Specific comments on text Line number(s) of Stakeholder number Comment and rationale; proposed changes Outcome the relevant text (To be completed by (If changes to the wording are suggested, they should be highlighted using 'track (To be (e.g. Lines the Agency) changes') completed by the Agency) 231 Comment: As with the new legislation reports from healthcare professionals and consumers are treated equally it should be added at the end of the paragraph that a healthcare professional’s causality assessment cannot overrule a consumer’s causality assessment. E.g. if there are two sources and a consumer states that the event is related and a healthcare professional states that the same event is unrelated, the overall causality is related. Addition of the following sentences is proposed: Proposed change (to add a sentence): In cases of two report sources - healthcare professional and consumer - the healthcare professional’s causality assessment cannot overrule the consumer’s causality assessment. If there are two different causality assessments (related and unrelated), causality for the event is related. 239-240 Comment: In the definition of off-label use and misuse it refers to use outside of the terms of the 242-243 marketing authorization – Clarification onwhich marketing authorization should be used for the determination of off-label use i.e. is it the MA in the country of origin of the report, or the EU MA would be beneficial. For simplicity EFPIA would hope that this is the MA in the country of the origin of the report . Proposed Change: “This relates to situations where the medicinal product is intentionally used for a medical purpose not in accordance with the terms of the marketing authorisation in that country.” 241 – 243 Comment: This definition is not harmonized with the one in the definition published in MedDRA® TERM SELECTION: POINTS TO CONSIDER - ICH-Endorsed Guide for MedDRA Users, Release 4.12, 1 September 2016, which defines misuse as the following: “Misuse For the purposes of term selection and analysis of MedDRA-coded data, misuse is the intentional use for a therapeutic purpose by a patient or consumer of a product – over-the-counter or prescription – other than as prescribed or not in accordance with the authorised product information.
Specific comments on text Line number(s) of the relevant text (e.g. Lines Stakeholder number (To be completed by the Agency) Comment and rationale; proposed changes (If changes to the wording are suggested, they should be highlighted using 'track changes') Outcome (To be completed by the Agency) 231 Comment: As with the new legislation reports from healthcare professionals and consumers are treated equally it should be added at the end of the paragraph that a healthcare professional’s causality assessment cannot overrule a consumer’s causality assessment. E.g. if there are two sources and a consumer states that the event is related and a healthcare professional states that the same event is unrelated, the overall causality is related. Addition of the following sentences is proposed: Proposed change (to add a sentence): In cases of two report sources - healthcare professional and consumer - the healthcare professional’s causality assessment cannot overrule the consumer’s causality assessment. If there are two different causality assessments (related and unrelated), causality for the event is related. 239-240 242-243 Comment: In the definition of off-label use and misuse it refers to use outside of the terms of the marketing authorization – Clarification onwhich marketing authorization should be used for the determination of off-label use i.e. is it the MA in the country of origin of the report, or the EU MA would be beneficial. For simplicity EFPIA would hope that this is the MA in the country of the origin of the report . Proposed Change: “This relates to situations where the medicinal product is intentionally used for a medical purpose not in accordance with the terms of the marketing authorisation in that country.” 241 – 243 Comment: This definition is not harmonized with the one in the definition published in MedDRA® TERM SELECTION: POINTS TO CONSIDER - ICH-Endorsed Guide for MedDRA Users, Release 4.12, 1 September 2016, which defines misuse as the following: “Misuse For the purposes of term selection and analysis of MedDRA-coded data, misuse is the intentional use for a therapeutic purpose by a patient or consumer of a product – over-the-counter or prescription – other than as prescribed or not in accordance with the authorised product information.
gvp_module_vi_adverse_reactions_rev_2_-_final_efpia_clean-1.docx