- For clinical trials in the EU, UK and Switzerland
- Gain marketing authorisation
- Obtain SME status at the EMA
Every sponsor conducting a clinical trial in the European Union without a registered office within the territory of the European Economic Area (EEA) is required to work with a legal representative located in one of the EEA countries, according to the EU Clinical Trial Regulation and the former EU Clinical Trial Directive. This requirement applies to all clinical trials conducted to evaluate medicinal and/or pharmaceutical products as well as medical devices.
Your EU legal representative for clinical trials
Legal representation in EU
A legal representative acts as the agent of a sponsor in the event that legal proceedings are initiated and instituted within the EU/EEA. Every clinical trial requires a legal representative.
Legal representation in Switzerland
For clinical trials conducted in Switzerland, according to Article 2 (c) of the “Ordinance on clinical trials with therapeutic products” a sponsor not established in Switzerland has to assign a representative based in Switzerland.
Legal representation to obtain SME Status
We act as your legal representative to obtain the official recognition as a small and mid-sized Enterprise (SME) at the European Medicines Agency (EMA). Lumis has been granted the SME status by the EMA.
Your clinical gateway to Europe
As your EU legal representative in Europe and Switzerland, we act on your behalf in the event that legal proceedings are initiated and instituted within the EU/EEA and ensure that you comply with the EU Clinical trials Regulation 536/2014 and the former EU Clinical Trial Directive (2001/20/EC) and the Suisse Ordinance. Non-European companies need a legal representative when applying for the SME status at the European Medicines Agency EMA.
What we can do for you
- Gain access into the European market
- SME status to benefit from administrative, regulatory and financial support by the EMA
- Fully represent your interests
- Save costs through avoiding expensive implementation of your own subsidiaries
Not sure what a specific regulation says or want to know more about the meaning behind a certain term? Visit our glossary.
Our expertise, your benefit
The Lumis International experts have profound knowledge of the legal and national requirements in the EU-market. We represent biopharmaceutical, biosimilar and medical device companies around the globe since 2013.
