Page 140 WHO - Guidelines on the pharmacological treatment of persisting pain in children with medical illness

Import and export authorizations are normally required for each shipment. 3

The authorization process for the importation and exportation of opioid medicines can be very A1
lengthy and subject to errors. Therefore, the procurement of controlled medicines requires
careful planning.

Managers and officers involved in the procurement of opioid analgesics should use the steps
outlined here as a starting point to develop comprehensive plans specific to their countries’
situations. Since the importation of controlled medicines involves decision-making and
authorizations from several departments/agencies, it is crucial that strong coordination and A2
partnerships are established among all parties.

A6.10 The reporting system following exportation,
importation and consumption of opioids

The competent national authority in the country must send quarterly reports to the INCB of all imports A3
and exports of opioid analgesics classified under Schedule I. It is also mandatory to make an annual
inventory and report the total amount of opioids manufactured, consumed and held in stock at central
level (e.g. licensed central warehouses, manufacturers’ warehouses). The annual inventory does not
include medicines stored in retail pharmacies, retail distributors or other health services which, for
official purposes, are considered to have been consumed. 4

A6.11 Distribution of strong opioids A4

The Single Convention requires countries to ensure that trade and distribution can be performed only by
licensed parties. The competent national authority normally provides trade and distribution licences for
private companies, either manufacturers or wholesalers. A manufacturer or wholesaler may distribute
the finished products directly to licensed pharmacies or hospitals. Wholesalers must also be licensed by
the competent national authority, and must comply with rules concerning security and record keeping.
The Single Convention neither requests countries to provide exclusive rights for the storage, distribution A5
and trade of controlled medicines to one single state agency or private company, nor suggests that
opioids be managed within a special or separate medicine distribution system.

However, some countries have separated the storage and distribution of controlled medicines from the
distribution system for other medicines. They have also established additional requirements to those
mandated by the Single Convention. These may sometimes have a negative impact on the accessibility to
strong opioids and increase distribution costs.
A6

A7

3 One import authorization can allow for more shipments (for which exportation authorization needs to be granted
on a single basis).
4 “Stock” is defined in Article 1 of the Single Convention on Narcotic Drugs 1961 as amended by the 1972
Protocol.

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