The scope of this guidance document relates to phase 1 of Policy 0070 which excludes individual patient data (IPD). Article 17 of Regulation (EU) No 123/2022 provides for the publication of the clinical data submitted to the Agency in support of the application in a public health emergency, such as the Covid-19 pandemic.
Clinical reports will be published, under Policy 0070, following conclusion of the regulatory decisionmaking process (positive, negative European Commission Decision or withdrawn of the Marketing Authorisation Application) in the frame of centralised marketing authorisation procedures, as follows:
• as part of a marketing authorisation application (MAA) with the exception of informed consent applications; effective date 1 January 2015, or
• as part of a procedure under Article 58 of Regulation (EC) No 726/2004; effective date 1 January 2015, or
• submitted by a third party in the context of a MAA: effective date 1 January 2015…
