Page 138 WHO - Guidelines on the pharmacological treatment of persisting pain in children with medical illness

Special reporting to INCB is additionally requested regarding the:
• quantities of opioid medicines to be used in the manufacturing of other medicines; A1
• number of industrial establishments that will manufacture opioid medicines;
• quantities of opioid medicines to be manufactured by each establishment.

A6.8 The import/export system for strong opioids

The principles governing the procurement and supply of strong opioid medicines are similar to other
pharmaceutical products, but require additional steps as mandated by the Single Convention and A2
national legislation.

Generally, each country has its own importation procedures, which may require approval from different
authorities in the country, such as the ministry of health, the national medicines regulatory authority
and other entities (e.g. for import duties).

Specifically, the Single Convention requires additional steps and approvals for the importation and A3
exportation of narcotic drugs. These steps, outlined below and in Figure A6.1 below, are broadly
applicable across countries, although specific requirements may vary from country to country.
1. The licensed importing entity (e.g. private or public company) applies for an import authorization
from the importing country’s competent authority. 2
2. The competent authority considers whether the entity is properly licensed and whether the amount
of drug required is within the national estimate. If so, the competent authority issues an original
import certificate and the appropriate number of copies. The original and one copy are for the A4
importer, one copy is for the competent authority of the exporting country, and an additional copy
is to be kept in the records of the issuing competent authority.

3. The importer sends the original of the import authorization to the company responsible for the
export of the substance.
4. The exporter applies to its competent authority for an export authorization and encloses the import
authorization to the application. A5
5. The competent authority in the exporting country checks that an import authorization has
been issued and that the exporter is properly licensed. If the application is approved, an export
authorization is issued and the original import authorization is returned.
6. The competent authority in the exporting country sends a copy of the export authorization to its
counterpart competent authority in the importing country.
7. The exporter ships the drugs to the importer, along with the copy of the export authorization and A6
the original import authorization.

8. The shipment must pass two customs inspections: one in the exporting country and one in the
importing country.
9. The importer sends the export authorization to its competent authority in the importing country.

A7

2 It should be noted that, while the competent authorities in some countries are different from the national
medicines regulatory authority, in others they may be one and the same authority.

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