establishing and coordinating, in consultation and in cooperation with the competent authorities and organisations in the Member States, the network referred to in Article 5;
facilitating exchanges of information between decision-makers, researchers, specialists and those involved in drugs-related issues in governmental and non-governmental organisations;
Improvement of data-comparison methods
ensuring improved comparability, objectivity and reliability of data at European level by establishing indicators and common criteria of a non-binding nature, compliance with which may be recommended by the Centre, with a view to ensuring greater uniformity of the measurement methods used by the Member States and the Community; in particular, the Centre shall develop tools and instruments to help Member States to monitor and evaluate their national policies and the Commission to monitor and evaluate Union policies;
facilitating and structuring information exchange in terms of both quality and quantity (databases);
Dissemination of data
making the information produced by it available to the Community, the Member States and competent organisations;
ensuring wide dissemination of work done in each Member State and by the Community itself, and, where appropriate, by third countries or international organisations;
ensuring wide dissemination of reliable non-confidential data, publishing on the basis of data which it gathers, a yearly report on the state of the drugs problem, including data on emerging trends;
Cooperation with European and international bodies and organisations and with third countries
contributing to improving coordination between national and Community action in its areas of activity;
without prejudice to Member States' obligations with regard to transmission of information under the provisions of the United Nations Conventions on drugs, promoting the incorporation of data on drugs and drug addiction gathered in the Member States or emanating from the Community into international monitoring and drug-control programmes, particularly those established by the UN and its specialised agencies;
cooperating actively with Europol to attain maximum efficiency in monitoring the drugs problem;
cooperating actively with the organisations and bodies referred to in Article 20;
transferring, at the request of the Commission and with the approval of the Management Board referred to in Article 9, its know-how to certain third countries such as candidate countries or the countries of the western Balkans and assist in the creation and strengthening of structural links with the network referred to in Article 5 and the setting-up and consolidation of the national focal points referred to in that Article;
Information obligations
In principle, the Centre shall, if it identifies new developments and changing trends, inform the competent authorities of the Member States thereof;
Exchange of information on, early warning system for, and risk assessment of, new psychoactive substances
collecting, collating, analysing and assessing the available information from the national focal points referred to in Article 5 and the Europol national units on new psychoactive substances as defined in point 4 of Article 1 of Council Framework Decision 2004/757/JHA ( 1 ) and communicating that information to the national focal points and the Europol national units as well as to the Commission without undue delay;
drawing up the initial report or combined initial report in accordance with Article 5b;
organising the risk assessment procedure in accordance with Articles 5c and 5d;
monitoring, in cooperation with Europol and with the support of the national focal points referred to in Article 5 and the Europol national units, all new psychoactive substances that have been reported by Member States.
Article 3
Priority areas of activity
The objective and tasks of the Centre, as set out in Articles 1 and 2, shall be implemented following the order of priorities indicated in Annex I.
Article 4
Working method
Article 5
European Information Network on Drugs and Drug Addiction (Reitox)
The national focal points shall form an interface between the participating countries and the Centre. They shall contribute to the establishment of key indicators and data, including guidelines for their implementation with a view to obtaining reliable and comparable information at European Union level. They shall collect and analyse in an objective manner at national level, bringing together experience from different sectors – health, justice, law enforcement – in cooperation with experts and national organisations active in the field of drugs policy, all relevant information on drugs and drug addiction, as well as on policies and solutions applied. In particular, they shall provide data for the five epidemiological indicators specified by the Centre.
▼M1 —————
The national focal points may also provide the Centre with information on new trends in the use of existing psychoactive substances and/or new combinations of psychoactive substances which pose a potential risk to public health as well as information on possible measures related to public health.
Article 5a
Information exchange on, and early warning system for, new psychoactive substances
Each Member State shall ensure that its national focal point, as referred to in Article 5, and its Europol national unit provide the Centre and Europol, taking into account their respective mandates, with the available information on new psychoactive substances in a timely manner and without undue delay. The 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.
The Centre, in cooperation with Europol, shall collect, collate, analyse and assess the information and communicate it in a timely manner to the national focal points and the Europol national units as well as to the Commission with a view to providing them with any information required for the purposes of early warning and for the purposes of allowing the Centre to draw up the initial report or the combined initial report pursuant to Article 5b.
