Table 2.

Obligation of marketing authorization holders to report information on suspected adverse reactions from the internet or digital media

Marketing authorization holders should regularly screen internet or digital media [see Definitions] under their management or responsibility, for potential reports of suspected adverse reactions. In this aspect, digital media is considered to be company sponsored if it is owned, paid for and/or controlled by the marketing authorization holder [see Definitions]. The frequency of the screening should allow for potential valid ICSRs to be reported to the competent authorities within the appropriate reporting timeframe based on the date the information was posted on the internet site/digital medium. Marketing authorization holders may also consider utilizing their websites to facilitate the collection of reports of suspected adverse reactions.