Proposal for a Council Decision On the information exchange, risk-assessment and the control on new narcotic drugs and new synthetic drugs
Date: 2003-10-03
Institutions: European Commission
Subjects: European Monitoring Centre for Drugs and Drug Addiction, drug addiction, exchange of information, health policy, information network, narcotic, scientific committee (EU)

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 03.10.2003
COM (2003) 560 final

2003/0215 (CNS)

Proposal for a

COUNCIL DECISION

On the information exchange, risk-assessment and the control on new narcotic drugs
and new synthetic drugs

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. Introduction

This Council Decision aims at updating, re-enforcing and extending the Joint Action on New
Synthetic Drugs of June 16th 1997 concerning the information exchange, risk assessment and
the control of new synthetic drugs. 1

Since 1997 five synthetic drugs2 have been examined using the provisions of the Joint Action
on  New  Synthetic  Drugs.  Two  of  them  (4-MTA  and  PMMA)  have  been  made  subject  to
control  measures  in  the  European  Union.  Council  conclusions  in  relation  to  GHB  and
ketamine were also adopted, recommending that the European Police Office (Europol) and the
European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) closely monitor the
misuse of both substances over a period of one year.

The European Union Action Plan on Drugs 2000-2004 asks the Commission to: organise an
assessment of the Joint Action on New Synthetic Drugs of June 1997 taking into account the
evaluation  by  the  EMCDDA  of  the  early  warning  system.3  In  order  to  execute  this  task  an
external evaluator was selected to carry out the evaluation. Based upon a series of interviews
with  stakeholders,  the  replies  to  an  extensive  questionnaire  sent  to  the  parties  involved
(Member  States,  Europol,  the  European  Commission,  the  European  Agency  for  the
Evaluation of  Medicinal  Products  (EMEA),  and  the  EMCDDA)  and  desk  research,  a  report
has been produced, which was made available in November 2002.4

2. Outcome of the evaluation

The  assessment  of  the  external  evaluator  indicated  that  the  Joint  Action  on  New  Synthetic
Drugs  plays  a  significant  role  in  the  combat  against  drugs.  Nevertheless,  the  evaluation
concluded that the Joint Action on  New  Synthetic  Drugs  is  in  need  of  a  re-orientation  with
respect to its objective and scope. Furthermore, the evaluation made clear that clarification of
the applicable procedures and enhancement of the transparency of its operation in practise is
necessary.

By  means  of  this  Council  Decision  the  mechanism  as  created  by  the  Joint  Action  on  New
Synthetic  Drugs  is  being  adapted  significantly,  but  incrementally,  as  its  established  basic
structure  remains  unaffected.  This  Council  Decision  consists  of  the  three  consecutive  but
independent phases created by the Joint Action on New Synthetic Drugs:

(cid:1)  an  early  warning  system  (EWS)  to  exchange  rapidly  all  information  available  on

substances notified to Europol and the EMCDDA;

(cid:1)  a risk-assessment by a scientific committee in order to assess the social, health and other

risks associated with a notified substance;

(cid:1)  an  EU-level  procedure  for  bringing  notified  substances  under  control  in  the  Member

States.

1

2

3

4

OJ L 167, 25.06.1997, p.1-3.
MBDB, 4-MTA, GHB, Ketamine and PMMA.
COM (1999) 239 final; Action Point 2.2.5.
“Assessment  of  the  Joint  Action  on  New  Synthetic  Drugs  16th  June  1997”  by  The  Evaluation
Partnership Limited, 26th October 2002.

2

                                                
3. Changes to the Joint Action

The changes to the Joint Action are directly related to the outcome of the external evaluation.
Besides the redrafting of those definitions and procedures that have proven to be unclear, the
most  important  innovation  is  that  this  Council  Decision  includes  under  its  scope  all  new
synthetic drugs and all new narcotic drugs alike, including those drugs that could be defined
as medicinal products.

This extended scope, which will permit the notification of  a  wider range of  substances than
under the former Joint Action on New Synthetic Drugs, will not lead to an enhanced use of
the risk-assessment and the control-measures (the second and third phase). The phases of risk-
assessment and control are restricted to a small number of the substances that come within the
scope  of  the  Council  Decision.  Most  notably,  medicinal  products  and  substances  already
under  assessment  by  the  United  Nations  are  excluded  from  these  phases.  Thus,  a  sharper
separation  between  the  early  warning  system  and  the  procedures  of  risk-assessment  and
control will be created. With these proposals the relevance of the instrument for the Member
States will be enhanced, taking into account its use in practice.