Article 5b
Initial report
For the purpose of this paragraph, Member States shall inform the Commission and other Member States of their wish that an initial report be drawn up. Where the majority of Member States is reached, the Commission shall instruct the Centre accordingly and shall inform the Member States thereof.
The initial report shall contain a first indication of:
the nature, number and scale of incidents showing health and social problems in which the new psychoactive substance may potentially be involved, and the patterns of use of the new psychoactive substance;
the chemical and physical description of the new psychoactive substance and the methods and precursors used for its manufacture or extraction;
the pharmacological and toxicological description of the new psychoactive substance;
the involvement of criminal groups in the manufacture or distribution of the new psychoactive substance.
The initial report shall also contain:
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;
information on the commercial and industrial use of the new psychoactive substance, the extent of such use, as well as its use for scientific research and development purposes;
information on whether the new psychoactive substance is subject to any restrictive measures in the Member States;
information on whether the new psychoactive substance is currently or has been under assessment within the system established by the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, and the 1971 Convention on Psychotropic Substances (‘United Nations system’);
other relevant information, where available.
The Centre shall, without undue delay, 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 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 ( 2 ), Directive 2001/82/EC of the European Parliament and of the Council ( 3 ) or Regulation (EC) No 726/2004 of the European Parliament and of the Council ( 4 );
a medicinal product for human use or in a veterinary medicinal product that is the subject of an application for a marketing authorisation;
a medicinal product for human use or in a veterinary medicinal product whose marketing authorisation has been suspended by the competent authority;
an unauthorised medicinal product for human use in accordance with Article 5 of Directive 2001/83/EC or in a veterinary medicinal product prepared extemporaneously by a person authorised to do so under national law in accordance with point (c) of Article 10(1) of Directive 2001/82/EC;
an investigational medicinal product as defined in point (d) of Article 2 of Directive 2001/20/EC of the European Parliament and of the Council ( 5 ).
Where the information relates to marketing authorisations granted by Member States, the Member States concerned shall provide the European Medicines Agency with such information upon its request.
Article 5c
Risk assessment procedure and report
The risk assessment report or combined risk assessment report shall contain:
available information on the chemical and physical properties of the new psychoactive substance and the methods and the precursors used for its manufacture or extraction;
available information on the pharmacological and toxicological properties of the new psychoactive substance;
an analysis of the health risks associated with the new psychoactive substance, in particular with respect to its acute and chronic toxicity, abuse liability, dependence-producing potential, and physical, mental and behavioural effects;
an analysis of the social risks associated with the new psychoactive substance – in particular its impact on social functioning, public order and criminal activities, and the involvement of criminal groups in the manufacture, distribution and distribution methods, and trafficking of the new psychoactive substance;
available information on the extent and patterns of use of the new psychoactive substance, its availability and potential for diffusion within the Union;
available information on the commercial and industrial use of the new psychoactive substance, the extent of such use, as well as its use for scientific research and development purposes;
other relevant information, where available.
The Commission, the Centre, Europol and the European Medicines Agency shall each have the right to nominate two observers.
Article 5d
Exclusion from risk assessment
No risk assessment shall be carried out where the new psychoactive substance is an active substance in:
a medicinal product for human use or in a veterinary medicinal product that has obtained a marketing authorisation;
a medicinal product for human use or in a veterinary medicinal product that is the subject of an application for a marketing authorisation;
a medicinal product for human use or in a veterinary medicinal product whose marketing authorisation has been suspended by the competent authority;
an investigational medicinal product as defined in point (d) of Article 2 of Directive 2001/20/EC.
Article 6
Protection and confidentiality of data
Data on drugs and drug addiction provided to or by the Centre may be published subject to compliance with Community and national rules on the dissemination and confidentiality of information. Personal data may not be published or made accessible to the public.
Member States and the national focal points shall be under no obligation to provide information classified as confidential under their national law.
