Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.5

Document information
Reference	EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)
Validity area	EU
Scope(s)	NIS
Document name	GVP: Module VIII EMA/813938/2011
Version / Revision	Rev. 3 (2017)
Status	Current
Document type	Official guideline
Language(s)	EN
Description	Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies (Rev 3)
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Scope	NIS
Document part	VIII.B.5
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Publication of study results for investigator-initiated studies (PASS)

Content

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.