CRED SMPC 2024

17/09/2024

The Future: Digital Implementation = ePIL

⚫ PIL available in a digital format replacing or alongside the paper version.

⚫ Some Health Authorities are moving to ePIL, particularly for HCP administered products – fast changing environment: o Live: – Australia, New Zealand, Egypt, Japan, Malaysia, Singapore, Taiwan. o Pilots in progress: – EU (EMA), Baltics (Latvia/Lithuania/Estonia), Belgium and Luxembourg, Germany, Iceland, India, Spain, Germany, Brazil, Chile, UAE. o Emerging initiatives: – Canada, China, South Africa, Indonesia, United Kingdom, USA.

(Source: UK ePI Task Force evidence review: electronic patient information leaflets (ePILs) – August 2024)

BENEFITS – quicker access to latest approved information (particularly safety), support of self-selection for OTC products, environmental impact.

The Organisation for Professionals in Regulatory Affairs

CHALLENGES – technology, managing both digital and print implementations.

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ePIL Implementation – What Does Industry Need to Do?

⚫ Assess impact on pack

⚫ QC checks will likely remain, e.g. QC of published ePIL against HA approved PI

⚫ Recordkeeping to document implementation:

o Publication date of the new version of the ePIL

o First batch with new printed PIL/last batch with old printed PIL (if both in place).

⚫ Embrace change from Labelling Operations to Digital Operations

The Organisation for Professionals in Regulatory Affairs

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