Article 7
Access to documents
Article 8
Legal capacity and location
Article 9
Management Board
The Centre shall have a Management Board consisting of one representative from each Member State, two representatives from the Commission, two independent experts particularly knowledgeable in the field of drugs designated by the European Parliament and one representative from each country which has concluded an agreement pursuant to Article 21.
Each member of the Management Board shall have one vote, except for the representatives of the countries which have concluded agreements pursuant to Article 21, who shall not have the right to vote.
The decisions of the Management Board shall be taken by a two-thirds majority of the members with a right to vote, except in the cases provided for in paragraph 6 of this Article and in Article 20.
Each member of the Management Board may be assisted or represented by a substitute. Where a full member who has the right to vote is absent, his or her substitute may exercise that right.
The Management Board may invite as non-voting observers representatives of international organisations with which the Centre cooperates in accordance with Article 20.
The Chairperson and Vice-Chairperson of the Management Board shall be elected from amongst and by its members for a three-year period. Their terms of office shall be renewable once.
The Chairperson and Vice-Chairperson shall have the right to take part in the voting.
The Management Board shall draw up its own rules of procedure.
Article 10
Executive Committee
Article 11
Director
The Director shall be responsible for:
preparing and implementing the decisions and programmes adopted by the Management Board,
day-to-day administration,
preparing the Centre's work programmes,
the preparation of the draft estimate of the Centre's revenue and expenditure and the implementation of the budget,
the preparation and publication of the reports provided for in this Regulation,
managing all staff-related matters, and in particular exercising the powers which are devolved on the appointing authority,
defining the Centre's organisational structure and submitting it to the Management Board for approval,
the performance of the tasks referred to in Articles 1 and 2,
carrying out a regular assessment of the Centre's work.
Article 12
Hearing of the Director and of the Chairperson of the Management Board before the European Parliament
Each year the Director shall submit to the European Parliament the general report on the Centre's activities. The European Parliament may also ask for a hearing with the Director and the Chairperson of the Management Board on any subject related to the Centre's activities.
Article 13
Scientific Committee
The Management Board and the Director shall be assisted by a Scientific Committee which shall deliver an opinion where provided for in this Regulation on any scientific matter concerning the Centre's activities which the Management Board or the Director may submit to it.
The opinions of the Scientific Committee shall be published.
The Scientific Committee shall consist of at most fifteen well-known scientists appointed in view of their scientific excellence and their independence by the Management Board, following the publication of a call for expressions of interest in the Official Journal of the European Union. The selection procedure shall ensure that the specialist fields of the members of the Scientific Committee cover the most relevant scientific fields linked to the problems of drugs and drug addiction.
The members of the Scientific Committee shall be appointed in a personal capacity and shall give their opinions completely independently of the Member States and the Community Institutions.
The Scientific Committee shall take into account the various positions expressed in national expert opinions, if available, before delivering any opinion.
For the purpose of assessing the risks posed by the new psychoactive substance or group of new psychoactive substances, the Scientific Committee may be extended following the procedure laid down in Article 5c(4).
Article 14
Drawing up of the budget
The Centre's expenditure shall include:
staff remuneration, administrative and infrastructure expenses, and operating costs;
expenditure in support of the Reitox focal points.
The Management Board shall, as soon as possible, notify the budgetary authority of its intention to implement any project which may have significant financial implications for the funding of the budget, in particular any projects relating to property such as the rental or purchase of buildings. It shall inform the Commission thereof.
Where a branch of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Management Board within a period of six weeks from the date of notification of the project.
Article 15
Implementation of the budget
The Director shall, by 1 July following each financial year, forward the final accounts to the European Parliament, the Council, the Commission and the Court of Auditors, together with the Management Board's opinion.
The final accounts shall be published.
Article 16
Combating fraud
Article 17
Privileges and immunities
The Protocol on the Privileges and Immunities of the European Communities shall apply to the Centre.
Article 18
Staff Regulations
The Staff Regulations of officials of the European Communities and the Conditions of Employment of other servants of the European Communities and the rules adopted jointly by the Community Institutions for the purpose of applying those Staff Regulations and Conditions of Employment shall apply to the staff of the Centre.
Where it engages staff from third countries following the conclusion of the agreements referred to in Article 21, the Centre shall, in any event, comply with the Staff Regulations and Conditions of Employment referred to in paragraph 1 of this Article.
