Guidelines for national competent authorities

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Preparing Statistical Reports on Psychotropic Substances: Guidelines for
National Competent Authorities
These brief guidelines should facilitate the preparation of statistical reports that
national competent authorities are required to submit to the International Narcotics
Control Board (INCB) in accordance with the provisions of the Convention on
Psychotropic Substances of 1971 (referred to in further text as “1971 Convention”)
and the relevant ECOSOC and CND resolutions. The guidelines should be used in
conjunction with the Training Material: Control of Psychotropic Substances, which is
also available on this website. The guidelines have the form of responses to frequently
asked questions:
Question 1: What are the psychotropic substances under international control?
Question 2: Which forms should be furnished to INCB?
Question 3: Where can I find the forms?
Question 4: Where can I find advice on how to fill in the forms?
Question 5: What statistics shall be reported to INCB?
Question 6: What should I be particularly aware of when preparing the reports?
Question 7: Which information is most frequently omitted from the reports?
Question 8: What are the most frequent mistakes in reporting to INCB?
Question 9: Why is the high quality of my reports so important?
Question 10: Are my reports reflected in any publications?
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Question 1: What are the psychotropic substances under international control?
Please refer to the list of psychotropic substances under international control, known
as the “Green List”. The list includes all psychotropic substances in Schedules I, II, III
and IV of the 1971 Convention, their names, synonyms and trade names, their salts
and preparations containing psychotropic substances under international control. It
also contains the conversion factors of pure anhydrous base content of psychotropic
substances, as well as the prohibition of and restrictions on export and import
pursuant to article 13 of the 1971 Convention on psychotropic substances. The green
list is updated periodically and available on the INCB website.
Question 2: Which forms should be furnished to INCB?
All national competent authorities shall submit to INCB the following forms
containing the statistical information that Governments are required to report to the
Board, pursuant to the provisions of the 1971 Convention and the relevant ECOSOC
and CND resolutions.
Form P:
should be submitted by 30 June of the present year for statistics of the
previous year (for example, a form P must be submitted by 30 June 2012 to report
statistics of the year 2011).
Form A/P:
should be submitted to INCB four times a year, not later than one
month after the end of the quarter to which it relates, i.e. by 30 April (for the first
quarter), 31 July (for the second quarter), by 31 October (for the third quarter) and by
31 January of the next year (for the fourth quarter). The submission of form A/P is not
required for countries and territories that have never imported substances listed in
Schedule II.
Form B/P:
A fully revised form should be submitted at least once every three
years. Modifications of individual assessments can be submitted anytime as
necessary.
Forms
Name
Frequency of
submission
Form P
Annual statistical
report on
psychotropic
substances
Annually
Form A/P
Quarterly statistics Quarterly
on imports and
exports of
psychotropic
substances listed in
Schedule II of the
1971 Convention
Submission date
30 June each year
End of each quarter
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Form B/P
Assessment of
At least once
annual medical and every
scientific
3 years
requirements for
psychotropic
substances listed in
Schedules II, III
and IV of the
1971 Convention
No fixed deadline
Modification of
individual
assessments
Any time
As necessary
Question 3: Where can I find the forms?
All forms can be downloaded from this website under Forms. In addition, INCB sends
circular letters at the beginning of each year to national competent authorities
attaching the forms. You can request additional hard copies by sending an e-mail to
the INCB Secretariat (secretariat@incb.org).
Question 4: Where can I find advice on how to fill in the forms?
The INCB Training Material: Control of Pyschotropic Substances is available on the
INCB website Psychotropic Substances. It contains detailed guidelines and examples
for reporting statistics on Form P, Form A/P , and Form B/P. Please refer to Part II of
the Training Material for detailed information. Instructions are also given on each
form. In addition, you will find useful information contained in the List of
Psychotropic Substances under International Control (Green List). Should you have
any questions , you may wish to send an inquiry to the INCB Secretariat
(secretariat@incb.org). We will endeavour to respond to you as soon as possible.
