UncategorizedWhat are the requirements for the legal representative of a non EU-sponsor in view of article 74 of

7 ינואר 20210

New draft of the guidance documents applying to clinical trials has been issued in July 2020 by EU.

If the sponsor is not established in the EU a legal representative of the sponsor has to be established in the EU

If the sponsor is the same for several different trials, it is acceptable (but not obligatory) to have one central legal representative in EU for all non-EU sponsored trials, as long as the responsibilities provided for by the regulation can be effectively performed

It is also acceptable to use an established company as a legal representative.

The applicant for the application to the Member State (competent authority and the Ethics Committee) might be different from the legal representative.

According to article 74(1) of the Clinical Trials Regulation the legal representative shall ensure compliance with the sponsor’s obligations pursuant to the Regulation. This implies that the legal representative has the same responsibilities and liabilities as the sponsor and should act on behalf of the sponsor based on a contractual agreement. It also implies that the Member States may address the legal representative with any request related to the conduct of a clinical trial.

In order to enable the legal representative to ensure compliance with the sponsor’s obligations under the Clinical Trials Regulation it is recommended that

the contract obliges the sponsor to provide the legal representative with all necessary information and the legal representative to immediately notify the sponsor in case (s)he becomes aware of any incompliance with the Regulation.

Member States may choose not to require the establishment of a legal representative, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that clinical trial

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