Other  changes  are  the  result  of  a  more  fundamental  re-orientation  of  the  established  Joint
Action’s  mode  of  operation.  Originally,  the  Joint  Action  had  been  designed  to  operate  as  a
quick  response  mechanism  aimed  at  achieving  a  rapid  exchange  of  information  on  a  new
synthetic substance and the quick synchronisation of its legal status in the Member States, in
case  of  a  sudden  surge  in  the  presence  of  this  substance  within  the  European  Union.  In
practise,  another  important  task  has  been  added  over  time.  Nowadays,  the  long  term
monitoring  of  a  synthetic  substance  by  a  continuous  exchange  of  information  between
Member  States  and  Europol/  EMCDDA,  possibly  followed  by  a  procedure  aimed  at
controlling the substance, could be considered as prominent a function as its quick response-
task. However, the fusion of both objectives in one instrument is not self-evident and might
lead  to  confusion  and  to  questions  of  legitimisation  and  legitimacy  in  case  information
collected for one goal would be used to support another. Therefore, in this Council Decision a
choice between both uses had to be made. This Council Decision has been drafted from the
perspective of a quick response mechanism, which indicates a return to the original intentions
of  the Joint Action  as  set  out in its  preamble. Even so a continuous  flow  of  information  on
new drugs amongst the Member States is valuable and must not be hampered by unnecessary
formalities.  In  order  to  reconcile  both  practises  the  Council  Decision  makes  a  distinction
between  notified  substances  that  demand  prompt  measures  at  European  Union  level,  and
substances that do not demand prompt measures. This distinction has been made operational
by the inclusion of two specific provisions:

– 

– 

the inclusion of a deadline by which the Joint Report by Europol and the EMCDDA
must be submitted to the Member States, the EMEA and the Commission. In case no
Joint Report by Europol/EMCDDA has been submitted by this deadline the phases of
risk-assessment and control remain closed.

the  provision  of  some  discretion  to  Europol  and  the  EMCDDA  whether  or  not  to
draw up a Joint Report. Though in principle a notification of a new narcotic drug or a
new  synthetic  drug  under  this  Council  Decision  should  be  followed  up  by  a  Joint
Report, it can be assumed that not all notifications would merit such a follow-up. As
not  all  cases  in  which  a  deviation  from  the  principle  that  a  notification  should  be
followed  by  a  Joint  report  can  be  foreseen  in  advance,  a  certain  flexibility  is
necessary. Therefore no explicit criteria have been included in this Council Decision.
First and foremost, a prudent judgement is required to be exercised by both bodies,

3

but Europol and the EMCDDA are also invited to develop  policy  guidelines which
could be used to select those notifications that would demand a risk-assessment. The
choices made by  Europol and the EMCDDA  in this respect should be  explained in
the  annual  report  on  the  operation  of  the  Council  Decision.  This  report  is  to  be
prepared  annually  by  Europol  and  the  EMCDDA  in  order  to  provide  adequate
feedback to those Member States that have notified substances to the early warning
system, and insight into the working of the instrument in general.

The early warning system may therefore be used for the exchange of information on, and thus
the  monitoring  of,  new  narcotic  drugs  and  new  synthetic  drugs  alike,  including  medicinal
products. However, under this Council Decision a risk-assessment will only be allowed when
specific conditions are fulfilled.

Another  fundamental  change  will  be  the  re-emphasis  on  the  principle  of  subsidiarity  with
respect  to  the  use  of  control  measures.  The  Council  Decision  should  address  these  issues,
which  cannot  be  effectively  dealt  with  by  Member  States  individually.  In  this  Council
Decision the necessary presence of such an overall interest is expressed by the introduction of
a  majority  threshold  with  respect  to  the  start  of  a  risk-assessment  on  a  notified  substance.
Only where more than half of the Member States of the European Union have indicated to be
in favour of a risk-assessment on a notified new narcotic or new synthetic substance the risk-
assessment will be carried out.

A final change concerns  the EMCDDA-Scientific  Committee,  which,  extended with  experts
from the Member States and representatives of the Commission, the EMEA and Europol, is
responsible for the carrying out of the risk-assessment. At present, all Member States may, in
addition  to  their  representative  on  the  EMCDDA-Scientific  Committee,  nominate  an  expert
for the implementation of the risk-assessment. The Council Decision proposed here deviates
from this policy line. After the completion of the enlargement process of the European Union
the  extended  Scientific  Committee  might  be  of  a  size  which  would  make  it  unmanageable.
Instead, as a consequence of this Council Decision, the extended Scientific Committee will be
composed  of  the  members  of  the  EMCDDA  Scientific  Committee  and  representatives  from
the  Commission,  the  EMEA,  and  Europol.  To  this  body  will  be  added  at  most  five  experts
from  scientific  fields  not  (sufficiently)  represented  in  the  Scientific  Committee,  but  whose
contribution  is  necessary  for  the  balanced  and  adequate  assessment  of  the  risks  associated
with the assessed substance, including health and social risks. The reference to experts from
scientific  fields  not  currently  represented,  or  currently  not  sufficiently  represented,  on  the
Scientific Committee relates to the circumstance that a balanced risk-assessment, which takes
into account different types of risks, demands the presence of experts in all relevant fields.

