Spring Intro 2023
Content
Must reflect the SPC: • All relevant information for the patient must be included in simple terms
Order of the information is fixed: • Templates may help to ensure the information is placed accurately within the PIL
Use accessible language: • Avoid jargon • Active rather than passive • Provide explanations • Risk expression
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Additional concepts to improve risk communication in PILs
Headlines • To improve access to key information
Guidance on the description of risk/safety advice • Order, format, words, and numbers
Risk in the context of Benefit • To provide overall balance
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