Article 8

The information in the investigator’s brochure, referred to in Article 2(g) of Directive 2001/20/EC, shall be presented in a concise, simple, objective, balanced and non-promotional form that enables a clinician or potential investigator to understand it and make an unbiased risk-benefit assessment of the appropriateness of the proposed clinical trial.

The first subparagraph shall apply also to any update of the investigator’s brochure.

If the investigational medicinal product has a marketing authorisation, the Summary of Product Characteristics may be used instead of the investigator’s brochure.

The investigator’s brochure shall be validated and updated by the sponsor at least once a year.