Question 5: What statistics shall be reported to INCB?
The following table summarizes the statistics to be reported to INCB:
Forms
P
P
P
1
2
Statistics
Quantity manufactured
Quantity used for the
manufacture of nonpsychotropic substances or
products
Quantity used for the
manufacture of other
psychotropic substances
Quantity used for the
Mandatory
Voluntary
Not
applicable
All schedules
Schedules I1, II,
III and IV
Schedules I2, II,
III and IV
Schedules II and
If applicable, although not foreseen in the 1971 Convention.
If applicable, although not foreseen in the 1971 Convention.
Schedule IV
Schedule I
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P
P
P
manufacture of preparations
exempted under article 3,
paragraphs 2 and 3
Manufacturers’ stocks as at 31
December
Total imports
Total exports
Details on imports
P
Details on exports
P
Quantity consumed
P
A/P
B/P
Quarterly statistics on imports
and exports
Assessments of annual
legitimate requirements
III
Schedules I and
II
All schedules
All schedules
Schedules I and
II
Schedules I and
II
Schedules III
and IV
Schedules III
and IV
Schedules III
and IV
Schedules I, II,
III and IV
Schedule II
Schedules II,
III and IV
Schedules I, III,
and IV
Schedule I
Form P
All national competent authorities shall report on Form P annual statistical data on
imports, exports and consumption of psychotropic substances. Total annual imports
and exports of psychotropic substances listed in all Schedules of the 1971 Convention
shall be reported on Form P including details on international trade, indicating the
quantities imported and countries of origin of imports, as well as the quantities
exported and countries of destination of exports.
Countries that manufacture psychotropic substances should report on Form P the total
quantity manufactured domestically for all psychotropic substances, and the quantity
held in stock by manufacturers on 31 December of the year to which the statistics
relate. Other information, such as statistics on quantities used for the manufacture of
other psychotropic substances or quantities used for the manufacture of preparations
exempted under article 3, paragraphs 2 and 3, of the 1971 Convention, should also be
reported on Form P as applicable.
Pursuant to CND resolutions 53/4 and 54/6, Governments are requested to provide
data on the consumption of psychotropic substances on a voluntary basis. For each
substance listed in Schedules I to IV, the reporting authority should indicate (in grams
or kilograms, as applicable) the quantity consumed during the year in question, i.e.,
the quantity supplied by a manufacturer or wholesaler to any person or enterprise
(pharmacists, hospitals, etc.) for retail distribution, medical use or scientific research.
Please refer to the Training Material, paragraphs 78 to 106 for further explanations.
Form A/P
All imports and exports of psychotropic substances included in Schedule II shall be
reported to INCB on Form A/P on a quarterly basis. It may happen that no
psychotropic substances were imported/exported during the quarter to which the
respective Form A/P relates. In such case, the form should still be furnished to INCB
indicating that no imports and exports took place during the respective quarter. Small
quantities, such as less than 1 gram, should also be reported.
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If not all required information is available to you by the deadlines of submission of
the forms, please furnish the available information and indicate in the “Remarks”
section of the cover page of the form as to what information is missing, why and
when it can be submitted.
Please refer to the Training Material, paragraphs 107 to 112 for further explanations.
Form B/P
Governments should ensure that psychotropic substances are available for legitimate
purposes in their countries and territories. Therefore, Governments should establish
assessments of the annual legitimate requirements of psychotropic substances for
medical and scientific use in their countries and territories. Form B/P is established by
INCB to obtain from Governments such information for psychotropic substances
listed in Schedules II, III and IV. Substances in Schedule I have no medical use;
therefore the submission of assessments is not required from Governments. The
assessments should include quantities to be manufactured domestically and imported.
It should be indicated on the form if quantities for export or re-export are included in
the total amount. Quantities needed for industrial purposes (i.e. to manufacture other
substances) should also be reported.
