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? -2- 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 -3- 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 -4P 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. -5- 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 -6- 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; -7- 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 -8- 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. ************************