We would like to share a very important news that you might anticipate. This time, not an indirect tax one but more a regulatory one.
This news will impact all the companies that are doing clinical trials in Europe.
In a nutshell :
Researchers and companies wishing to carry out a clinical trial for medicines for human use in the European Union (EU) and European Economic Area (EEA), need to submit information on the investigational medicine involved to the European Medicines Agency (EMA). This requirement is based on EU pharmaceutical legislation, as outlined in the European Commission Communication
EU pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. It aims to ensure the EU offers an attractive and favorable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants.
The Clinical Trials Information System (CTIS) supports the flow of information between clinical trial sponsors, EU Member States, European Economic Area (EEA) countries and the European Commission. CTIS went live with a searchable public website on 31 January 2022.
It supports interactions between clinical trial sponsors (researchers or companies that run a clinical trial and collect and analyze the data) and regulatory authorities in the EU Member States and EEA countries, throughout the lifecycle of a clinical trial.
As a summary and potential next steps / thoughts
- Identify whether you will be impacted by this new regulation and to deal with the new CTIS;
- Be aware that the absence of CTIS compliance might impact your business due to the fact the your client, organisation, etc may not be able to accept your product;
- This CTIS (assumption today) might increase the possibility to highlight, select foreign companies and then investigate the customs considerations;
- As the value is the basis for customs (duties) and/or VAT, how the customs / proforma value is calculated and do we have any information in order to sustain such value ?
- Do I have a single or multiple entry points in EU ? for example from Switzerland in Europe through Italy, Netherland, Germany, etc ? What would be the considerations of having multiples entry points ?
As the deadline and the end are approaching, It might be interesting to double check whether you should consider this new regulation and how to manage it. Subsequently, to contact and approach your partners in EU in order to determine what they need to obtain in connection with this new regulation.
Happy to discuss in more detail with you personally
Dr. Sandra Ragaz, Partner
Leader Pharma & Life Science VAT Switzerland
+41 79 792 72 98
Olivier Comment, Director
+41 79 693 98 74