A new Form B/P submitted to INCB reflects a full review of the current assessments
of annual legitimate requirements for ALL psychotropic substances used in the
country. The newly communicated quantities will replace the previous ones submitted
to INCB and any subsequent modifications to those submissions. Unlike the estimates
of legitimate requirements for narcotic drugs for medical and scientific purposes, the
assessments for psychotropic substances are not required to be confirmed by INCB.
The same form may also be used to submit modifications to the current assessments
of ONE or MORE psychotropic substances or to submit assessments for additional
psychotropic substances, by marking the box “Modification” on form B/P. The
revised total assessments should be indicated and NOT the quantities in addition to
the previous assessments. Information on assessments for psychotropic substances are
updated on a monthly basis on the INCB website (www.incb.org) and distributed
quarterly.
Please refer to the Training Material, paragraphs 113 to 137 for further explanations.
Question 6: What should I be particularly aware of when preparing the reports?
Some terms used in the 1971 Convention have special definitions, which may be
different from their usual meanings in daily life. In order to prepare the correct reports
to INCB, you have to be aware of the exact meanings of these terms/concepts as
explained in the 1971 Convention (Article 1, Use of terms) and in the Training
Material.
For instance, the term “manufacture” under the 1971 Convention refers to all
processes by which psychotropic substances may be obtained, including the
separation of psychotropic substances from a plant, refining, and transformation of
psychotropic substances into other psychotropic substances. It also includes the
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quantities of psychotropic substances contained in pharmaceutical preparations that
are manufactured using non-psychotropic starting material. On the other hand, in
order to avoid double counting, if a country manufactures a psychotropic substance in
bulk form, which is then used to manufacture pharmaceutical preparations containing
that substance, then only the manufactured quantity in bulk form should be included
in the reporting and not the quantity of substance contained in the preparations. The
Training Material (paragraph 81 to 82) provides detailed explanations on the
quantities of manufacture that should be reported under the 1971 Convention.
Statistics on “stocks” refer to those held by manufacturers of psychotropic substances
and should not include stocks of pharmaceutical preparations at the wholesaler or
retail level.
The term “consumption” also entails a specific meaning. It refers to the quantity
supplied by a manufacturer or wholesaler to any person or enterprise (pharmacists,
hospitals, etc.) for retail distribution, medical use or scientific research. Paragraph 97
to 99 of the Training Material provide detailed explanations and examples about this
term.
Imported and exported quantities of psychotropic substances to be reported to INCB
shall include quantities in bulk form (powder, liquid), quantities in pharmaceutical
dosage forms (tablets, ampoules) and quantities imported in finished pharmaceutical
products (pharmaceutical preparations containing psychotropic substances already
packed and labelled).
Quantities of psychotropic substances reported to INCB should be expressed in terms
of the pure anhydrous content of the psychotropic substances. The Training Material
(paragraph 72) provides explanations on how to indicate quantities of psychotropic
substances in the forms furnished to INCB. Part Three of the List of Psychotropic
Substances under International Control (“Green List”) contains a table showing the
conversion factors into pure anhydrous base content of psychotropic substances listed
in all schedules of the 1971 Convention.
Question 7: Which information is most frequently omitted from the reports?
Any omission to submit requested information to INCB creates a problem and
requires additional correspondence between INCB and the national competent
authority to clarify the matter.
The most frequent omissions are as follows:
Form P - Information on trade in psychotropic substances is often incomplete: trade
details of each substance should contain not only the total quantity traded in the year
in question but also the breakdown by the countries of origin/destination and the
corresponding quantities. Some authorities fail to provide information on stocks held
by manufacturers and the quantities used for industrial purposes.
Form A/P - Some authorities fail to indicate the breakdown of quantities by
country/countries from where the substance has been imported and/or to where the
substance has been exported;
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Form B/P - Some authorities fail to indicate the quantities for export or re-export.
Question 8: What are the most frequent mistakes in reporting to INCB?
