Risk assessment of new psychoactive substances - EMCDDA - Europa

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Risk assessment of new psychoactive substances: operating guidelinespreferably not later than six weeks from the date on which the Commissionpresented its report to the Council.3. The Council shall decide, by qualified majority and acting on an initiativepresented pursuant to paragraph 1 or 2, on the basis of Article 34(2)(c)of the Treaty, whether to submit the new psychoactive substance to controlmeasures.Article 9Control measures taken by Member States1. If the Council decides to submit a new psychoactive substance to controlmeasures, Member States shall endeavour to take, as soon as possible, butno later than one year from the date of that decision, the necessary measuresin accordance with their national law to submit:(a)(b)the new psychotropic drug to control measures and criminal penalties asprovided under their legislation by virtue of their obligations under the 1971United Nations Convention on Psychotropic Substances;the new narcotic drug to control measures and criminal penalties as providedunder their legislation by virtue of their obligations under the 1961 UnitedNations Single Convention on Narcotic Drugs.2. Member States shall report the measures taken to both the Council and theCommission as soon as possible after the relevant decision has been taken.Thereafter this information shall be communicated to the EMCDDA, Europol,the EMEA, and the European Parliament.3. Nothing in this Decision shall prevent a Member State from maintaining orintroducing on its territory any national control measure it deems appropriateonce a new psychoactive substance has been identified by a Member State.Article 10Annual reportThe EMCDDA and Europol shall report annually to the European Parliament, theCouncil and the Commission on the implementation of this Decision. The reportwill take into account all aspects required for an assessment of the efficacy and86
achievements of the system created by this Decision. The Report shall, in particular,include experience relating to coordination between the system set out in thisDecision and the pharmacovigilance system.Article 11Pharmacovigilance systemMember States and the EMEA shall ensure an appropriate exchange ofinformation between the mechanism set up by means of this Decision and thepharmacovigilance systems as defined and established under Title VII of Directive2001/82/EC and Title IX of Directive 2001/83/EC.Article 12RepealThe Joint Action on New Synthetic Drugs of 16 June 1997 is hereby repealed.Decisions taken by the Council based on Article 5 of that Joint Action shallcontinue to be legally valid.Article 13Publication and taking effectThis Decision shall take effect on the day following that of its publication in theOfficial Journal of the European Union.Done at Brussels, 10 May 2005.For the CouncilThe PresidentJ. Krecké87
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ContentsAcknowledgements 5Foreword
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IntroductionThese guidelines are a
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Chapter 1Legal basis and scope1.1 L
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factors that would warrant such act
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Chapter 2General considerations for
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2.6 Quality of dataIn the final eva
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Chapter 3A conceptual framework for
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(family, neighbourhood and communit
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Chapter 4Headings for the Risk Asse
Page 37 and 38: Descriptive elements• Name of the
Page 39 and 40: (c) Social risksSome public health
Page 41 and 42: • Evidence that the same groups o
Page 43: Elements for examining the conseque
Page 47: Chapter 6ConclusionThe Risk Assessm
Page 51 and 52: Annex ITechnical reportThe EMCDDA i
Page 53 and 54: D1.1.D1.2.Animal dataHere, data reg
Page 55 and 56: E6. Possible appeal of the new psyc
Page 59 and 60: Annex IISemi-quantitative assessmen
Page 61 and 62: 8 subgroups. All members give numer
Page 63: Step 4Delphi approach:On the day of
Page 66 and 67: Risk assessment of new psychoactive
Page 74: Risk assessment of new psychoactive
Page 90 and 91: European Monitoring Centre for Drug
Page 92: About the EMCDDAThe European Monito
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Risk assessment of new psychoactive substances - EMCDDA - Europa

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