Common use of Other Sources Clause in Contracts

Other Sources. If MAHs become aware of a case report from non-medical sources, it should be handled as a spontaneous report. * Confidential treatment requested. Reports of overdose with no associated adverse outcome should not be reported as adverse reactions. They should be routinely followed up to ensure that information is as complete as possible with regard to symptoms, treatment, and outcome. The MAH should collect any available information related to its products on overdose, and report cases of these that lead to serious adverse reactions according to expedited reporting criteria. A parent-child/fetus exposure report (pregnancy exposure report) is any report where a fetus/breast-feeding infant/child is at risk of experiencing an adverse reaction/event as a result of being exposed to the product via mother and/or father. The periodic reports contained the records referred to in Article 104 of Council Directive 2001/83/EC and in Article 24(3) of Regulation (EC) No 726/2004 (Volume 9A), and similar reports required under Applicable Law in the United States. The PSUR is a practical and achievable mechanism for summarizing interval safety data, especially covering short periods (e.g., 6 months or 1 year), and for conducting an overall safety evaluation. 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. Examples of potential risks include: • Non-clinical safety concerns that have not been observed or resolved in clinical studies; • Adverse events observed in clinical trials or epidemiological studies for which the magnitude of the difference, compared with the comparator group (placebo or active substance, or unexposed group), on the parameter of interest raises a suspicion of, but is not large enough to suggest, a causal relationship; • A signal arising from a spontaneous adverse reaction reporting system; • An event which is known to be associated with other products of the same class or which could be expected to occur based on the properties of the medicinal product Any inquiry from a third party that questions the purity, identity, potency, or quality of any product(s).