Transcript Narcotic issues - u

„Controlled substances”
• Narcotics (substances and
preparations)
• Psychotropic substances
• Precursor substances
Narcotic issues
UN Single convention on
narcotic drugs 1961
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UN Single convention
• Issued in 1961 in New York and as
amended
• Signatories (“Parties”) >100
countries
• only the medicinal affairs are
outlined here
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Preamble
• medical use of narcotics
indispensable
• narcotic drugs can be serious evil
• effective measures against their
abuse = international co-operation
needed under the aegis of United
Nations
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Definitions
• [narcotic] drug = substance in the
Schedules of the Convention (legal
definition!), organic or synthetic
• licit traffic = for medicinal/scientific
purposes
• illicit traffic: for any other purposes
• UN Economical and Social Council
(ECOSOC) for general supervision
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Schedules (lists)
• Schedule I substances = full control (as
specified in the text)
• Schedule II substances = some
exemptions
• Schedule III preparations = the same plus
more exemptions
• not Schedule III preparations = other
exemptions
• Schedule IV substances = as Schedule I
plus special measures and complete
prohibition
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Other substances
• If not scheduled but may be illicit
use: the same measures apply
• But not applicable for industrials
which can not be used as narcotics
or denatured
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As we have seen:
• the “narcotic drugs” are not defined
by their biological action. Narcotic is
what is scheduled!
• Why? There is no strict borderline,
sometimes it is difficult to decide!
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The WHO is...
• ...to advise whether a new substance
is liable to abuse  UN Commission
on Narcotic Drugs  scheduling
• UN Economic and Social Council Commission (amending the
Schedules) - International Narcotic
Control Board (INCB)
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INCB, 1
• Executive Body
• setting limits for Parties (signatoree
states: export/import, production,
etc. of narcotic drugs)
• collecting and evaluating country
estimates and statistics, etc.
• May alter the Governments’
estimates
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INCB, 2
• It may require Governments to
explain if the Convention is violated.
Calls to adopt measures.
• If problem, refers it to the ECOSOC,
recommend other Parties to stop
export/import from this country,
publish its report openly
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Political will
• The Parties implement and enforce
the measures in their legislation, cooperate with each other
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Parties
inform UN Secretary-General on
• their annual reports
• texts of laws concerning narcotic
drugs
• any other requested issues (illicit
traffic, etc.)
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The parties send annually
to the INCB
• statistics of the preceding year
• estimates for the next year
on their factual/expected narcotic
consumptions, stocks, imports,
exports, etc.
Estimates
Sent by the Parties to INCB annually.
(Not needed for Schedule III and notIII preparations!) Estimations for the
next year on
• quantities needed for medicinal
purposes
• the same for manufacture of other
drugs
• stocks expected to remain on 31
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December
Estimates (continued)
• specific stocks (catastrophe, etc.)
• the area (hectares, acres, km2) and
location for cultivation of opium poppy
• expected quantities of opium to be
produced
• number of factories manufacturing
synthetic narcotics, quantities by each
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Estimates (continued)
• Estimates can be modified during the
year explaining the reason (e.g.
seizing narcotic drugs and directing
it to licit use)
• Estimates published by INCB
annually
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Statistics
from the Parties to INCB. )Not needed
for Schedule III and not-III
preparations, only for their
substances!) Statistics of the
preceding year on
• quantities manufactured
• the same for manufacture of other
drugs
• Consumption
(continued)
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Statistics (continued)
• stock on 31 December
• import and export quantities (also for
poppy straw)
• the area (hectares and location) of
cultivation of opium poppy
• seizures and disposal
Annually (except import/export:
quarterly)
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Limitation of manufacture
and import, 1
• Quantities of manufacture + import
not more than
• consumed + used for manufacture of
other drugs + export + added to
special stocks + estimated + seized
and directed to licit use
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Limitation of manufacture
and import, 2
If INCB finds it exceeds the limitation
set by INCB:
• notifies the Party
• it shall be deducted next year
• notifies other concerned Parties (be
careful when import or do not
import…)
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Limitation of production of
opium
National Opium Agency
• (not detailed, no significance from
medicinal point of view)
• only see the next 2 slides
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Special provision to cultivation
• Opium poppy (Papaver somniferum L.
with high alkaloid content), Coca bush,
Cannabis plant
• Should be kept under control. If danger of
illicit use, complete prohibition!
• Increasing opium production: only when
reasoned and accepted by INCB (no
overproduction!)
