S.L. 458.43 Art. 19General provisions.

(1) These regulations are without prejudice to the civil and criminal liability of the sponsor or investigator. To this end, the sponsor or a legal representative of the sponsor must be established in the Community.

(2) Unless the Licensing Authority has established precise conditions for exceptional circumstances, investigational medicinal products and, or the devices used for their administration shall be made available free of charge by the sponsor to the trial subjects.