Only authorised auxiliary medicinal products may be used in a clinical trial.

Paragraph 1 shall not apply where no authorised auxiliary medicinal product is available in the Union or where the sponsor cannot reasonably be expected to use an authorised auxiliary medicinal product. A justification to this effect shall be included in the protocol.

Member States shall ensure that unauthorised auxiliary medicinal products may enter their territories for the purpose of their use in a clinical trial in accordance with paragraph 2.