4. The choice of the legal instrument

Since the entering into force of the Amsterdam Treaty and the subsequent amendment of the
Treaty on European Union the Joint Action is no longer available as a legal instrument, which
made it necessary  to choose  a new legal instrument. The adaptation  of the Joint  Action  has
not  lead  to  a  significantly  different  approach  than  taken  before  as  this  Council  Decision
continues  to  ask  from  Member  States  to  put  control-measures  on  specific  substances  which
have  passed  through  the  stages  of  notification  and  risk-assessment.  These  control-measures
were  not  defined  in  detail  in  the  1997  Joint  Action  on  New  Synthetic  Drugs,  nor  are  they
defined in detail  in this  Council  Decision. As these are  left  to  the  discretion  of  the  national
legislator, the Member States are not asked to adapt their legislation, but to make effective use
of the existing provisions in their legislation. These circumstances make a Council Decision
the most appropriate legal instrument available to succeed the Joint Action.

4

5. Analysis per Article

This  Council  Decision  consists  of  13  Articles.  Some  of  the  Articles  describe  the  procedure
from notification to control-measures, while others are related to the scope of this instrument
or contain definitions.

Article  1  describes  the  purpose  of  the  Council  Decision.  It  emphasises  that  the  Council
Decision does not envisage a duplication of the pharmacovigilance system as established by
Directive 2001/83/EC of the European Parliament and of the Council, which has been created
to report suspected adverse reactions to a medicinal product. As it might not be clear from the
outset whether or not an incident involving a new narcotic drug or a new synthetic drug would
fulfil  the  reporting  criteria  under  the  pharmacovigilance  system,  Article  11  of  this  Council
Decision asks Member States to maintain a close link between the mechanism created by this
Council Decision and the pharmacovigilance system.

Article 2 is concerned with the scope of the Council Decision. The Article defines under the
scope of this legal instrument all substances, which have not been listed under either the 1961
United Nations Single Convention on Narcotic Drugs or the 1971 United Nations Convention
on Psychotropic Substances.

Therefore  substances  listed  under  either  the  1961  United  Nations  Single  Convention  on
Narcotic  Drugs  or  the  1971  United  Nations  Convention  on  Psychotropic  Substances  do  not
come within the scope of this Council Decision.

Article 3 contains the definitions used throughout the Council Decision.

Article  4  describes  the  notification  procedure  a  Member  State  should  follow  after  the
discovery of a new narcotic drug or a new synthetic drug on its territory. Article 4 also sets
out  the  work  to  be  undertaken  jointly  by  the  EMCDDA  and  Europol  as  a  follow-up  to  a
notification  by  a  Member  State:  the  EMCDDA  and  Europol  are  asked  to  collect  the
information available on the notified substance. The Article contains a list of issues on which
information  should  be  collected.  However,  at  the  same  time,  Article  4  attributes  a  certain
discretion to Europol and the EMCDDA to judge whether or not prompt measures, and thus
the collection of information, would be desirable.

By means of Article 5 the EMCDDA and Europol are asked to collate a Joint Report from the
information gathered under the provisions of Article 4.

Article 6 describes the procedure relevant to the assessment of risks associated with a notified
substance. In order to fulfil the criterion of subsidiarity, more than half of the Member States
of  the  European  Union  should  agree  on  the  risk-assessment  by  the  extended  EMCDDA
Scientific Committee. During the period of thirty working days which is given to the Member
States  in order  to come  to a decision,  they will  have  sufficient  time  to  consult  their  experts
and  to  assess  their  national  situation  with  respect  to  the  notified  substance.  Also,  Article  6
contains a list of issues, which should be included in the risk-assessment report.

