S.L. 458.47 Art. 6Investigator’s brochure.

(1) 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. This shall also apply to any update of the investigator’s brochure.

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

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