In preparation for and to support the work of the ETF during public health emergencies, the Agency shall:
(a)
develop and maintain IT tools, including an interoperable IT platform, for the submission of information and data, including electronic health data generated outside of clinical studies, that facilitate interoperability with other existing IT tools and with IT tools under development, and provide adequate support to national competent authorities;
(b)
coordinate independent monitoring studies on the use, effectiveness and safety of medicinal products intended to treat, prevent or diagnose diseases related to the public health emergency, using relevant data, including, where relevant, data held by public authorities;
(c)
as part of its regulatory tasks, make use of digital infrastructures or IT tools in order to facilitate rapid access to or analysis of available electronic health data generated outside of clinical studies and to facilitate the exchange of such data between Member States, the Agency and other Union bodies;
(d)
provide the ETF with access to external sources of electronic health data to which the Agency has access, including health data generated outside of clinical studies.
For the purposes of the first paragraph, point (b), coordination as regards vaccines shall be conducted in conjunction with the ECDC, in particular, through a new vaccine monitoring IT platform.