INTERNATIONAL NARCOTICS CONTROL BOARD (INCB)

The International Narcotics Control Board (INCB) is an independent, quasi-judicial expert body established by the Single Convention on Narcotic Drugs of 1961 through the merging two bodies:

• the Permanent Central Narcotics Board, established by the 1925 International Opium Convention, and
• the Drug Supervisory Body, established by the 1931 Convention for Limiting the Manufacture and Regulating the Distribution of Narcotic Drugs.

The INCB consist of 13 members, elected by the Economic and Social Council for a five-years term, with eligibility for re-election. Ten of these members are elected from a list of candidates nominated by governments, while the remaining three are selected from a list of candidates nominated by the World Health Organisation (WHO), based on their medical, pharmacological, or pharmaceutical experience. INCB members serve in an impartial, personal capacity and are independent of their respective governments.

The production and distribution of controlled substances must be licensed and supervised. Governments are required to provide the INCB with estimates and statistical reports on the drug quantities required, manufactured and used, as well as on quantities seized by police and customs. Each year, the INCB publishes data on the illicit trafficking of drugs under international control.

INTERNATIONAL CLASSIFICATION OF NARCOTIC AND PSYCHOTROPIC DRUGS

Approximatively 250 substances are listed in the schedules annexed to the Single Convention on Narcotic Drugs (New York, 1961, amended in 1972), the Convention on Psychotropic Substances (Vienna, 1971), and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (including precursor control) (Vienna, 1988). The aim of this list is to regulate and restrict the use of these drugs based on their therapeutic value, potential for abuse, health risks, and to prevent the diversion of precursor chemicals to illegal drug manufacturers.

Narcotic drugs

Narcotic drugs are classified and placed under international control by the United Nations Single Convention on Narcotic Drugs of 1961, as amended in 1972. This convention limits 'exclusively to medical and scientific purposes the production, manufacture, export, import, distribution of, trade in, use and possession of drugs' (art. 4c).

The Yellow List contains the complete list of narcotic drugs under international control according to 1961 Convention.

The Yellow List is available at: https://www.incb.org/incb/en/narcotic-drugs/Yellowlist/yellow-list.html

Narcotic drugs are classified in four schedules:

To identify the schedule of narcotic drugs and their MSF attribute (Narcotic 1, 2, 3, 4), consult your European Supply Centre website (see below).

Psychotropic drugs

Psychotropic substances are regulated under international control by the 1971 United Nations Convention on Psychotropic Substances. The purpose of this Convention is are again to limit the use of these substances to medical and scientific purposes (arts. 5 and 7).

The Green list contains the list of psychotropic substances under international control according to the 1971 Convention.

The Green List is available at: https://www.incb.org/incb/en/psychotropics/green-list.html

Psychotropic drugs are classified in four schedules:

To identify the schedule of psychotropics drugs and their MSF attribute (Psychotropic 1, 2, 3, 4), consult the website of your European Supply Centre (see below).

Precursors

Precursors are chemicals frequently used in the illicit manufacture of narcotic drugs and psychotropic substances and are subject to international control under the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988.

The Red List contains the list of precursors under the 1988 Convention.

The Red List is available at: https://www.incb.org/incb/en/precursors/Red_Forms/red-list.html

Precursors are classified in two tables with the MSF attribute "DP" (Drug Precursor).

To identify the table of precursors and their MSF attribute (Drug Precursor 1, 2), consult the website of your European Supply Centre (see below).

INTERNATIONAL ORDER OF NARCOTIC AND PSYCHOTROPIC DRUGS

When exporting or importing narcotic or psychotropic drugs, the legislation of all countries involved must be considered.

The exporter typically needs to present an import permit from the destination country to obtain an export permit for these substances.

If importing for re-export (ImpEx) via a third country (e.g. via Kenya for Somalia), the regulations of the third country must also be followed, or the transit regime should be selected.

In some countries, additional controls may apply if these products are considered chemical weapons by the Office of National Security (beyond the oversight of the National Drug Regulatory Authority).

Importing country

Verify the regulations custom clearance procedures with the Ministry of Health, National Medicines Regulatory Authorities (NMRA), etc.

Some countries prohibit the import of narcotics by humanitarian agencies or allow it only in cases of national supply chain disruptions (exceptional import requests).

Import permit for narcotic and psychotropic drugs

An import permit, usually issued by the Department of Narcotics of the Ministry of Health or NMRA, must include at least:

• Permit number
• Date of issue
• Expiry date of this permit: should be at least 3-4 months, date by which importation must take place. Note: in some countries, extension may be possible.
• Name and address of the importer: MSF name only (instead of the medical coordinator) to avoid delays from changes in coordinator. Otherwise the MSF procurement centre has to apply for a new address to the concerned European MoH in case the coordinator changes.
• Name and address of the exporter: verify with your procurement centre or medical department.
• Details of the product: number of units (ampoules, vials, capsules, tablets, oral drops, oral solution, patches or rectal tubes), in letters and numbers, with precise volume, dose, total active ingredient content (in mg or g). Example: one hundred (100) ampoules of fentanyl, 0.05 mg/ml, 2 ml, totalling 10 mg of active ingredient). Ensure proper conversion if the product is a salt (e.g. morphine HCl) as some countries request the base content of the drugs. Example: 40 vials of morphine hydrochloride 10 mg/ml, 1 ml contain 400 mg of morphine hydrochloride, but only 40 x 7.6 mg = 304 mg of morphine base.
• Name and signature of the authority issuing the permit: preferably on official letterhead.

