Outline of the system
Licences are issued to control the import of specified narcotic drugs, Psychotropic substances and related chemicals. This system fulfils Iceland’s obligation under three United Nations conventions in relation to restricting the supply of controlled substances to what is necessary to meet medical and scientific need and preventing diversion to the illicit drug market.
The purpose for licensing is to control trade of narcotic drugs, Psychotropic substances and related chemicals according to the ratified United Nations conventions and cover all persons or firms involved in international trade in those substances. The drugs covered are substances listed in addendum I to Regulation on narcotic substances, psychotropic substances and other controlled substances, no. 233 of 2001, with later amendments. This regulation is set according to provision in Article 2 of the Act on controlled substance no. 65 of 1974. The above named addendum includes the drugs and chemicals required to be controlled under the Single Convention on Narcotic Drugs, 1961, and the Convention on Psychotropic Substances, 1971. Regulation regarding control of substances listed in the Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances,1988, has not yet been set. This convention was recently ratified.
An exemption applies in the case of a drug that is imported by a passenger on a ship or aircraft where the drug:
- is required for the medical treatment of the person involved;
- was prescribed by a medical practitioner for the purpose of that treatment;
- was supplied to the person in accordance to the prescription in a legal manner.
Nature of licensing
If Automatic, administrative purpose
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
The use of import licences enables the government to restrict and monitor the quantities of controlled substances imported and is intended to prevent over-supply and diversion of same. The system is based on the requirements of the international conventions.
Questions for products under restriction as to the quantity or value of imports
See answers 6.1-6.11
The system applies to products originating from which country?
The system applies to importers of controlled substance from all countries.
Expected duration of licensing procedure
Is the licensing statutorily required?
The licensing is maintained by the Act on controlled substances no. 65 of 1974, with later amendments, and the Regulation on narcotic substances, psychotropic substances and other controlled substances, no. 233 of 2001, with later amendments, set by provision in above named act. The licensing is statutorily required.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Designation of products to be subjected to licensing (in addition to substances listed in the international conventions) is at administrative discretion.
Is it possible for the government to abolish the system without legislative approval?
The system cannot be abolished without legislative approval.
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
Any person, firm or institution may apply for a licence. A licence will only be granted to holders of a ministerial licence to handle, store and sell controlled substances. Such licence is granted subject to conditions in the Pharmaceutical act and Act on controlled substances and applicant is subject to Icelandic Medicines Control Agency inspections and approval in his operations.
Is there a registration fee?
Is there a published list of authorized importers?
Names of licensed importers are available at the Ministry of Health and Social Security upon request.
Contact point for information on eligibility
Submission of an application
Administrative body(ies) for submission of an application
What information is required in applications?
No official form is needed to apply for a licence but the following information must be submitted:
- Name and address of importer
- Name and address of seller (exporter)
- Name and quantity of controlled substance. In case of combination product the name and quantity of the controlled substance in the combination
- How the goods are to be transported (airfreight, sea freight, air post, etc.)
- What the substance is to be used for (medical, research, etc.)
A separate import licence is required for each shipment of controlled substances.
What documents is the importer required to supply with the application?
Window of submission of an application
How far in advance of importation must application for a licence be made?
When no quantitative limits are in force: No limits.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
When no quantitative limits are in force: Permits may be issued at any time of the year.
Issuing the license
Can a licence be granted immediately on request?
When no quantitative limits are in force: Yes
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
When no quantitative limits are in force: Licences can be issued for goods arriving without one provided importer has licence to handle, store or sell controlled substances.
Which administrative body is responsible for approving application of licences?
When no quantitative limits are in force: The Ministry of Health and Social Security issues import licences upon application. Import licences are issued for each individual shipment without delay.
Must the applications be passed on to other organs for visa, note or approval?
When no quantitative limits are in force: The Icelandic Medicines Control Agency validates documents required for customs handling of each shipment of controlled substances. This validation is based on the previously issued import licence.
Are there any other conditions attached to the issue of a licence?
Fees and other administrative charges
Is there any licensing fee or administrative charge?
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
An application may be refused if: the import would be excessive to national requirements; and other permission is required but has not been obtained.
Are the reasons for any refusal given to applicants?
In the event of refusal the applicant is notified about the reasons and given opportunity for remedy.
Have applicants a right of appeal in the event of refusal to issue a licence?
If so, to what bodies and under what procedures?
Are there any limitations as to the period of year during which importation may be made?
When no quantitative limits are in force: No.
What documents are required upon actual importation?
The import licence for the particular shipment is required validated by the Icelandic Medicines Control Agency (in addition to invoice, bill of lading, etc.)
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
An import licence is valid for 120 days from issue date. If it not used within that period it becomes invalid and is not extended. If necessary a new licence is issued.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Is a licence required as a condition to obtaining foreign exchange?
Is foreign exchange always available to cover licences issued?
What formalities must be fulfilled for obtaining the foreign exchange?
A form has to be filled out with the name and the ID of the importer.
The following questions are only for products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally)
Where is information on allocation and formalities for licences published? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
National import limits for substances controlled by the Single Convention on Narcotic Drugs and some controlled by the Convention on Psychotropic Substances are set by an estimates system administered by the International Narcotics Control Board (INCB) in Vienna. These limits are published regularly for all parties to the conventions.
Estimates of yearly requirements of Psychotropic drugs not requiring import licence are sent to INCB. In cases when import licence for a controlled substance is not required by Icelandic regulation, but exporting country regulation demands it, such a licence is issued upon request.
Is the size of the quota determined: on yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for a fresh licence on a six-monthly or quarterly basis?
Are licences allocated for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate)
Import licences are only issued to persons or firms that have been licensed by the ministry to handle, store or sell controlled substances, issued by the Minister of Health according to the Pharmaceutical Act and the Act on controlled substances. All issued import licences have to be accounted for as to actual usage. Unused licences are deemed invalid. Names of licensed importers are available at the Ministry of Health and Social Security upon request.
From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
What are the minimum and maximum lengths of time for processing applications?
No limits. Applications are processed immediately within reasonable handling time.
How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Import licences are valid for 120 days from date of issue.
Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
The Ministry of Health and Social Security issues import licences upon application. Import licences are issued for each individual shipment without delay if import limits have not been exceeded.
The Icelandic Medicines Control Agency validates documents required for customs handling of each shipment of controlled substances. This validation is based on the previously issued import licence.
If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
First come, first served. No maximum per applicant within set limits for import. No special provision for new importers. All applications are processed immediately.
In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
No bilateral quotas. Export permits from exporting country are not required.
In cases where imports are allocated on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
In cases of exporting country requesting endorsement of their export permits such endorsement is given on a quarterly basis.
Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
No re-export of controlled substances is permitted.