The fee model for financing the SMVS (Swiss Medicines Verification System) consists of two components:

  • One-time fee for financing the development of SMVS GmbH and the database system.
  • Annual fee to finance the running costs of SMVS GmbH and the database system.


The fees are calculated per pharmaceutical company on the basis of the turnover for RX products and the number of RX packs sold in Switzerland and Liechtenstein.

A pharmaceutical company is defined as follows:

  • A pharmaceutical company is registered as an active company in a Swiss or Liechtenstein commercial register.
  • A pharmaceutical company has one or more Swissmedic Approvals (MAHs) for prescription drugs (Rx products).

Accordingly, the following companies do not fall under the above mentioned definition:

  • A pharmaceutical group that controls several pharmaceutical companies. The organizational form and the degree of integration do not play a role here. In these cases, each pharmaceutical company registers individually with SMVS.


One time fee

The calculation basis for the one-time fee is the last annual turnover of the company for RX products (ex-factory):

Turnover Registration Fee
Rx/Mio. CHF
0 bis 30 10’000.-
30 bis 200 20’000.-
Ab 200 30’000.-
   


Yearly Fee

The annual fee is made up of a fixed amount of CHF 1'500,- which is the same for all companies, plus a share of turnover and volume. The volume share is degressive. This means that the first 50'000 packages cost CHF 0.009 per package, the next 949'999 packages cost CHF 0.007 per package, and so on.

Share of fees related to turnover Volume-related fee share  
Rx turnover ex-factory TCHF Yearly fee
Sold RX Packs
CHF/Pack
0 - 100
0,- 0 - 50'000 0.009
101 - 3'000 2'000.- 50’001 – 1’000’000 0.007
3’001 – 10’000 5'000.- 1’000’001 – 2’000’000 0.005
10’001 – 30’000
15'000.-
from 2’000’001
0.003
30’001 – 50’000
20'000.-    
50’001 – 70’000
25'000.-    
70’001 – 100’000
30'000.-    
100’001 – 150’000
40'000.-    
150’001 – 200’000
50'000.-    
200’001 – 300’000
60'000.-    
from 300’001
70'000.-    
       

 

The access declarations have been sent on June 12, 2018 to the pharmaceutical companies. They are alos available in the download section.

The stated amounts apply according to the above definition per legal entity plus the applicable statutory value added tax.

registration en 

emvologo

 

 

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