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Adverse reactions reporting
Marketing authorisation holders should take appropriate measures to collect all reports of suspected adverse reactions associated with a medicinal product originating from spontaneous or literature reports, data collection systems, clinical trials/surveys as well as internet or digital media. For this purpose, a pharmacovigilance system should be implemented to allow the acquisition of sufficient information for the scientific evaluation of these reports.
- LITERO provides you with validation of all reports of suspected adverse reactions and submission to the competent authority (as ICSR or SUSAR) in a timely manner in accordance with the GVP Module VI via your established pharmacovigilance database.
- As the scientific literature is a significant source for detection of new suspected adverse reactions we will search once a week for relevant publications from a systematic literature review of widely used reference databases (e.g., Medline, Embase). In addition, we will monitor scientific and medical publications in local journals in countries where your medicinal products have a marketing authorisation. Reports of suspected adverse reactions from the scientific literature will be reviewed and assessed to identify and record ICSRs.