A2. Authorisation from the sponsor if the submitting party is not the sponsor

If the submitting party is not the sponsor, an authorisation stating that the submitting party is authorised to submit the research file on behalf of the sponsor must be submitted.

Section 13d of the WMO also applies to research with medicinal products, which states that the party organising the research (the sponsor) or his/her legal representative must hold offices within the European Union. A legal representative is a natural person or legal person who is able to carry out tasks on behalf of the sponsor with regards to the research. The legal representative can be an organisation or investigator who is responsible for carrying out the study in the Netherlands on behalf of the sponsor. The tasks and responsibilities of the legal representative must be described in detail in a contract.