Establishment licence holder

Following the entry into force of the new Therapeutic Products Act (TPA, SR 812.21) and the revised Medicinal Products Licensing Ordinance (MPLO, SR 812.212.1), establishment licences granted from 1 January 2019 have been issued under the new legislation.

Holders of establishment licences issued under the new legislation appear in the following list:

  • “Establishment licences issued under the new legislation”.

Establishment licences issued under the old legislation will retain their validity until their expiry date.

Holders of establishment licences issued under the old legislation appear in the following list:

  • “Establishment licences issued under the old legislation”.

During the transitional period lasting until all establishment licences issued under the old legislation and not renewed under the new legislation have expired, it should be borne in mind that a licence holder may appear in either of the two published lists.

Blood and labile blood products
With the entry into force of the new legislation on 1 January 2019, establishment licences for activities with blood and labile blood products were integrated into the general approval process for medicinal products. Under the new legislation, licence holders for these activities will therefore be included in the general list:

  • “Establishment licences according to the new legislation”

Establishment licences issued under the old legislation will remain valid until their expiry date. Concerned licence holders are included in the following list:

  • "Establishment licences for the handling of blood and labile blood products according to the old legislation”

This list does not include facilities that possess a cantonal licence for the storage of blood or blood products.

Legal basis
Pursuant to Articles, 5, 18, 28 and 34 of the Therapeutic Products Act (TPA, SR 812.21), companies that:

  • manufacture or trade in medicinal products
  • act as a trader in or agent for medicinal products

are required to hold an establishment licence issued by Swissmedic. Swissmedic (blood and blood products are also considered to be medicinal products). Those who draw blood from persons in order to use or forward it for transfusions or for the manufacture of therapeutic products require an establishment licence from Swissmedic (Art. 34 para. 1 TPA). However, companies that only store blood or blood products require an establishment licence from the canton (Art. 34 para. 4 TPA).

Company names and registered offices
The company names and addresses that appear in this list are those entered in the Commercial Register. Incidentally, establishment licences are always made out in the name of the legal entities listed in the Commercial Register (if such an entry exists). 

Date of validity of establishment licences and pending applications
The “Date” column in the “Establishment licences issued under the old legislation” list shows the expiry dates of establishment licences issued under the old legislation.
In most cases, establishment licences issued from 1 January 2019 under the new legislation are valid for an unlimited period.

Validity
Establishment licences are the sole legally authoritative documents. Suppliers and customers must therefore always inspect their business partners’ establishment licence. The lists are published solely for information purposes and do not in any way absolve suppliers and customers from their duty to exercise due care, especially in view of the fact that the lists do not mention certain restrictions.
If an activity has been erroneously assigned to a company in one of the lists, the company in question cannot demand that Swissmedic issue or uphold a licence for this activity.

Errors

If you notice a mistake in the list, please write to:

Swissmedic
Inspectorate and Licenses
Hallerstrasse 7
3012 Bern
Switzerland

inspectorates@swissmedic.ch