Special Requirements for Narcotic and Psychotropic substances (“controlled substances”)

Some pharmaceutical products – including those used in Opioid Substitution Therapy (OST) programmes – are placed under international control by the United Nations Conventions on Narcotic and Psychotropic substances.

The purchase, export, transportation, import in recipient countries of those products are strictly controlled by the authorities of the exporting and importing countries (“competent national authority”) and by the International Narcotics Control Board (INCB).

Generally, the competent national authority, responsible for liaising with International Narcotics Control Board (INCB) and administering national regulations relating to controlled substances for medical use, is the national drug/pharmaceutical regulatory authority, which is usually part of the Ministry of Health. However, in some countries, this function may lie with another agency such as the Ministry of Interior or Ministry of Justice.

Every year, the competent national authority prepares an estimate of the amount of controlled substances that will be needed in the country during the following calendar year. When approved, the INCB publishes the list of the confirmed estimates for each country. The national estimates confirmed by INCB define the maximum quantity of drugs that a country may acquire through import and/or manufacture. If an annual estimate proves to be inadequate, the competent national authority can submit supplementary estimates to INCB during the course of the year.

Practice Pointer

The importation of controlled substances involves decision making and authorization from several departments/agencies, and the documentation and approvals required prior to shipping make procurement a slow and bureaucratic process. Therefore, it is crucial that strong coordination and partnerships are established among all such parties and that supply planning occurs well in advance of when the medicines are needed.