definiens: means, subject to any amendment pursuant to the ICH from time to time, any unsolicited communication to a party, Regulatory Au thority or other person that describes an Adverse Event or an Adverse Drug Reaction in a patient admi nistered the Product, whether alone or together wit h one or more other medicinal products, and which doe s not derive from a study or any organized data collection scheme . Spontaneous reports include repo rts from health care professionals ( medically confirmed reports ) and non - health care professional s or consumers ( medically unconfirmed reports ) . All spontaneous reports received from consumers or heal th care professionals are considered as suspected Adverse Drug Reactions . Cases originating from the internet where the website is under the Marketing Authorization Holder ’s management or responsibility should be screened for potential adverse reactions by the appropriate Party . Other types of spontaneous r eports with or without associated adverse events including overdose, medication errors and lack of e fficacy reports should be exchanged, due to periodi c reporting requirements . Other types of reports that qualify for expedited reporting include solicited reports generated by marketing programs or other methods us ed to encourage contact between the consumers and either Napo or [COMPANY], where the information has bee n obtained additionally to the main purpose of the program, and would most likely not have been the su bject of voluntary reporting to a health care professional or the company . Prospective and retros pective exposure in utero or during breastfeeding spontaneous reports are collected and followed up t o obtain outcome information