Article  7  lists  the  circumstances,  which  would  disqualify  a  notified  substance  from  being
assessed  on  its  risks  as  indicated  in  Article  6.  Most  importantly,  Article  7  states  that
substances that would qualify as medicinal products as categorised under this Article, will not
be assessed on their risks under this Council Decision. Measures to be taken to diminish the
abuse  of  these  medicinal  products  could  be  considered  by  the  EMEA  and  the  Council.  The
EMEA  could,  based  upon  a  scientific  assessment  of  the  risks  associated  with  a  medicinal

5

product,  submit  advice  on  the  classification  of  the  medicinal  product  involved,  while  the
Public  Health  Group  of  the  Council  could  decide  on  proper  public  health  related  measures
with respect to the substance.

Article 8 describes the procedure for applying control-measures to a  new narcotic drug or  a
new synthetic drug.

Article 9 describes the responsibility of the Member States with respect to the substances that
are placed under control as described in Article 8.

Article 10 demands that the EMCDDA and Europol prepare a report on the operation of the
Council Decision. The main aim is to increase the transparency of the instrument.

Article 11 relates to the pharmacovigilance system, which has been established EU-wide as a
post-marketing surveillance system for authorised medicinal products. Member States, health
care  practitioners  and  the  pharmaceutical  industry  are  permanently  assessing  the  safety  of
marketed  medicinal  products  by  reporting  the  suspected  adverse  reaction  to  medicinal
products  they  have  encountered,  or  that  were  reported  to  them,  to  the  pharmacovigilance
system. The major public health interests concerned here are such that there should be no loss
of time caused by an accidental reporting of information relevant for the pharmacovigilance
system to the Early Warning System only. Therefore Member States and the EMEA are asked
to link the Early Warning System closely with the pharmacovigilance system.

Article 12 deals with the repeal of the predecessor of this Council Decision, the Joint Action
on New Synthetic Drugs of June 16th 1997.

Article 13 contains the provisions on publication and entry into force of the Council Decision.

6. Financial consequences

This Council Decision does not have financial implications.

6

2003/0215 (CNS)

Proposal for a

COUNCIL DECISION

On the information exchange, risk-assessment and control on new narcotic drugs and
new synthetic drugs

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Articles 29 and 34 (2) (c)
thereof,

Having regard to the proposal from the Commission5,

Having regard to the opinion of the European Parliament6,

Whereas:

(1) 

The  particular  dangers  inherent  in  the  development  of  synthetic  drugs  and  narcotic
drugs require rapid action by the Member States.

(2)  When new narcotic drugs and new synthetic drugs are not brought within the scope of
criminal law in all Member States, problems may arise in the co-operation between the
judicial authorities and law enforcement agencies of the Member States owing to the
fact that the offence or offences in question are not punishable under the laws of either
the requesting or the requested State.

(3) 

The  European  Union  Action  Plan  on  Drugs  2000-2004  asks  the  Commission  to
organise  an  appropriate  assessment  of  the  Joint  Action  on  New  Synthetic  Drugs  of
June  19977  taking  into  account  the  external  evaluation  commissioned  by  the
EMCDDA  of  the  early  warning  system.  The  assessment  has  shown  that  the  Joint
Action  on  New  Synthetic  Drugs  has  fulfilled  its  expectations.  Nevertheless,  the
outcome of the assessment made clear that the Joint Action is in need of reinforcement
and  re-orientation.  In  particular,  its  main  objective,  the  clarity  of  its  procedures  and
definitions, the transparency of its operation, and the relevance of its scope should be
redefined. The Communication from the Commission to the Council and the European
Parliament on the mid-term evaluation of the EU Action Plan on Drugs (2000-2004) 8
has  indicated  that  changes  to  the  legislation  will  be  introduced  in  order  to  enhance
action  against synthetic drugs. The mechanism as established  by the  Joint  Action on
New Synthetic Drugs of June 16th 1997 should therefore be adapted.

(4) 

New narcotic drugs can be as harmful to health as new synthetic drugs.

5

6

7

8

OJ C […], […], p. […].
OJ C […], […], p. […].
OJ L 167, 25.06.1997, p.1-3
COM/2002/0599 final, page 18.

7

                                                
(5) 

(6) 

(7) 

(8) 

(9) 

The information exchange under the early warning system, established under the Joint
Action on New Synthetic Drugs having proved to be a valuable asset to the Member
States, this system may also be used to disseminate information on the occurrence of
unanticipated public health threats associated with the use of illicit drugs.

No infringement on the quality of either human or veterinary health care by means of
this  Decision  could  be  allowed.  Substances  with  an  established  and  acknowledged
medical  value  are  therefore  excluded  from  control-measures  based  on  this  Decision.
For  substances  with  an  established  and  acknowledged  medical  value  that  are  being
misused suitable regulatory and public health related measures should be taken.

