Spring Intro 2023

16/02/2023

Educational Tools (EdTs)

• High-level content of EN EdTs approved by PRAC • Key Elements are in RMP Annex VI and Labelling Annex IID

PRAC

•Agreed EN EdTs translated into EEA languages

MAH

•NCAs approve local EdTs – may request changes

NCA

• Locally approved EdTs distributed. Monitor who EdTs are sent to (# of HCPs) & format (paper/electronic)

Local

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Direct Healthcare Professional Communication (DHPC)

● Issued under certain scenarios (e.g. sig. change to risk-benefit balance) ● Communicates important safety information on a medicine; – Specific actions – Change to current practice ● Agreed between Heath Authority & MAH: – Contents of DHPC – Communication plan, including intended recipients + dissemination timetable

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