Remarks

• Carefully review import permits for errors before sending, as changes cannot be made after issuance.
• Orders should be placed per full pack quantity as specified on the permit. You can import less than what is specified on the permits but not more.
• Some countries require additional information (e.g. name and address of the manufacturer) or documentation (e.g. Certificate of Analysis, cGMP, Proforma INV, etc.) as this is important for the procurement centre re-order process (if stock (picking) reservation is required for example).
• In some countries, a general import permit must be obtained before applying for a Special Import Permit (regulated items) (e.g. Ethiopia and Nigeria)
• The scanned copy of the import permit can be sent to the procurement centre to begin the export permit process, followed by the hard copy. Some countries require the return of the hard copy after after obtaining the export permit (e.g. Uganda).
• The MSF procurement centre will use the import permit to apply for the export permit to their concerned MoH. The import permit can only be used once for this application.
• Review the website of your procurement centre for specific information on which drugs require an export licence, grouping drugs on a single import permit, number of orders per mission (usually one order for the whole mission instead of one per projec,t and preferably annual due to the time to obtain the import/export permits), how to send the import permit.
• The import permit must be sent direct to your procurement centre (and not the NMRA)

Exporting country (where the order is placed)

Check the instructions on the website of your procurement centre:

• MSF Supply: https://msfsupply.atlassian.net/wiki/spaces/SC/pages/1549598721/Narcotics+and+psychotropic+drugs
• MSF Logistique: https://msfintl.sharepoint.com/sites/SP-BDX-msflog-op-general-info/products-information/chemical-precursors
• https://msfintl.sharepoint.com/sites/SP-BDX-msflog-op-general-info/products-information/psychotropic-narcotic-classified-products

Exceptional cases

In certain situations (e.g., civil war, guerrilla-controlled areas), if the competent authority is no longer operational or not a member of the INCB (e.g. South Sudan), or if the local competent authority is under other authority (e.g., KMCA-Kurdistan Medical Control Agency- for Iraq is under Baghadi authorities) and cannot issue import permits, the responsible pharmacist at each European Supply Centre may negotiate with its ministry and the International Narcotic Control Board in Vienna. This may lead to obtaining a permit to export small quantities of controlled narcotic or psychotropic drugs via WHO Emergency Authorisation Procedure. This procedure is also possible in emergency situations (e.g., natural disasters). A written request signed by the medical director of the MSF section should be sent to the pharmacist responsible for controlled drugs at the MSF procurement centre. The medical coordinator must promptly acknowledge receipt, which is then used for reconciliation with the NMRA associated with the supply centre.

Transportation of narcotic and psychotropic drugs to missions

Transport will generally be by air, as the import permit is typically valid for three months (though it is often longer). The drugs must arrive in the country before the permit expires.

CONTROLLED SUBSTANCES IN THE KITS

A specific module is created for regulated drugs (code ending with "C") for each kit. However, this module is not automatically supplied when the kit is ordered. These regulated products will not be included in the kit or module and must be ordered separately. An import permit for each of these drugs must be sent to the procurement centre.

Note: this applies only to medical items regulated at the supply centre level (those requiring an export permit in the EU). If the product is regulated (narcotic, psychotropic, or precursor) only in the destination country, these items will not be automatically separated by module in the kit. It is the mission's responsibility to screen the kit contents using the detailed Medical Kit List detailed, available on the MSF Catalogues website.

STORAGE AND HANDLING OF REGULATED PRODUCTS IN THE FIELD

It is essential to adhere to the list of regulated drugs and legal requirements in the country, where MSF operates, as we are not exempt from national law. We work with national staff and MSF pharmacies may be subject to inspection by health authorities for evaluation.

In general

• Identify regulated drugs: confirm what is considered a “regulated drug” by the national authorities, as the list may vary from country to country.
• Designate responsible personnel: appoint 2 or 3 people responsible for the movement and tracking of regulated products.
• Maintain written records: all pharmacies should have a written list of regulated drugs.
• Storage requirements: regulated drugs must be stored securely (under lock and key) in accordance with the country's regulations, under the responsibility of the designated personnel. Drugs included in a kit should be identified by the kit name.
• Ensure proper handling: double-check the different steps of handling (reception, packing, authorisation, dispatch, etc.).
• Follow FEFO principle: The "First Expired First Out (FEFO) principle applies to regulated drugs. Ensure expiry dates are regularly checked, especially for drugs in kits.
• Track and report movements: record the movement of drugs in a separate register. National health authorities may require regular written reports of movements and consumption. If required, ensure that stock movements are officially documented.