Import and export of narcotics

The import and export of narcotics is subject to licences issued by the Icelandic Medicines Agency (IMA), cf. Article 6 of the Regulation on Habit-forming and Narcotic Substances and Other Controlled Substances, No. 233/2001 (in Icelandic only). The cost of each licence is in accordance with IMA's tariff of fees.

Import

Companies holding a licence to import medicinal products can apply to import narcotics by written application.

The licence is issued in triplicate: one copy is sent to the exporter so that an export licence can be obtained in the exporting country, one copy is used to clear the narcotic through customs, and the last copy is returned to IMA after import.

The copy sent to IMA shall contain information on the quantity of substance imported and the date of import, and if less is imported than originally applied for, the reason must be given. If the licence is not used, it shall be sent to IMA no later than the date on which the licence expires.

Export

Companies holding a licence to manufacture or wholesale distribute medicinal products can apply for a licence to export narcotics by written application.

The licence is issued when the exporter has sent IMA an import licence from the authorities in the importing country together with the application for an export licence.

The licence is issued in triplicate: one copy is sent to the importer, one copy is used to clear the narcotic through customs, and the last copy is returned to IMA after export.

The copy sent to IMA shall contain information on the quantity of substance exported and the date of export, and if less is exported than originally applied for, the reason must be given. If the licence is not used, it shall be sent to IMA no later than the date on which the licence expires.

Applications

A licence must be applied for for each consignment of narcotics imported or exported, via an electronic form on Ísland.is or IMA's My pages.

Only companies holding a licence to import medicinal products can apply for a licence to import or export narcotics. IMA points out that the applicant is responsible for ensuring that the information in the application is correct. An application for an export licence shall be accompanied by an import licence from the importing country.

IMA usually processes applications for import and export licences for narcotics within one week of receipt.

Issued import and export licences are sent by post from IMA on Tuesdays. Every effort is made to issue all licences received before Tuesday, but processing of applications received on Thursday or later cannot be guaranteed before the following Tuesday.

Reports

Every quarter, IMA sends a report to the International Narcotics Control Board (INCB) with information on the quantities of narcotics imported into or exported from the country, based on confirmed import and export figures.

At the end of each year, IMA writes to those who have been granted import or export licences for narcotics, requesting information on their stock of narcotics at the year end and on the import, export and disposal of narcotics during the preceding year. This information is used in preparing the annual report to the INCB and as a basis for the application for a narcotics quota from the INCB.

Request for expedited processing

Expedited processing can be requested by sending an enquiry via Contact us on IMA's website.

• Select a topic from the list: Import or export licence, as applicable.

• As the "Subject", write: "Urgent – request for expedited processing of licence application"

• In the message: State which medicinal product the application concerns and whether you wish to collect the licence or have it sent by post.

The applicant will be notified by email when the licence is ready.

Request to collect an import or export licence

A request to collect an issued licence can be made by sending an enquiry via Contact us on IMA's website.

• Select a topic from the list: Import or export licence, as applicable.

• As the "Subject", write: "Urgent – request to collect licence"

• In the message: State which medicinal product the application concerns and when you wish to collect the issued licence.

The applicant will be notified by email when the licence is ready.

Import of controlled substances

The import of controlled substances is subject to an import certificate issued by the Icelandic Medicines Agency (IMA), cf. Articles 6 and 7 of the Regulation on Habit-forming and Narcotic Substances and Other Controlled Substances, No. 233/2001 (in Icelandic only).

Those intending to import substances marked DI and DII in the regulation can apply for an import certificate from IMA.

IMA issues import certificates, which are valid for import for the remainder of the calendar year, except for ephedrine and pseudoephedrine, for which a licence must be applied for each time the medicine is imported.

At the end of each year, importers shall send IMA information on the quantities imported during the preceding year.

Importers must provide IMA with information on sales of controlled substances if IMA requests it.

IMA does not issue an import certificate until the importer has sent IMA information on the import and sale of controlled substances during the preceding year.

Applications

Licences to import controlled substances are applied for once a year, and all licences expire at the end of the year regardless of when they were applied for.

There is one exception to this: an application must be submitted for each import of pseudoephedrine.

Applications for import licences are completed electronically. The cost of each licence is in accordance with IMA's tariff of fees.

Published subject to errors and omissions.

Calculation of pure substance

The Medicinal Product Information Catalogue (Sérlyfjaskrá) gives the exact content of either the salt or the pure substance in medicinal products. This information can be found in section 2 of the Summary of Product Characteristics (SmPC).

This page shows how the strength of pure substance is calculated, depending on the type of strength information given.

Declared amount of pure substance

If the quantity of pure substance is declared, it must be recalculated up to the quantity to be imported.

Example: Subutex 8 mg tablets, 7 tablets, 100 packs are to be imported.

Sérlyfjaskrá states that each tablet contains 8 mg of buprenorphine.

• 8 mg/tablet * 7 tablets/pack * 100 packs = 5600 mg

• 5600 mg / 1000 mg/g = 5.6 g of pure buprenorphine.

Declared amount of salt

If the quantity of salt is declared, the conversion factor must be obtained from the website of the INCB (International Narcotics Control Board).

The conversion factors are given in three lists. The INCB divides narcotic and habit-forming substances into two categories and controlled substances into one category:

• The yellow list contains narcotic drugs,

• the green list contains psychotropic substances

• the red list contains controlled substances (precursors).

These lists contain the conversion factors used to determine the quantity of pure substance. In the yellow list the conversion factors are in Part 4, and in the green and red lists they are in Part 3.

Example: Contalgin 20 mg, 28 tablets, 100 packs are to be imported

Sérlyfjaskrá states that each tablet contains morphine sulfate.

Part 4 of the yellow list states that the conversion factor for morphine sulfate is 75, which means that 75% of morphine sulfate is pure substance.

• 20 mg/tablet * 0.75 * 28 tablets/pack * 100 packs = 42000 mg

• 42000 mg / 1000 mg/g = 42 g of pure morphine.