The  introduction  of  deadlines  in  every  phase  of  the  procedure  established  by  this
Decision  should  guarantee  the  speediness  of  the  instrument  and  emphasises  its
character as a quick response mechanism.

The  Scientific  Committee  of  the  European  Monitoring  Centre  on  Drugs  and  Drug
Addiction having  a  central  role  in  the  assessment  of  the  risks  associated  with  a  new
narcotic substance or a new synthetic substance, it will for the purpose of this Decision
be extended to experts from the Commission,  Europol and the  European  Agency  for
the  Evaluation  of  Medicinal  Product,  and  to  experts  from  scientific  fields  not
represented,  or  not  sufficiently  represented,  in  the  Scientific  Committee  of  the
European Monitoring Centre on Drugs and Drug Addiction.

The  extended  Scientific  Committee  that  assesses  the  risks  associated  with  new
narcotic  drugs  or  new  synthetic  drugs  should  remain  a  concise  technical  body  of
experts,  capable  of  assessing  effectively  all  risks  associated  with  a  new  narcotic
substance or a new synthetic substance. Therefore the size of the extended Scientific
Committee should remain manageable.

(10)  Since  the  objectives  of  the  proposed  action,  namely  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  Community  level,  the  Community  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, the Decision does not go
beyond what is necessary to achieve those objectives.

(11) 

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

(12)  This Decision respects the fundamental rights and observes the principles recognised

in particular by the Charter of Fundamental Rights of the Union.

HAS ADOPTED THIS DECISION:

8

Article 1

Subject matter

This Decision establishes a mechanism for a rapid exchange of information on new narcotic
drugs  and  new  synthetic  drugs  that  are  being  used  illicitly  or  misused.  It  does  not  cover
information  on  suspected  adverse  reactions  to  be  reported  under  the  pharmacovigilance
system as established by Title IX of Directive 2001/83/EC of the European Parliament and of
the Council.9

This Decision also provides for an assessment of the risks associated with these new narcotic
drugs and new synthetic drugs in order to permit the application of the measures of control on
narcotic  and  psychotropic  substances,  applicable  in  the  Member  States  equally  to  new
narcotic drugs or to new synthetic drugs.

Article 2

Scope

This decision applies to substances not currently listed in any of the schedules to:

a) the 1961 United Nations Single Convention on Narcotic Drugs,

that pose a comparable threat to public health as the substances listed in Schedule I
or II or IV; and

b) the 1971 United Nations Convention on Psychotropic Substances,

that pose a comparable threat to public health as the substances listed in Schedule I
or II or III or IV;

This Decision relates to end-products, as distinct from precursors in respect of which Council
Regulation  (EEC)  No  3677/9010,  and  Council  Directive  92/109/EEC11  provide  for  a
Community regime.

Article 3

Definitions

For the purpose of this decision the following definitions shall apply:

a)

9

10

11

‘new narcotic drug’: a substance, that has not been scheduled under the 1961 United
Nations  Single  Convention  on  Narcotic  Drugs,  and  that  poses  a  threat  to  public
health comparable to the substances listed in Schedule I, II or IV.

OJ L 311 of 28.11.2001, p. 67, as last amended by Directive 2002/98/EC (OJ L 33, 8.2.2003, p.30-40
OJ L 357, 20.12.1990, p.1, as last amended by Regulation (EC) No 1116/2001(OJ L 153, 8.6.2001, p.4)
and Commission Regulation (EC) No 1232/2002 (OJ L 180, 10.7.2002, p.5).
OJ L 370, 19.12.1992, p.76.

9

                                                
b)

c)

d)

e)

1.

2.

‘new synthetic drug': a substance that has not been scheduled under the 1971 United
Nations  Convention  on  Psychotropic  Substances,  and  that  poses  a  threat  to  public
health comparable to the substances listed in Schedule I, II, III or IV;

‘marketing authorisation’: the permission to place on the market of a Member State
either  a  medicinal  product  for  human  use  as  indicated  in  Title  III  of  Directive
2001/83/EC of the European Parliament and of the Council, or a veterinary medicinal
product as indicated in Title III of Directive 2001/82/EC of the European Parliament
and of the Council.

‘United  Nations-system’:  the  World  Health  Organisation  (WHO),  the  Commission
on  Narcotic  Drugs  (CND)  and/or  the  Economic  and  Social  Committee  (Ecosoc)
acting in accordance within 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.

‘preparation’:  a  mixture  containing  either  a  new  narcotic  drug  or  a  new  synthetic
drug.