The Centre shall exercise in respect of its staff the powers devolved to the appointing authority.
The Management Board shall, in agreement with the Commission, adopt the appropriate implementing rules in accordance with the Staff Regulations, Article 110, and the Conditions of Employment referred to in paragraph 1.
The Management Board may adopt provisions to allow national experts from other Member States to be employed on secondment at the Centre.
Article 19
Liability
Article 20
Cooperation with other organisations and bodies
Without prejudice to relations which the Commission may maintain pursuant to Article 302 of the Treaty, the Centre shall actively seek to cooperate with international organisations and other, particularly European, governmental and non-governmental bodies competent in the sector of drugs.
Such cooperation shall be based on working arrangements concluded with the organisations and bodies referred to in the first paragraph. Those arrangements shall be adopted by the Management Board on the basis of a draft submitted by the Director and after the Commission has delivered an opinion. Where the Commission expresses its disagreement with these arrangements, the Management Board shall adopt them by a three-fourths majority of the members with a right to vote.
Article 21
Participation of third countries
The Centre shall be open to the participation of any third country that shares the interest of the Community and of its Member States in the Centre's objectives and work, on the basis of agreements entered into between such third countries and the Community on the basis of Article 300 of the Treaty.
Article 22
Jurisdiction of the Court of Justice
The Court of Justice shall have jurisdiction in actions brought against the Centre under Article 230 of the Treaty.
Article 23
Evaluation report
The Commission shall initiate an external evaluation of the Centre every six years to coincide with the completion of two of the Centre's three-year work programmes. Such evaluations shall also include the Reitox system. The Commission shall forward the evaluation report to the European Parliament, the Council and the Management Board.
In that context, the Commission shall, if appropriate, present a proposal for revision of the provisions of this Regulation in the light of developments in respect of regulatory agencies, in accordance with the procedure laid down in Article 251 of the Treaty.
Article 24
Repeal
Regulation (EEC) No 302/93 is hereby repealed.
References made to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex III.
Article 25
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
The work of the Centre shall be carried out with due regard to the respective powers of the Community and its Member States in the area of drugs, as those powers are defined by the Treaty. It shall cover the various facets of the drugs and drug addiction phenomenon, and the solutions applied. In doing so, the Centre shall be guided by the Drugs Strategies and Action Plans adopted by the European Union.
The Centre shall focus on the following priority areas:
monitoring the state of the drugs problem, in particular using epidemiological or other indicators, and monitoring emerging trends, in particular those involving poly-drug use;
monitoring the solutions applied to drug-related problems; providing information on best practices in the Member States and facilitating the exchange of such practices among them;
assessing the risks of new psychoactive substances and maintaining a rapid information system with regard to their use and also regarding new methods of using existing psychoactive substances;
developing tools and instruments to help Member States to monitor and evaluate their national policies and the Commission to monitor and evaluate European Union policies.
The Commission shall make available to the Centre, for dissemination, the information and statistical data which it possesses pursuant to its powers.
