(06.03.2017, 350 KB, XLS)
Explanations / Legend
|A||Production of intermediate products and ready-to-use medicinal products|
|Ax||Production of active pharmaceutical ingredients|
|Bex ||Import without market release of medicinal products|
|Bin||Import including market release of medicinal products|
|Cex||Wholesale without market release of medicinal products|
|Cin||Wholesale including market release of medicinal products|
|E||Trade of medicinal products in foreign countries|
|N||The company does not carry out the activity marked "N"|
|Y||The company is authorized to carry out the activity marked "Y"|
In accordance with Articles 5, 18 and 34 of the Therapeutic Products Act (TPA, SR 812.21), companies that produce medicinal products or trade in them must obtain an establishment license (authorization) from Swissmedic.
Company name and registered offices
The company names and addresses contained in this list correspond to those entered in the Register of Commerce. The establishment licenses are always issued to the legal entity stated in the Register of Commerce. No branches or sites that do not correspond to the Register of Commerce entry are included in the list.
Validity date of the establishment license and pending applications
The column "Datum" contains the validity date of the establishment license. The list also includes companies whose establishment license has expired. Those companies are nevertheless included as long as an application is being processed; the company may continue to operate within the scope of the expired authorization until the process is completed.
Establishment licenses under the former legislation
When the Law on Therapeutic Products was enacted, establishment licenses under the former legislation (establishment licenses issued by cantonal authorities, by the Swiss Federal Office for Public Health and by the Institute for Viral Diseases and Immunoprophylaxis) were subject to a transitional period of validity until 31 December 2006.
The list contains some companies that are still in possession of an establishment license under the former legislation. The activities under the former and the current legislation do not cover exactly the same areas. Only the activities "Production of active substances" and "Production" and "Wholesaling" have been taken up in the list, since they are transferable. The fields for the other activities were left blank, since no statement can be made regarding those activities on the basis of the establishment license under the former legislation.
The printed version of the establishment license is valid. Suppliers and users must examine business partners' establishment licenses. This list does not waive the mandatory diligence they must maintain, since for example any restrictions imposed are not included in the list.
The fact that an activity is shown as authorized in the list does not constitute the legal right to the granting or preservation of this activity.