Common use of Off Label Use Clause in Contracts

Off Label Use. Situations where a medicinal product is intentionally used for a medical purpose not in accordance with the authorized product information. Administration of a quantity of a medicinal product given per administration or cumulatively which is above the maximum recommended dose according to the authorized product information. Communication that contains any allegation, written, electronic or oral, expressing concern with the quality of a product that could be related to good manufacturing practice or good distribution practice. Periodic review of all sources of safety data to be sure that no potential PV case is missing. Source of data included at least quality complaint, medical inquiries and literature search. Periodic review between both parts of all pharmacovigilance cases exchanged. The risk management plan established by the marketing authorisation holder shall contain the following elements: (a) an identification or characterisation of the safety profile of the medicinal product(s) concerned; (b) an indication of how to characterise further the safety profile of the medicinal product(s) concerned; (c) a documentation of measures to prevent or minimise the risks associated with the medicinal product, including an assessment of the effectiveness of those interventions; (d) a documentation of post-authorisation obligations that have been imposed as a condition of the marketing authorization. A set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions. Note: The term "life-threatening" refers to a reaction in which the patient was at risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if more severe. Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; or development of drug dependency or drug abuse. Any suspected transmission via a medicinal product of an infectious agent is also considered a serious adverse reaction. All cases linked to an AE/ADR to drugs or dietary supplements, special situation, medical device incident. Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action.

Off Label Use. Situations where a medicinal product is intentionally used for a medical purpose not in accordance with the authorized product information. Administration of a quantity of a medicinal product given per administration or cumulatively which is above the maximum recommended dose according to the authorized product information. Communication that contains any allegation, written, electronic or oral, expressing concern with the quality of a product that could be related to good manufacturing practice or good distribution practice. Periodic review of all sources of safety data to be sure that no potential PV case is missing. Source of data included at least quality complaint, medical inquiries and literature search. Periodic review between both parts of all pharmacovigilance cases safety reports exchanged. The risk management plan established by the marketing authorisation holder shall contain the following elements: (a) an identification or characterisation of the safety profile of the medicinal product(s) concerned; (b) an indication of how to characterise further the safety profile of the medicinal product(s) concerned; (c) a documentation of measures to prevent or minimise the risks associated with the medicinal product, including an assessment of the effectiveness of those interventions; (d) a documentation of post-authorisation obligations that have been imposed as a condition of the marketing authorization. A set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions. - Results in death, - Is life-threatening, Note: The term "life-threatening" refers to a reaction in which the patient was at risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if more severe. - Requires inpatient hospitalisation or prolongation of existing hospitalisation, - Results in persistent or significant disability/incapacity, - Is a congenital anomaly/birth defect, - Is an important medical event (an event that jeopardizes the patient or may require intervention to prevent one of the other outcomes listed above) Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; or development of drug dependency or drug abuse. Any suspected transmission via a medicinal product of an infectious agent is also considered a serious adverse reaction. All cases linked to an AE/ADR to drugs or dietary supplements, special situation, medical device incident. Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action.