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In Hungary, e.g.
• cultivation of high alkaloid poppy
(varietas listed in a Decree) and
cannabis with >0.3% THC: only with
licence
• Concession holders and its
contractors only
• seeds from certified sources,
unused/not contracted poppy straw
wasted, etc.
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Manufacture
• In possession of special licence or
by State enterprise
• Persons and enterprises under
control
• Periodical permits (kind and amount)
- not applicable for Not-Schedule III
preparations
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Trade and distribution, 1
• In possession of special licence
• Persons and enterprises under
control
• Premises also licensed (not for
preparations!)
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Trade and distribution, 2
• Should prevent accumulation at
traders and distributors
• Require medical prescription
Special prescription (Form)
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Trade and distribution, 3
• All written material (package, info):
also INN and exact quantities should
appear (not applicable to Schedule II
substances and magistral
preparations)
• Possible: double red band in the
inner package/leaflet
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International trade
Not applicable if transit by air without
landing
Export only if
• it is lawful in the importing country
• it is within the estimates (not for
Schedule III preparations)
The same for freeports, etc.
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International trade, 2
• Control export/import (unless State
enterprises), all persons, enterprises
• separate import/export authorisation
for all consignments, accompanying
the consignments, the importing
Government shall return them to the
exporting one
(not for Schedule III)
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International trade, 3
• No export to P.O.Box or bank
account
• warehouses for export certified
• even transit (passing through the
country untouched) needs
authorisation
• destination controlled and kept
(Not for Schedule III)
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International trade, 4
• no process to change the drug, no
packing alteration what is not
certified
• every user (even medical, scientific)
records of use, kept for 2 years
Not for Schedule III, only info on the
substance quantities used for
manufacture
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Specific provisions for first-aid
kits of ships/aircraft
• if limited for passenger use: not
taken as narcotic drugs
• Subject of law and permit of the
home country and inspection of the
transit countries
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Inspections
• All persons licensed or governmental
inspectors must have adequate
knowledge
• at every concerned establishments,
records on quantities kept at least for
2 years
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Action against illicit traffic,
Penal provisions, Seizure
and confiscation
• (not detailed - no pharmaceutical
significance)
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Measures against abuse of
narcotic drugs
•
•
•
•
•
early identification
treatment
education
rehabilitation
social integration...
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Closing remarks
• Stricter measures than required by
the Single Convention possible,
especially put Schedule II
substances and Schedule III
preparations under the same control
as Schedule I, if it seems necessary
for the protection of public health
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The languages
Chinese, English, French, Russian and
Spanish texts are equally authentic
(UN official languages!)
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Transitional reservations
A Party might reserve the right to permit
temporarily (detailed and with further
limitations)
• quasi-medical use of opium
• opium-smoking
• coca leaf chewing
• use of cannabis for non-medical purposes
to the extent they were traditional in the
country
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Schedules
In case of substances, their any
isomers, esters, ethers or salts
including the salts of any esters,
ethers and isomers!
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Schedule I (examples)
Controlled substances
...cannabis, coca leaf, cocaine,
ecgonine, fentanyl, heroin, morphine,
opium, pethidine, thebaine...
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Schedule II (examples)
(Less controlled substances)
...codeine, ethylmorphine,
dihydrocodeine...
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Schedule III (example)
(Preparations with a limited amount of
narcotic substance)
Preparation of codeine, ethylmorphine,
dihydrocideine containing not more
than
• 100 mg per dosage unit or
• 2.5% in undivided preparation
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Schedule III (example)
Preparation of
• cocaine, not more than 0.1% (cocaine
base)
• opium or morphine, not more than
0.2% (anhydrous morphine base) in
such a way it can not be recovered in a
yield that constitutes a risk to public
health
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Schedule III (example)
Pulvis ipecacuanhae et opii
compositus
• 10% opium powder
• 10% ipecacuanha root powder
• well mixed with other inactive
ingredient
(Why?)
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Schedule IV (example)
(Substances from Schedule I that have
no medical use)
...cannabis, heroin...
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Thus, what should be identified
in your country
• Who issues narcotic licences to
manufacture and distribution
• who can be the responsible person?
• who inspects narcotic licence holders
(MoH? Police?)
• who controls the licit traffic and transit
(Police?)
• who amends the national Schedules
(MoH?)
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Regulation of psychotropic
substances
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UN Convention on
psychotropic substances
(Vienna, 21 February 1971, as
modified)
Many similarities with the Single
Convention on narcotic drugs!
