2016/0261(COD)

New psychoactive substances: information exchange, early warning system and risk assessment procedure

Procedure completed

2016/0261(COD) New psychoactive substances: information exchange, early warning system and risk assessment procedure
RoleCommitteeRapporteurShadows
Opinion ENVI BUŞOI Cristian-Silviu (EPP)
Lead LIBE BONI Michał (EPP)
Lead committee dossier: LIBE/8/07650
Legal Basis TFEU TFEU 168-p5
Subjects
Links

Activites

  • 2017/11/21 Final act published in Official Journal
  • 2017/11/15 Final act signed
  • 2017/11/15 End of procedure in Parliament
  • #3573
  • 2017/11/10 Council Meeting
  • 2017/11/10 Act adopted by Council after Parliament's 1st reading
  • 2017/10/24 Results of vote in Parliament
    • Results of vote in Parliament
    • T8-0393/2017 summary
  • 2017/10/23 Debate in Parliament
  • 2016/11/30 Committee report tabled for plenary, 1st reading/single reading
    • A8-0359/2016 summary
    • ENVI BUŞOI Cristian-Silviu EPP
    • LIBE LIBE/8/07650 BONI Michał EPP
  • 2016/11/17 Committee decision to open interinstitutional negotiations with report adopted in committee
  • 2016/11/17 Vote in committee, 1st reading/single reading
  • 2016/09/12 Committee referral announced in Parliament, 1st reading/single reading
  • 2016/08/29 Legislative proposal published
    • COM(2016)0547 summary
    • DG {u'url': u'http://ec.europa.eu/info/departments/migration-and-home-affairs_en', u'title': u'Migration and Home Affairs'}, AVRAMOPOULOS Dimitris

Documents

Votes

A8-0359/2016 - Michał Boni - Am 23

2017/10/24
Position Total ALDE ECR EFDD ENF GUE/NGL NI PPE S&D Verts/ALE correctional
For 609 58 64 17 9 35 11 189 176 50 0
Against 19 0 0 13 4 0 2 0 0 0 0
Abstain 29 0 1 5 15 6 2 0 0 0 0
AmendmentsDossier
78 2016/0261(COD) New psychoactive substances: information exchange, early warning system and risk assessment procedure
2016/09/30 LIBE, LIBE 15 amendments...
source: PE-589.454
2016/10/11 ENVI 19 amendments...
source: PE-592.081
2016/10/19 ENVI 23 amendments...
source: PE-592.263
2016/10/28 LIBE 21 amendments...
source: PE-593.828

History

(these mark the time of scraping, not the official date of the change)

2018-09-12
activities/6/docs/0 added
url
http://www.europarl.europa.eu/oeil/popups/sda.do?id=27940&l=en
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Results of vote in Parliament
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Results of vote in Parliament
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Decision by Parliament, 1st reading/single reading
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Results of vote in Parliament
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date
2017-11-21
text
  • PURPOSE: to strengthen the EU's early warning system and risk assessment procedure for new psychoactive substances (NPS).

    LEGISLATIVE ACT: Regulation (EU) 2017/2101 of the European Parliament and of the Council amending Regulation (EC) No 1920/2006 as regards information exchange on, and an early warning system and risk assessment procedure for, new psychoactive substances.

    CONTENT: this Regulation amends Regulation (EC) No 1920/2006 in order to strengthen surveillance and improve the early warning system and to assess the health and social risks associated with new psychoactive substances. The Regulation shall take into account that vulnerable groups, especially young people, are particularly exposed to the risks associated with these new substances.

    The main amendments adopted concern the following points:

    Exchange of information, early warning system and risk assessment: each Member State shall ensure that its national focal point and Europol national units provide the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) with the necessary information they have on the NSPs.

    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.

    Initial report: where the Centre, the Commission or a majority of the Member States considers that information shared on a new psychoactive substance collected in one or more Member States gives rise to concerns that the new psychoactive substance may pose health or social risks at Union level, the Centre shall draw up an initial report on the new psychoactive substance.

    The initial report shall allow the Commission to make an informed decision regarding the launch of the risk assessment procedure. Europol, the European Medicines Agency, the European Centre for Disease Prevention and Control, the European Chemicals Agency and the European Food Safety Authority shall be involved in collecting information for the preparation of the initial reports.

    Risk assessment procedure and report: within two weeks of receipt of an initial report, the Commission may request the Centre to assess the potential risks posed by the new psychoactive substance and to draw up a risk assessment report. The Centre 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. Following the risk assessment procedure, the Commission shall determine whether the new psychoactive substance in question should be included in the definition of ‘drug’ in accordance with the procedure provided for in Council Framework Decision 2004/757/JHA.

    Exclusion from risk assessment: no risk assessment shall be carried out where the new psychoactive substance is at an advanced stage of assessment within the United Nations system.

    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.

    ENTRY INTO FORCE: 22.11.2017.

    APPLICATION: from 23.11.2018.

type
Final act published in Official Journal
docs
procedure/Modified legal basis changed
Old
Rules of Procedure of the European Parliament EP 150
New
Rules of Procedure EP 150
procedure/final added
url
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32017R2101
title
Regulation 2017/2101
procedure/stage_reached changed
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Procedure completed, awaiting publication in Official Journal
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Procedure completed
2017-11-18
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2016-12-16
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2016-11-22
2016-09-29
2016-09-28
2016-09-14

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