Article 4

Exchange of information

Each  Member  State  shall  ensure  that  its  Europol  National  Unit  of  the  European
Police  Office  ("Europol")  and  its  representative  in  the  Reitox  network  provide
information on the production, traffic and use, including medical use, of new narcotic
drugs and of new synthetic drugs and of preparations containing new narcotic drugs
or  new  synthetic  drugs,  to  Europol  and  the  European  Monitoring  Centre  on  Drugs
and  Drug  Addiction  ("EMCDDA"),  taking  into  account  the  respective  mandates  of
these two bodies. Europol and the EMCDDA shall collect the information received
and  communicate  this  information  immediately  to  each  other  and  to  the  Europol
National Units and the representatives of the Reitox-network of the Member States,
the  Commission,  and  to  the  European  Agency  for  the  Evaluation  of  Medicinal
Products ("EMEA").

Europol and the EMCDDA shall supplement the information on a new narcotic drug
or a new synthetic drug or on a preparation containing a new narcotic drug or a new
synthetic  drug  obtained  from  a  Member  State  to  the  extend  that  the  information
available shall entail:

(a)

(b)

a chemical and physical description, including the name under which the new
narcotic drug or the new synthetic drug is known,

information on the frequency, circumstances and/or quantities in which a new
narcotic  drug  or  new  synthetic  drug  is  encountered,  and  information  on  the
means  and  methods  of  production  of  the  new  narcotic  drug  or  the  new
synthetic drug,

(c)

information  on  the  involvement  of  organised  crime  in  the  production  or
trafficking of the new narcotic drug or the new synthetic drug,

10

(d)

(e)

(f)

(g)

a  first  indication  of  the  risks  associated  with  the  new  narcotic  drug  or  new
synthetic drug, including health and the social risks,

information on whether or not the new narcotic drug or the new synthetic drug
is currently under assessment, or has been under assessment by the UN-system,

the moment of notification of the new narcotic drug or the new synthetic drug
to the EMCDDA or to Europol,

information on whether or not the new narcotic drug or the new synthetic drug
is already subject to control measures at national level in a Member State.

(h) As far as possible, information will be made available on:

(i)

the chemical precursors,

(ii)

the  mode  and  scope  of  the  established  or  expected  use  of  the  new
synthetic drug or the new narcotic drug,

(iii) other use of the new narcotic drug or new synthetic drug and the  extent
of such use, the risks associated with this use of the new narcotic drug or
new synthetic drug, including the health and the social risks;

3.

The  EMEA  shall  submit  to  Europol  and  the  EMCDDA  supplementary  information
on whether in the European Union or in any Member State:

(a)

(b)

the  new  narcotic  drug  or  new  synthetic  drug  has  obtained  a  marketing
authorisation;

the  new  narcotic  drug  or  new  synthetic  drug  is  in  the  process  of  obtaining  a
marketing authorisation;

(c)

a provided marketing authorisation has been suspended.

Where this supplementary information relates to marketing authorisations granted by
Member States, these Member States shall provide this information to the EMEA on
request from the EMEA.

4.

5.

Member States are requested to deliver the information referred to under paragraphs
(2) and (3) without unnecessary delay.

In  case  Europol  and  the  EMCDDA  consider  that  the  information  provided  by  a
Member State on a new  narcotic  drug  or  a new synthetic drug  would not  merit the
further collection of information as described in paragraph (1), they will inform the
notifying Member State instantly hereof, and the risk assessment procedure referred
to in Article 6 will not apply. Europol and the EMCDDA  will explain the decision
taken in the annual report as referred to in Article 10.

11

1.

2.

1.

2.

3.

4.

5.

Article 5

Joint Report

The  information  collected  shall  be  collated  and  presented  by  Europol  and  the
EMCDDA in the form of a Joint Report (hereinafter the "Joint Report"), which shall
be submitted directly to the Member States, the EMEA and the Commission

The Joint Report shall be submitted no more than thirty working days after the date
of  reception  of  information  from  Member  States  by  Europol  or  the  EMCDDA  in
accordance with paragraph (1) of Article 4.

Article 6

Risk assessment

The risks, including the health and social risks, caused by the use of, the production
of,  and  traffic  in,  a  new  narcotic  drug  or  a  new  synthetic  drug,  the  involvement  of
organised  crime  and  possible  consequences  of  prohibition  shall  be  assessed  in
accordance with the procedure set out in paragraphs 2 to 5, provided that more than
half of the  Member  States  have informed the Council  in  writing  to  be  in  favour  of
such an assessment. The Member States shall inform the Council as soon as possible,
but  in  any  case  within  thirty  working  days  after  the  date  of  reception  of  the  Joint
Report.

