Basic information
Outline of the system
An import licence is required for the importation of blood, blood products and immunological products. Swissmedic, the Swiss Institute for Therapeutic Products, is the sole organ authorized to examine licence applications. The aim is to protect human and animal health by guaranteeing that high quality, safe and effective therapeutic products are placed on the market.
Product coverage
A licence is required each time blood, blood products or immunological products are imported. There are exceptions to the requirement, including where batches have already been officially released by an oversight authority that is a member of the Official Control Authority Batch Release (OCABR) network. For the products subject to this procedure and the exceptions to the licence requirement, see the relevant laws and ordinances. The products covered are:
(a) blood and blood products; and
(b) immunological products, such as vaccines, toxins and serums.
This concerns the following Swiss customs tariff numbers (HS 2017): 3002.12, 3002.13, 3002.14, 3002.15, 3002.20, 3002.90.
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?
The regulations apply to imports of all goods, whatever their origin.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
The Federal Law on Medicinal Products and Medical Devices, dated 15 December 2000 (RS 812.21, https://www.admin.ch/opc/fr/classified compilation/20002716/index.html). The procedure for imports is described, inter alia, in the Ordinance of 17 October 2001 on authorizations regarding medicinal products (RS 812.212.1, https://www.admin.ch/opc/fr/classified compilation/20180857/index.html).
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Laws and amendments thereto must be adopted by Parliament. They contain all important provisions. Ordinances contain implementing provisions and must be based on a higher legal authority, a law. In this case, ordinances do not go through Parliament. A licence is required by law for every import of blood and blood products. In the case of immunological products, this requirement is contained in an ordinance.
Is it possible for the government to abolish the system 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?
Institutions wishing to import products subject to licensing must obtain the necessary licence from Swissmedic in accordance with the relevant laws. The licence is granted if the institution meets certain specific operational and organizational conditions (e.g. import, wholesale trade and export authorization, authorization to take blood for transfusions or for the production of medicinal products). Swissmedic regularly controls compliance with these conditions. The procedure for obtaining licences is regulated by the relevant ordinance.
Is there a registration fee?
Is there a published list of authorized importers?
The list of authorized concerns is regularly published (see https://www.swissmedic.ch/swissmedic/fr/home/medicaments a usage humain/bewilligungen_zertifikate/betriebsbewilligungen/titulaire de l autorisation d exploitation.html). Moreover, registered products may only be imported by the institutions in whose name they are registered.
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?
Samples of the application form are available online at https://www.swissmedic.ch/swissmedic/fr/home/services/documents/sang et les produits sanguins labiles.html
What documents is the importer required to supply with the application?
Other certificates may be requested for a more detailed examination of the quality of the products.
Window of submission of an application
How far in advance of importation must application for a licence be made?
In view of the time required to obtain a licence, the application must be submitted a few days in advance of the importation itself.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
No.
Issuing the license
Can a licence be granted immediately on request?
Exceptionally (see above).
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
In normal situations the application is granted and returned within 24 hours of being filed. Exceptionally and in urgent situations, it may be granted upon request by fax.
Which administrative body is responsible for approving application of licences?
Swissmedic is the sole organ authorized to examine licence applications.
Must the applications be passed on to other organs for visa, note or approval?
Swissmedic is the sole organ authorized to examine licence 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?
CHF 100 per licence (see the Ordinance of 2 December 2011 on the fees of the Swiss Institute for Therapeutic Products (RS 812.214.5)).
What is the amount of the fee or charge?
CHF 100 per licence
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?
There are no reasons to refuse a licence application other than failure to meet the specific criteria.
Are the reasons for any refusal given to applicants?
The reasons for any refusal are communicated to the applicant, who has a right to appeal the decision to the administrative authority or to the Federal Administrative Court and, at second instance, to the Federal Supreme Court.
Have applicants a right of appeal in the event of refusal to issue a licence?
The reasons for any refusal are communicated to the applicant, who has a right to appeal the decision to the administrative authority or to the Federal Administrative Court and, at second instance, to the Federal Supreme Court.
If so, to what bodies and under what procedures?
The reasons for any refusal are communicated to the applicant, who has a right to appeal the decision to the administrative authority or 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?
No.
What documents are required upon actual importation?
In addition to the documents usually required by the customs services, only the application form is required. More specific information may be requested in certain cases.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Certain products, such as immunological products or stable blood products, must be registered beforehand by Swissmedic. Moreover, imported batches of registered products are controlled by the Official Medicines Control Laboratory (OMCL) of Swissmedic before being placed on the market, unless they have already been officially released by an oversight authority that is a member of the Official Control Authority Batch Release (OCABR) network.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
The period of validity of the licence is one month, generally without the possibility of extension.
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.