ANNEX II
REPEALED REGULATION AND SUCCESSIVE AMENDMENTS
Council Regulation (EEC) No 302/93 |
OJ L 36, 12.2.1993, p. 1. |
Council Regulation (EC) No 3294/94 |
OJ L 341, 30.12.1994, p. 7. |
Council Regulation (EC) No 2220/2000 |
OJ L 253, 7.10.2000, p. 1. |
Council Regulation (EC) No 1651/2003 |
OJ L 245, 29.9.2003, p. 30. |
ANNEX III
CORRELATION TABLE
Council Regulation (EEC) No 302/93 |
This Regulation |
Article 1 |
Article 1 |
— |
Article 1(3), second and third sentences |
Article 2(A), sub-heading |
Article 2(a), sub-heading |
Article 2(A)(1) |
Article 2(a)(i), first phrase |
— |
Article 2(a)(i), second and third phrases |
Article 2(A)(2) to (5) |
Article 2(a)(ii) to (v) |
Article 2(B), sub-heading |
Article 2(b), sub-heading |
Article 2(B)(6), first phrase |
Article 2(b)(i), first phrase |
— |
Article 2(b)(i), second phrase |
Article 2(B)(7) |
Article 2(b)(ii) |
Article 2(C), sub-heading |
Article 2(c), sub-heading |
Article 2(C)(8) to (10) |
Article 2(c)(i) to (iii) |
Article 2(D), sub-heading |
Article 2(d), sub-heading |
Article 2(D)(11) to (13) |
Article 2(d)(i), (ii) and (iv) |
— |
Article 2(d)(iii) and (v) |
— |
Article 2(e) |
Article 3 |
Article 4 |
Article 4 |
Article 3 |
Article 5(1) |
Article 5(1) |
— |
Article 5(2), (3) and (4) |
Article 5(4) |
Article 5(5) |
Article 6(2) and (3) |
Article 6(1) |
— |
Article 6(2) |
Article 6a |
Article 7 |
Article 7 |
Article 8 |
— |
Article 8, heading |
— |
Article 8 (2) |
Article 8(1) |
Article 9(1), first, fourth and fifth subparagraphs |
Article 8(2) |
Article 9(1), second and third subparagraphs; Article 9(2); Article 9(3), second sentence |
— |
Article 9(3), first and third sentences |
Article 8(3) |
Article 9(4) |
Article 8(4) |
Article 9(5), first and third sentences |
— |
Article 9(5), second sentence |
— |
Article 9(6) |
Article 8(5) and (6) |
Article 9(7) and (8) |
— |
Article 10 |
Article 9(1), first subparagraph |
Article 11(1) |
— |
Article 11(2) |
Article 9(1), second subparagraph |
Article 11(3) |
Article 9(1), second subparagraph, first to sixth indent |
Article 11(3)(a) to (f), first phrase |
— |
Article 11(3)(f), second phrase |
— |
Article 11(3)(g) |
Article 9(1), second subparagraph, seventh indent |
Article 11(3)(h) |
— |
Article 11(3)(i) |
Article 9(2) and (3) |
Article 11(4) and (5) |
— |
Article 12 |
Article 10(1) |
Article 13(1) |
Article 10(2) |
Article 13(2), first and fourth subparagraphs |
— |
Article 13(2), second and third subparagraphs |
Article 10(3), (4) and (5) |
Article 13(3) and (4) |
Article 11(1) to (6) |
Article 14(1) to (5) |
Article 11(7) to (10) |
Article 14(6) to (9) |
Article 11a(1) to (5) |
Article 15(1) to (5) |
Article 11a(6) and (7) |
Article 15(6) |
Article 11a(8) to (11) |
Article 15(7) to (10) |
— |
Article 16 |
Article 12 |
Article 20 |
— |
Article 20, second subparagraph |
Article 13(1) |
Article 21 |
Article 13(2) |
— |
Article 14 |
Article 17 |
Article 15 |
Article 18, first, third and fourth subparagraphs |
— |
Article 18, second and fifth subparagraphs |
Article 16 |
Article 19 |
Article 17 |
Article 22 |
Article 18 |
Article 23, first subparagraph, first and third sentences |
— |
Article 23, first subparagraph, second sentence |
— |
Article 23, second subparagraph |
— |
Article 24 |
Article 19 |
Article 25 |
Annex, paragraph A, first subparagraph |
Annex I, paragraph A, first subparagraph, first sentence |
— |
Annex I, paragraph A, first subparagraph, second and third sentences |
— |
Annex I, paragraph A, second subparagraph, points (1) to (4) |
Annex, paragraph A, second subparagraph, points 1 to 5 |
— |
Annex, paragraph B |
Annex I, paragraph B |
Annex, paragraph C |
— |
— |
Annex II |
— |
Annex III |
( 1 ) Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (OJ L 335, 11.11.2004, p. 8).
( 2 ) 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 (OJ L 311, 28.11.2001, p. 67).
( 3 ) 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 (OJ L 311, 28.11.2001, p. 1).
( 4 ) 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 (OJ L 136, 30.4.2004, p. 1).
( 5 ) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
( 6 ) OJ L 248, 16.9.2002, p. 1.
( 7 ) OJ L 357, 31.12.2002, p. 72.