VIII.B.5. Publication of study results

For studies that are fully or partially conducted by investigators who are not employees of the marketing authorisation holder, the marketing authorisation holder and the investigator should agree in advance on a publication policy allowing the principal investigator to independently prepare publications based on the study results irrespective of data ownership. The marketing authorisation holder should be entitled to view the results and interpretations included in the manuscript and provide comments prior to submission of the manuscript for publication.

VIII.B.5.1. Submission of manuscripts accepted for publication

In order to allow competent authorities to review in advance the results and interpretations to be published, the marketing authorisation holder initiating, managing or financing a non-interventional PASS should communicate to the Agency and the competent authorities of the Member States in which the product is authorised the final manuscript of the article within two weeks after first acceptance for publication.