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What is similar to the Single
Convention? 1
•
•
•
•
The Preamble
The same definitions (e.g. illicit traffic)
The same UN Organs (ECOSOC, INCB)
The WHO is to recommend scheduling of
new substances
• It is not valid to personal use of
international passengers (except this
Schedule I)
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What is similar to the Single
Convention? 2
• If the substance is used for manufacture
of other substance, it must be controlled
until its characteristics changed to the
extent the new substance is not
psíchotropic or it can not be recovered
• Otherwise psychotropic substance is
permitted to use for scientific or medical
purposes exclusively
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What is similar to the Single
Convention? 3
(Except this Schedule I for, as a rule, use of
these substances are banned)
• Production, distribution: authori-sation of
persons and enterprises
• Medical prescription-only
• Annual statistics of INCB, decisions of
INCB
• Similar reservations (e.g traditional
consumption of herbs)
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Psychotropis substance
• Legal definition: scheduled in one of
Schedules I-IV of this Convention
• When is it recommended by WHO:
suitable for addiction and
causes agitation or depression of the
central nervous system, that
- gives rise to hallucination, motion or
judgement or understanding or mood
disturbances, or
- its harmful effect is similar to any of
already scheduled substances
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These Schedules
Depending on the control level of
substances:
• General limitations for all psychotropic
substances (e.g. authorisation of
activities, record keeping, medical
prescription-only, penalties)
• Special limitations for the given Schedule
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Special limitations to
Schedule I
• Only scientific (and some restricted
medical) use permitted
• Any activity only when possessing special
authorisation, under strict control, exportimport only when the competent
authorities in both countries permitted
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General limitations 1
For preparations:
• those for the psychotropic ingredient
must apply, if more the one, the strictest
limitations
• If only a very small quantity or can not be
recovered, may be exempted from the
limitations
The substances should be authorised for
certified persons, under strict control, to
catch animals (via their narcosis)
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General limitations 2
• Detailed instruction for use on the
label or package insert
Prescription only
Indication motion sickness
Maximum three times a day
It may not be used together
with the following medicinal
products:
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Records
• Schedules I–III: producer, distributor: all
manufactured or bought batches, dated,
according to required rules or Forms
• For Schedul II: the same also in hospitals
and pharmacies
• For Schedule III: these date are to be
accountable in hospitals and pharmacies
• For Schedule IV: only producers and
importers and only the quantities
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International trade
• Using the INCB Form, with special
authorisation, this accompanies the
consignment, one copy is sent back
• Schedules I-II: further limitations,
very similar to narcotics
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Statistics
• To the UN Secretary General, on national
legislation and special events
• Statistics annually:
-Schedules I-II: produced quantities, by
countries export-import quantities, stocks
-Schedules III-IV: only the total quantities of
produced and export-import
-Not for preparations!
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Schedule I (examples)
(Only for scientific purposes!)
...mescalin, psyilocibin, certain THC
isomers...
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Schedule II (examples)
(Psychotropic substances
under full control)
…amfetamin („speed”), methaqualone,
methylphenidate (Ritalin), ketamin…
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Schedule III (examples)
(Less controlled psychotropic
substances)
…amobarbital, buprenorfin,
gluthetimid…
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Schedule IV (examples)
(Psychotropic substences under the
weakest control)
…alprazolam, barbital, diazepam,
phenobarbital, mazindol, triazolam…
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What should you identify at home:
• Is your country a signatoree?
• If so, which laws implement the
Convention and regulate this field?
(E.g. MoH or Ministry of Interior
Decrees?)
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Hungarian example: the
task of MoH
• Issue/modification of the Schedules
• Regulation of the medical prescrip-tion of drugs
containing psychotropic substances
• Export/import licences
• Permission of use for scientific purposes
• Statistical data, collection and sending to INCB
• Authorisation for further manufacture and for
catching animals, etc.
