Has a health authority prohibited the sale of your pharmaceutical products in Europe, because you are a Swiss established company?
Sale of pharmaceutical products within the EU by non established companies – background
- Recent developments show that health authorities increase audits and prevent the sale of pharmaceutical products within the EU by companies located outside of the EU, if they do not have a correct wholesaler license in place.
- Legal basis: The pharmaceutical legislation, Art. 76 of the directive 2001/83EG, the anti-counterfeiting directive 2011/62 and correspondent legal acts implemented in 2015 in different EU member states
- Consequences/major challenges:
- Restructuring the current Swiss business model
- Significant changes in the supply chain
- Direct and indirect tax implications in Switzerland and in the European Union
- ERP system and contract adaptions
Pharma & Life Science Hot Topics: Sale of pharmaceutical products within the EU by non established companies
Is your pharmaceutical company established in Switzerland?, Do you sell pharmaceutical (end-) products/drugs in the EU?, Is the wholesaler license used issued on the name of another company than that one that sells the products in the EU?
If the answer of all three key questions is yes, we recommend to have your business reviewed and optimized. We have developed a pragmatic solution that works in practice from a regulatory, direct and indirect tax as well as legal perspective –in line with local Swiss and European regulations.
Call for action / Your benefits
We would be pleased to discuss further with you and offer a solution that is perfectly customized to your requirements and needs, in order to ensure a smooth, cost efficient and compliant sale of pharmaceutical products in the EU.
Download here the publication in PDF version: Pharma & Life Science Tax Hot topics
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