In general, the mistakes happen most frequently in the following areas:




Double counting;
Wrong unit of measurement (grams or kilograms);
Entry of data to a wrong column;
Wrong country names or substances names.
Form P - Statistics on manufacture should include the quantity of psychotropic
substances contained in the pharmaceutical preparations that are manufactured using
non-psychotropic starting material. If the quantity of a psychotropic substance
manufactured in bulk form has been included in the manufacture statistics, then the
quantities of the pharmaceutical preparations manufactured from that substance
should not be included in the statistics, in order to avoid double counting. Statistics on
stocks should only include those held by manufacturers of psychotropic substances
and not the stocks of pharmaceutical preparations held at the wholesaler or retail level.
Quantities of psychotropic substances indicated in all forms should not be expressed
in terms of esters, ethers or salts, but in terms of the content of pure psychotropic
substance.
Form P and Form A/P- A psychotropic substance shall be reported as imported only
when it has actually arrived in the importing country/territory (physical transfer). The
issuance of an import certificate is not sufficient for the quantity to be included in the
import statistics, if the import is not effected. Similarly, the issuance of an export
authorization is not sufficient for the quantity to be included in the export statistics.
The reported quantity should reflect the actual quantity imported or exported.
Form B/P – Entry of data into the wrong column of unit of measurement (grams or
kilograms) and incorrect use of comma(,) or decimal point (.) when presenting the
numbers. This may require further clarification with the authorities. Very often there
is no indication as to whether the assessments include quantities for export or reexport. Sometimes the assessments do not include the quantities manufactured
domestically.
Question 9: Why is the high quality of my reports so important?
Timely and complete submission of all statistical reports to INCB by national
competent authorities is very important for the proper functioning of the international
drug control system as a whole, and the control of psychotropic substances in each
individual reporting country/territory.
Assessments of annual requirements of psychotropic substances published by INCB
indicate the maximum quantities of psychotropic substances that individual countries
and territories may manufacture domestically and import in a year. The Parties should
verify that exports of psychotropic substances to any country or territory are within
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the established assessments for that country or territory. Appropriate assessments are
therefore important to ensure adequate availability of psychotropic substances for
legitimate uses.
Failure by a national competent authority to provide statistical reports to INCB, or
frequent mistakes and inconsistencies in reporting, may indicate weaknesses in the
implementation of the provisions of the 1971 Convention in a country. In accordance
with its treaty mandate, INCB has to bring such situation to the attention of the
Government concerned in order to ensure proper implementation of the treaty
provisions. Failure by a national competent authority to furnish statistical reports is
also reflected in INCB publications (see answer to Question 10).
INCB uses information received from national competent authorities for various
studies and analyses, including the assessment of the effectiveness of national control
measures. The quality of these studies and analyses depends to a large extent on the
data available. For example, by analyzing reports on international trade received from
Governments, INCB may identify diversion attempts of psychotropic substances from
licit trade into illicit traffic. Failure by any national competent authority to provide
complete and accurate reports on international trade in psychotropic substances makes
the identification and prevention of diversion attempts more difficult.
Question 10: Are my reports reflected in any publications?
The status of submission of statistical reports for psychotropic substances by all
countries and territories is reflected in Chapter II of the INCB annual report and in
Part I of the INCB annual technical publication Psychotropic Substances - Technical
Reports. The latest statistics submitted by Governments are contained in Part II of the
technical publication. The assessments of annual legitimate requirements for
psychotropic substances are shown in Part IV of the publication. Part III of this
publication shows consumption levels of psychotropic substances calculated by the
Board based on the statistics submitted by Governments. Past issues of the technical
publication are available on the INCB website. You may wish to check whether the
data reported by you were correctly included in the respective tables of this
publication and inform the INCB secretariat of any discrepancies between your
reports and the data published.
The assessments for psychotropic substances of all countries and territories are
updated monthly on the INCB website (www.incb.org) in the section “Assessments
for Psychotropic Substances”. Hardcopies are distributed quarterly.
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