As  soon  as  more  than  half  of  the  Member  States  have  informed  the  Council  in
writing  to  be  in  favour  of  a  risk-assessment  on  a  new  narcotic  drug  or  a  new
synthetic  drug  as  indicated  in  paragraph  (1),  the  Council  shall  alert  the  EMCDDA
and Europol.

In order to carry out the assessment, the EMCDDA shall convene a special meeting
under  the  auspices  of  its  Scientific  Committee.  In  addition,  for  the  purpose  of  this
meeting the Scientific  Committee  shall be  extended with at  most five  experts,  who
are specialists in scientific fields not represented, or not sufficiently represented, in
the Scientific Committee,  but whose contribution  is necessary  for the balanced  and
adequate  assessment  of  the  possible  risks,  including  health  and  social  risks.
Furthermore,  the  Commission,  Europol  and  the  EMEA  shall  be  invited  to  send  a
maximum of two experts each to this meeting.

The risk-assessment shall be carried out on the basis of information to be provided to
the  Committee  as  described  in  paragraph  3  (hereinafter  "the  Committee")  by  the
Member States, the EMCDDA, Europol, the EMEA, taking into account all  factors
which, according to the 1961 United Nations Single Convention on Narcotic Drugs
or the 1971 United Nations Convention on Psychotropic Substances, would warrant
the placing of a substance under international control.

On  completion  of  the  risk-assessment,  a  report  (hereinafter  the  "Risk-Assessment
Report")  will  be  drawn  up.  The  risk-assessment  shall  consist  of  an  analysis  of  the
scientific  information  available,  and  will  include  possible  dissenting  scientific
opinions held by the members of the Committee. The Risk-Assessment Report shall

12

be submitted to the Commission by the chairman of the Committee within a period
of ninety working days, as from the date of the information from the Council to the
EMCDDA and Europol referred to in paragraph (2).

The Risk-Assessment report shall include:

(a)

the  physical  and  chemical  description  of  the  new  narcotic  drug  or  the  new
synthetic drug and its working, including its medical value,

(b)

the health risk associated with the new narcotic drug or the new synthetic drug,

(c)

(d)

(e)

(f)

the  social  risks  associated  with  the  new  narcotic  drug  or  the  new  synthetic
drug,

information on the level of involvement of organised crime and information on
seizures, and production of the new narcotic drug or the new synthetic drug,

information  on  the  assessment  of  the  new  narcotic  drug  or  the  new  synthetic
drug in the United Nations-system,

a  description  of  the  control-measures  to  which  the  new  narcotic  drug  or  the
new synthetic drug is submitted in the Member States, when applicable,

(g)

options for control and the possible consequences of prohibition.

Article 7

Circumstances where no risk assessment shall be carried out

1.

2.

3.

No  risk-assessment  shall  be  carried  out  in  case  the  new  narcotic  drug  or  the  new
synthetic  drug  concerned  is  currently  under  assessment  within  the  United  Nations-
system.

In case the new narcotic drug or the new synthetic drug has been under assessment
within the United Nations system without the decision having been taken to schedule
the new narcotic drug or the new synthetic drug under the 1961 Single Convention
on  Narcotic  Drugs  or  the  1971  Convention  on  Psychotropic  Substances  a  risk-
assessment  shall  only  be  carried  out  when  there  is  significant  new  information
relevant in the framework of this Decision.

No  risk-assessment  shall  be  carried  out  on  a  new  narcotic  drug  or  a  new  synthetic
drug in case it falls within one of the following categories:

(a)

The  new  narcotic  drug  or  the  new  synthetic  drug  is  an  ‘authorised  medicinal
product’ which is either a medicinal product intended for human use, that has
been granted a marketing authorisation in one or more Member States or in the
European  Union  in  accordance  with  the  provisions  of  Title  III  of  Directive
2001/83/EC12,  or  a  veterinary  medicinal  product  that  has  been  granted  a
marketing  authorisation  in  one  or  more  Member  States  or  in  the  European

12

OJ L 311, 28.11.2001, p. 67

13

                                                
Union in accordance with the provisions of Title III of Directive 2001/82/EC13;
or,

(b) The new narcotic drug or the new synthetic drug is a ‘medicinal product under
review’,  which  is  either  a  medicinal  product  intended  for  human  use  that  is
under examination in order  to  be  granted  a  marketing  authorisation  in  one  or
more  Member  States  or  in  the  European  Union  in  accordance  with  the
provisions  of  Title  III  of  Directive  2001/83/EC,  or  a  veterinary  medicinal
product  that  is  under  examination  in  order  to  be  granted  a  marketing
authorisation  in  one  or  more  Member  States  or  in  the  European  Union  in
accordance with the provisions of Title III of Directive 2001/82/EC; or,

