Responsible Person Services.
Supporting sponsors with their EEA clinical trials needs.

What is a Responsible Person for EEA clinical trials?

The EudraVigilance registration process mandates the designation of a Responsible Person for EudraVigilance for every clinical trial carried out within the European Economic Area (EEA).

This requirement extends to sponsors who do not hold the status of a Marketing Authorization Holder (MAH) or Marketing Authorization Applicant (MAA), necessitating them to serve as their organization’s representative.

The European Medicines Agency (EMA) has established specific guidelines outlining the criteria for registration with EudraVigilance in the context of EEA-based trials.

The specific registration criteria are contingent upon whether a trial sponsor is already established within the EEA, holds the designation of MAH or MAA, or lacks any current established presence or process within the EEA.

What are the EMA registration guideline criteria?

The following information is taken directly from the EMA guidelines.

What type of organisations should register with EudraVigilance?

All marketing-authorisation holders (MAHs), applicants for a marketing authorisation in the EEA and sponsors of clinical trials conducted within the Community should register with EudraVigilance.

Which person from a marketing-authorisation holder or applicant for a marketing authorisation in the European Economic Area (EEA) organisation should register?

For a marketing-authorisation holder or applicant for a marketing authorisation in the EEA, the QPPV of the organisation’s headquarter in the EEA is the organisation’s representative who should register with EudraVigilance. That qualified person shall reside in the Community.

Which person from a sponsor of a clinical trial conducted in the EEA, where the sponsor is also an MAH or an applicant for a marketing authorisation in the EEA should register?

For a sponsor, who is also an MAH or an applicant in the EEA, the QPPV of the organisation’s headquarter in the EEA continues to be the organisation’s representative in the EudraVigilance registration process. No additional registration of a responsible person for EudraVigilance is required.

Which person from a sponsor of a clinical trial conducted in the EEA other than a MAH or an applicant for a marketing authorisation in the EEA should register?

For a sponsor, who is not a MAH or an applicant, an organisation’s representative for the EudraVigilance registration process (Responsible Person for EudraVigilance) should be appointed. Only one Responsible Person for EudraVigilance should be appointed by the sponsor for all clinical trials conducted by the sponsor in the EEA.

This Responsible Person for EudraVigilance should be appointed by the sponsor’s named person – a contact person mentioned in section B.1.2 of the request for authorisation, submitted to the relevant competent authority of a member state, to conduct a clinical trial in at least one centre located in the EEA (hereafter referred to as ‘Named Person’).

Which person from a sponsor of clinical trials conducted in the EEA, not established in the EEA, should register?

If a sponsor is conducting a clinical trial in the EEA but is not established in the EEA, a legal representative of the sponsor has to be established in the EEA. The notion of legal representative refers back to existing national laws and may include natural or legal persons, an authority and/or body provided for by national law. As a general principle, only one legal representative can act on behalf of one sponsor in one clinical trial.

How Aeigisana’s Responsible Person Services can support clinical trial sponsors.

Full service options.

We can provide you with an experienced standalone Responsible Person allocated to individual projects or across your development program for all your clinical trials conducted in the EEA, and we can fully support all of your Eudravigilance registration and administration requirements.

Dedicated to your needs.

Our Clinical Safety team are committed to ensuring the compliance, efficiency and success of your trial. Whatever your Responsible Person requirements, we can support you.