Basic information
Outline of the system
The purpose of the authorization system for narcotic drugs and psychotropic substances is to ensure that imports are carried out for the sole purpose of satisfying legitimate medical and industrial needs. Article 5 of the Federal Law on Narcotics of 3 October 1951 (LStup; RS 812.121) stipulates that a special authorization is required from Swissmedic, the Swiss Institute for Therapeutic Products (https://www.swissmedic.ch/swissmedic/fr/home.html), for all imports of narcotic drugs, psychotropic substances and precursors. Depending on the substance involved, Swissmedic may issue single authorizations valid once for import, or general authorizations valid for imports carried out over a specific period of time up to the end of each calendar year. Swissmedic, through its Narcotics Division, is responsible for granting import/export authorizations. More detailed information may be obtained from this body (email address: narcotics@swissmedic.ch).
Product coverage
All substances that are subject to the authorization system appear in the DFI Ordinance on the schedules of narcotic drugs, psychotropic substances, precursors and chemical additives of 30 May 2011 (Ordinance on the narcotic drugs schedules, OTStup-DFI, RS 812.121.11). These goods are classified under the following Swiss customs tariff numbers (HS 2017): See Products.
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
Yes. The purpose of the authorization system is to ensure that imports (or exports) are carried out for the sole purpose of satisfying legitimate medical and industrial needs.
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 regulations apply to imports of all goods, whatever their origin.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
Article 5 of the Federal Law on Narcotics of 3 October 1951 (LStup; RS 812.121, https://www.admin.ch/opc/fr/classified compilation/19981989/index.html) stipulates that a special authorization is required from Swissmedic, the Swiss Institute for Therapeutic Products, for all imports (or exports) of narcotic drugs, psychotropic substances and precursors. Article 7 and Chapter 3 of the Ordinance on the control of narcotic drugs of 25 May 2011 (OCStup; RS 812.121.1, https://www.admin.ch/opc/fr/classified compilation/20101221/index.html) lay down the procedures for the granting of import (and export) authorizations.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
The authorization system is maintained under federal laws. The Government may, however, change certain details of the regime, i.e. the above mentioned Ordinances. There is no delegation of authority to the administration. There is, however, a limited delegation of authority to the Federal Department of the Interior (DFI), because Ordinance 812.121.11 of 30 May 2011 (https://www.admin.ch/opc/fr/classified compilation/20101220/index.html), which includes lists of all controlled substances that are subject to the permit system, is under the authority of the DFI.
Is it possible for the government to abolish the system without legislative approval?
The Government does not have the authority to repeal them.
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?
All persons, firms and institutions may apply for an authorization provided they are holders of a cantonal, DFI or Swissmedic authorization to handle controlled substances or a special OFSP authorization.
Is there a registration fee?
Is there a published list of authorized importers?
Swissmedic publishes the lists of persons, firms and institutions authorized by the cantons in accordance with the OCStup criteria.
Contact point for information on eligibility
Ministry/Authority
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Documentation requirements
What information is required in applications?
The importer sends an application for an import authorization, either written or via the NDS WEB system, listing the products to be imported and the corresponding quantities. A specific form is available on the relevant website.
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?
Not applicable.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
Not applicable.
Issuing the license
Can a licence be granted immediately on request?
Not applicable.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Not applicable.
Which administrative body is responsible for approving application of licences?
Not applicable.
Must the applications be passed on to other organs for visa, note or approval?
Not applicable.
Are there any other conditions attached to the issue of a licence?
No.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
Yes.
What is the amount of the fee or charge?
CHF 100 for a single authorization; CHF 200 for a general authorization (the total quantity to be imported/exported must be indicated in the application for authorization).
Is there any deposit or advance payment required associated with the issue of licences?
No.
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?
Any irregularities, no proven legitimate end use and so on.
Are the reasons for any refusal given to applicants?
In the event of a refusal to issue an authorization, the reasons for refusal are given to the applicant, who has the right to appeal within 30 days to the Federal Department of the Interior.
Have applicants a right of appeal in the event of refusal to issue a licence?
In the event of a refusal to issue an authorization, the reasons for refusal are given to the applicant, who has the right to appeal within 30 days to the Federal Department of the Interior.
If so, to what bodies and under what procedures?
In the event of a refusal to issue an authorization, the reasons for refusal are given to the applicant, who has the right to appeal within 30 days to the Federal Department of the Interior.
Importation
Are there any limitations as to the period of year during which importation may be made?
Not applicable.
What documents are required upon actual importation?
A copy of the authorization issued by Swissmedic must be presented to Customs.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
No.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
Single import authorizations are valid for four months. General import authorizations are valid for 12 months and expire on 31 December of each calendar year.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
No.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Import authorizations are not transferable.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
There are no restrictions on foreign exchange in force.
Is a licence required as a condition to obtaining foreign exchange?
There are no restrictions on foreign exchange in force.
Is foreign exchange always available to cover licences issued?
There are no restrictions on foreign exchange in force.
What formalities must be fulfilled for obtaining the foreign exchange?
There are no restrictions on foreign exchange in force.
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?
The quantities that can be imported (and exported) are limited through a system of estimates coordinated by the UN and its International Narcotics Control Board (INCB). Each country must report its annual needs in narcotic drugs and psychotropic substances to the INCB. If need be, requests for adaptations of the estimates may be submitted to the INCB, which approves them if they are legitimate. The INCB publishes the estimates for all of the countries, and updates them on a monthly basis.
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?
The estimates are sent once a year (for psychotropic substances once every three years) to the INCB. Import (and export) authorizations are issued only if the estimates have not been exceeded. Where they have been exceeded, a request for an additional estimate must be forwarded to the INCB.
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 or export authorizations are granted only to holders of a cantonal or a Swissmedic authorization to handle controlled substances or a special OFSP authorization.
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?
There is no time limit for the submission of applications provided the import or export quantities do not exceed the estimates.
What are the minimum and maximum lengths of time for processing applications?
The time required for granting an import (or export) authorization is ten working days on average, assuming that all of the documentation and other requirements have been met. Where there is no estimate or the estimate is insufficient (a few cases each year), the time limits are extended to as much as one month.
How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Import authorizations are valid from the 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?
As a rule, only Swissmedic considers authorization applications. If need be, Swissmedic cooperates with the cantons or the foreign competent authorities concerned, and the INCB.
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?
Applications are considered in the order in which they are received by the Swissmedic service. If an authorization application is not complete or contains errors, Swissmedic informs the applicant by means of a form indicating the deficiencies in the application.
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?
An import authorization is required for every import of narcotic drugs, psychotropic substances and precursors. Import/export authorizations are only issued upon request.
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?
The importing country is informed of any export authorization granted by receiving a copy of the authorization.
Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
No.