(c)

The  new  narcotic  drug  or  the  new  synthetic  drug  is  a  ‘suspended  medicinal
product’, which is either a medicinal product intended for human use for which
the marketing authorisation is suspended in one or more Member States or in
the European Union, or a veterinary medicinal product for which the marketing
authorisation  is suspended in one  or  more  Member  States  or  in  the  European
Union; or,

(d) The  new  narcotic  drug  or  the  new  synthetic  drug  is  an  ‘exempted  medicinal
product’,  which  is  either  a  medicinal  product  for  human  use,  which  is
exempted from having a marketing authorisation as specified under Article 7 of
Directive  2001/83/EC,  or  a  veterinary  medicinal  product;  which  is  exempted
from  having  a  marketing  authorisation  as  specified  in  Article  8  of  Directive
2001/82/EC.

In the  case the  new  narcotic  drug  or  the  new  synthetic  drug  falls  into  one  of  the  categories
listed under this paragraph, it will be referred to the EMEA for a scientific evaluation of the
risks associated with the new narcotic drug or the new synthetic drug  and to the Council in
order to discuss public health related measures.

Article 8

Procedure for bringing specific new narcotic and new synthetic drugs under control

1.

2.

Within thirty working days from the date on which the Risk-Assessment Report has
been received, the Commission shall present to the Council an initiative to have the
new narcotic drug or new synthetic drug subjected to control measures.

If  the  Commission  deems  it  not  necessary  to  present  an  initiative  to  have  the  new
narcotic drug or the new synthetic drug submitted to control measures, it shall within
thirty  working  days  from  the  date  on  which  the  Risk-Assessment  Report  has  been
received present a report to the Council explaining its views.

When  the  Commission  presents  the  Council  with  an  initiative,  the  Council  shall
decide  by  qualified  majority,  on  the  basis  of  the  said  initiative  and  acting  in
accordance with Article 34 (2) (c) of the Treaty, whether to submit the new narcotic
drug or the new synthetic drug to measures of control.

13

OJ L 311, 28.11.2001, p. 1

14

                                                
3.

1.

2.

3.

The procedure provided for by this Article shall take no longer than ninety working
days from the date of reception by the Council of the initiative by the Commission to
the date of adoption by the Council of the initiative by the Commission as referred to
in paragraph (2).

Article 9

Control measures taken by Member States

If  the  Council  decides  to  submit  a  new  narcotic  drug  or  a  new  synthetic  drug  to
measures  of  control,  Member  States  shall  take  within  one  year  the  necessary
measures in accordance with their national law to submit:

(a)

(b)

the new synthetic drug to control measures and criminal penalties as provided
under their legislation complying with their obligations under the 1971 United
Nations Convention on Psychotropic Substances.

the new  narcotic drug  to  control  measures  and  criminal  penalties  as  provided
under their legislation complying with their obligations under the 1961 United
Nations Single Convention on Narcotic Drugs.

Member  States  shall  report  the  measures  taken  to  both  the  Council  and  the
Commission.

Nothing  in  this  Decision  shall  prevent  a  Member  State  from  maintaining  or
introducing  on  its  territory  any  national  control  measure  it  deems  appropriate  once
this Member State has identified a new narcotic drug or a new synthetic drug.

Article 10

Annual report

The  EMCDDA  and  Europol  shall  report  annually  to  the  Council  on  the  operation  of  this
Decision.  The  report  will  take  into  account  all  aspects  relevant  to  judge  the  efficacy  and
achievements of the system created by this Decision.

Article 11

Pharmacovigilance-system

Member States and the EMEA shall secure 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/EC14 and Title IX of Directive
2001/83/EC15.

14

15

OJ  L  311  of  28.11.2001,  p.  0001–0066,  Directive  2001/82/EC  of  the  European  Parliament  and  the
Council of 6 November 2001 on the Community code relating to veterinary medicinal products.
OJ  L  311  of  28.11.2001,  p.  0067–0128,  Directive  2001/83/EC  of  the  European  Parliament  and  the
Council of 6 November 2001 on the Community code relating to medicinal products for human use

15

                                                
Article 12

Repeal

The Joint Action on New Synthetic Drugs of June 16th 1997 is hereby repealed.

Article 13

Publication and entry into force

This Decision shall be published in the Official Journal of the European Union. It shall take
effect the day following that of its publication.

This Decision is addressed to the Member States.

Done at Brussels, […]

For the Council
The President
[…]

16