Cromos Pharma’s Guide to the EU Legal Representation Requirements

Questions answered in this article:

• Why do I need a Legal Representative for clinical trials in the European Union (EU)?
• What services does a Legal Representative provide?
• What is the logistics of Legal Representation?
• What are the responsibilities of a Legal Representative?
• What makes Cromos Pharma ideally equipped to represent your interests in Europe? 

The Need for EU Legal Representation in Clinical Trials

Any biopharmaceutical company that plans to conduct clinical trials in the EU and doesn’t have a registered office in the European Economic Area (EEA), needs to use the services of a Legal Representative. This provision, first established in 2001, aims to ensure that the EU offers an attractive and favorable atmosphere for carrying out clinical research on a large scale, with high public transparency and safety standards for the clinical trial participants. If you are a Sponsor who is interested in conducting clinical trials in the EU then, according to the EU Clinical Trials Regulation No 536/2014 (CTR), you need to appoint a Legal Representative with an established office in the EEA.

In case trial-related legal proceedings are initiated within the EU/EEA, a Legal Representative acts as the agent of a Sponsor. It is important to note that a Legal Representative does not accept any of the legal rights and responsibilities of the Sponsor. Its role is to act as a liaison between the Sponsor and the competent EU entities and to perform the activities that are specified in the Letter of Authorization.

The Main Services Provided by the Legal Representative

• To help the Sponsor understand the EU legal requirements.
• To maintain direct contact with the regulatory authorities. 
• To be accountable for patient safety, to investigate fraud, or other non-compliance matters that are under the jurisdiction of the EU courts.

The Logistics of Legal Representation

• The Sponsor may select only one Legal Representative for a specified trial.
• The Legal Representative can be located in any EU member state, regardless of the member state(s) in which the trial will be conducted.
• A Letter of Authorization must be initiated on the Sponsor’s letterhead, which includes a declaration by the Legal Representative for the assumed role.
• A Letter of Authorization must be included in the initial submission dossier to a Competent Authority or Ethics Committee.
• The Sponsor may appoint different Legal Representatives for different trials.

Responsibilities of the Legal Representative

• To assist the Sponsor in understanding the EU regulatory provisions.
• To devise a tailored solution that ensures compliance with EU regulations.
• To stay up to date on newly issued legal regulations and to communicate them to the Sponsor in a timely manner.
• To assist in coordinating site inspections that assure compliance with the International Conference of Harmonization (ICH) and Good Clinical Practice (GCP).

Cromos Pharma’s Advantage

A clinical gateway to Europe

With an established network of offices in the EU and in the European Economic Area (EEA), Cromos Pharma offers access to the EU clinical trials marketplace by providing both clinical development and Legal Representation services.

A team that represents your interests 

When it comes to addressing the most complex matters with the regulatory authorities, member state governments and professional bodies with oversight or jurisdiction over EU clinical trials, Cromos Pharma’s Legal Representative team has all the qualifications that guarantee the highest level of competence. Our goal is to make sure that your clinical trial journey is planned and executed in the most efficient and compliant manner.

What competence does Cromos Pharma have to provide LR services?

Operating from our EU headquarters in Dublin, Ireland since 2014, Cromos Pharma has been acting as an EU Legal Representative supporting EU-based clinical trials. We have in-depth knowledge of the regulatory and legal frameworks of the EU member states and the EEA local and national requirements. By carefully analyzing both the EU/EEA and national landscapes and requirements, we can instruct you on the most fitting European member state for your trial registration and its subsequent conduct. Cromos Pharma has all the tools to help the Sponsor navigate the complexity of EU regulations and requirements, while keeping close communication with the European Authorities, and helping find the most optimal resolutions that satisfy your specific needs. 

What to expect upon signing of a Legal Representation Agreement with Cromos Pharma?

By choosing Cromos Pharma as your EU Legal Representative, you should expect the following:

• Significant financial and time savings from foregoing the company registration procedures and establishing a physical office in the EU.
• Access to a dedicated partner who fully represents your interest in the EU jurisdictions.
• Comprehensive and ad hoc consultations regarding the ever-changing landscape of the EU clinical trial regulations.

Cromos Pharma has nearly two decades of experience managing all aspects of clinical trials across multiple therapeutic areas and many regulatory jurisdictions. With operations in the US, Central and Eastern Europe, Central Asia and Turkiye, we combine our global expertise with in-depth local knowledge to deliver end-to-end solutions for our pharma and biotech clients.

If you have any questions or want to find out more about how Cromos Pharma can support your next clinical program please get in touch with us by emailing inquiry@cromospharma.com.