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„Precursor substances”
(those that can be used in
the production of narcotic
drugs or psychotropic
substances)
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Basis:
UN Convention on
combating illicit transport of
narcotic drugs and
psychotropic substances on
20 December, 1998 in
Vienna
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This Convention
• Following the former Conventions,
assessing the situation again,
strengthening the former ones
• New measures to introduce and new
types of substances to subject to
international control
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More or less, only strengthening
the former Conventions
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Preamble
Major definitions, INCB
Illicit growing of narcotic herbs
Trade (including free ports and zones
as well as postal services)
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New/stricter measures
• Criminal actions (including those by
gangs) and penalties
• Confiscation
• Extradition of criminals
• Mutual legal assistance
• Close international cooperation
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New category:
• Introducing substances that can be
used in production of narcotic drugs
and psychotropic substances
(precursors)
• Thes in Schedules I and II
• Control measures against diverting
them from licit to illicit use
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Precursor control
• persons and enterprises, control and
authorisation to establish the latter
• to hinder accumulation of stocks not
needed for normal activities
• documented export/import, to be
sent to competent foreign authorities
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Schedules
• Scheduling of substances: similar
mechanism similar to narcotics and
psychotropic ones
• Schedule I: starting materials
• Schedule II: chemicals often used for
manufacture of narcotic and
psychotropic substances
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Schedule I (examples)
(typical starting materials)
…ephedrin, pseudoephedrin,
ergometrin, ergotamin, safrol,
isosafrol, lizergic acid...
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Schedule II (examples)
(often used chemicals)
…aceton, acetic anhydrid, diethyl
ether, potassium permanganate,
sulfuric acid, piperidine, hydrochloric
acid, toluene...
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This is the principle
It is almost sure that a local
law gives more concrete
measures. Identify it!
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The rather because it may
have consequences to the
activities of pharmacies!
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„Precursor” law
Definitions
• What are the controlled substances
(probably those scheduled in the UN
Convention, except mixtures they can
not simply re-gained)
The competent authority that decides whether
a concrete mixture is under control or not
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Documentation
• General requirements covering all
activities (import, export, production,
selling, storage, even agents)
• Differences for
Schedules/substances?
• Quantity limitations (e.g. used
annually)?
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Purchaser Declarations
• Introduced by many countries
• Needed when buying precursors
(Purchaser, substance, quantity,
declaration about the named licit use,
declaration that such declaration will be
requested when re-selling, etc.)
• Differences according to
Schedules/substances/quantitites?
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(Documentation, followed)
• Often label requirements for
Schedule I, sometimes also for some
Schedule II
• All kind of documentation stored for
a specified period of time
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Production, storage
• Pre-authrisation? Notification?
• Differences according to
Schedules/substances/quantities?
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(excemption for pharmacies?)
Typical: exempted, if precursor is
• used for compounding (magistral)
drugs in pharmacies
• purchased from drug wholesale
licence holders in smaller annual
quantities than specified in the law
ready pharmaceutical preparations
(dosage-forms) are, as a rule, not
precursors
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Statistical reporting mandatory for
pharmacies?
• If so, for which
Schedule/substances?
• Content
• Retrospectively, also prospective
estimations? Frequency?
• to whom? (MoH, MoInt., Public
Health Service, Police, etc.)
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Controlling authorities?
• Ministry, Police, Customs authority.
Public Health Service...
• Who inspects precursor storage and
handling in pharmacies?
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Waste
• Is it controlled? If so, which
documentation, reporting, timeschedules?
• Whom to report, notify?
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Hungarian examples from
the real life
Physicians/vet.s, with their professional ID
may purchase some drugs in pharmacies
Could they buy also ephedrine substance
in a community pharmacy?
No, for...
…first, ephedrine has no medicinal use as
undivided powder (it would be enough,
but) second, it is also Schedule I
precursor!
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(KMNO4 in Hungarian community
pharmacies)
Exempted from the detailed
documentation requirements? (Purhase:
invoices, use: compounding record,
poison-like documentation, selling:
invoice plus purchaser declaration if >5
kg)
• Schedule II substance
• If annual stock of the pharmacy is <5 kg:
yes!
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Exam topic
Regulation of narcotic issues
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Which Convention regulates it
Its Preamble and definitions: narcotic, illicit, ECOSOC, INCB
The Schedules with examples
The role of the WHO
The tasks of the INCB
Estimates and statistics
Limitations on manufacture and import
The Parties’ annual report
Provisions to cultivation
Responsible person
Inspections/controls
Describe the situation in your country
Regulation of psychotropic
issues
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Which convention regulates it
Definition of a psychotropic substance
Similarities to the Single Convention
Psychotropic Schedules with examples
General limitations, records, international
trade
• Statistics
• Describe the situation in your country
Regulation of precursor
substances
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Which Convention regulates it
What are the precursors
Schedules with examples
Why stricter measures are needed for
these materials
Content of the precursor control
What is Purchaser Declaration
Controlling authorities
Precursors and pharmacy administration