Basic information
Outline of the system
The Federal Office of Public Health (OFSP, https://www.bag.admin.ch/bag/fr/home.html) is the body responsible for authorizing the import of unmanipulated organs, tissues and cells of human origin (other than transplant products) intended for transplantation into humans. The Transplantation Law seeks to guarantee the safe handling of transplant products, in particular with a view to protecting donors and recipients.
Product coverage
An authorization is required for the import of allogeneic organs, tissue and cells of human origin intended for transplantation into humans. This concerns the following Swiss customs tariff number (HS 2017): 3001.9000.
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
There is no restriction on the quantity and value of the products imported.
Questions for products under restriction as to the quantity or value of imports
Not applicable (no quantitative restrictions).
The system applies to products originating from which country?
All countries.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
The Federal Law of 8 October 2004 on the transplantation of organs, tissues and cells (Transplantation Law; RS 810.21, https://www.admin.ch/opc/fr/classified compilation/20010918/index.html), which entered into force on 1 July 2007. The import procedures are described, inter alia, in the Ordinance of 16 March 2007 on the transplantation of human organs, tissues and cells (Transplantation Ordinance; RS 810.211, https://www.admin.ch/opc/fr/classified compilation/20051806/index.html).
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
The legislation does not authorize the administration to decide which products will be subject to licensing.
Is it possible for the government to abolish the system without legislative approval?
The government is authorized to revise the Ordinance.
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 are eligible to apply for an import authorization provided that they are domiciled in Switzerland.
Is there a registration fee?
Is there a published list of authorized importers?
Lists of the authorizations issued are published online at: https://www.bag.admin.ch/bag/fr/home/gesetze und bewilligungen/gesuche bewilligungen/gesuche bewilligungen bereich transplantation.html.
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?
What documents is the importer required to supply with the application?
Different documents and certificates may be requested, depending on the type of transplant (according to application and corresponding checklist, available on the transplantation declaration and authorization web page of the OFSP, https://www.bag.admin.ch/bag/fr/home/gesetze und bewilligungen/gesuche bewilligungen/gesuche bewilligungen bereich transplantation.html). A pre authorization inspection is mandatory.
Window of submission of an application
How far in advance of importation must application for a licence be made?
Import is not allowed without authorization. The authorization procedure takes about four months.
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?
No.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
In exceptional cases a shorter procedure can be envisaged.
Which administrative body is responsible for approving application of licences?
The OFSP is the sole organ responsible for examining applications.
Must the applications be passed on to other organs for visa, note or approval?
The OFSP is the sole organ responsible for examining applications.
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 500 to 2,000 per authorization (in addition to inspection).
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?
Only if the applicant does not meet the criteria is an authorization refused.
Are the reasons for any refusal given to applicants?
The reasons will then be stated in the pre authorization inspection report.
Have applicants a right of appeal in the event of refusal to issue a licence?
The decision may be appealed to the Federal Administrative Court and, at second instance, to the Federal Supreme Court.
If so, to what bodies and under what procedures?
The decision may be appealed to the Federal Administrative Court and, at second instance, to the Federal Supreme Court.
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?
Once the authorization is issued, none (for importation).
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?
The period of validity of the authorization is a maximum of five years with the possibility of renewal.
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?
No.
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.