CRED SMPC 2024

17/09/2024

Informs prescribers and patients

What

• The primary purpose of the SmPC is to inform prescribers how to use the product safely and effectively ▪ Updated through the life of a product as new data emerge • Reference document for preparation of the Patient Information Leaflet • Important that the sections are clear, consistent and concise……

The Organisation for Professionals in Regulatory Affairs

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The SmPC sets boundaries for promotion and is key for market access and reimbursement

Why

ABPI Code of Practice for the Pharmaceutical Industry (2021):

Clause 11.2 “The promotion of a medicine must be in accordance with the terms of its marketing authorization and must not be inconsistent with the particulars listed in its summary of product characteristics……

EFPIA Code of Practice:

Section 1.02 “Promotion must be consistent with the particulars listed in the summary of product characteristics of the relevant Medicinal Product.”

Final labelling has to be commercially viable

● A medical need exists for the indication

● Different from and improves upon competitors

● Generates revenue to justify development

● Fits within corporate pipeline

The Organisation for Professionals in Regulatory Affairs

2021-abpi-code-of-practice.pdf (pmcpa.org.uk)

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