Identified risk: “An untoward occurrence for which there is sufficient evidence of an association with the medicinal product of interest” * Potential risk: “An untoward occurrence for which there is some basis for suspicion of an association with the medicinal product of interest but where this association has not been confirmed” * Missing information: “Gaps in knowledge about the safety for a medicinal product for certain anticipated utilisations or for use in a particular patient population, which could be clinically significant” *, ** Important risk: “An identified risk or potential risk that could have an impact on the risk-benefit balance of the product or have implications for public health” *, ** *GVP Module V **GVP Module V Revision 2