VI.App.2.1. When to start and stop searching in the medical literature

EU specific requirements as regards the monitoring of the medical literature are provided in VI.C.2.2.3.

In addition to the submission of serious and non-serious ICSRs or their presentation in periodic safety update reports, the marketing authorisation holder has an obligation to review the worldwide experience with medicinal product in the period between the submission of the marketing authorisation application and the granting of the marketing authorisation. The worldwide experience includes published medical literature. For the period between submission and granting of a marketing authorisation, literature searching should be conducted to identify published articles that provide information that could impact on the risk-benefit assessment of the product under evaluation. For the purpose of the preparation of periodic safety update reports (see GVP Module VII) and the notification of emerging safety issues (see VI.C.2.2.6. and GVP Module IX for guidance on emerging safety issue), the requirement for literature searching is not dependent on a product being marketed. Literature searches should be conducted for all products with a marketing authorisation, irrespective of commercial status. It would therefore be expected that literature searching would start on submission of a marketing authorisation application and continue while the authorisation is active.