Summary of Product Characteristics (SPC/SmPC): Introduction, Overview and relevance in aggregate reports

For whom is this article relevant and intended?

What is SmPC and why it is so critical?

How is the information included in the SmPC prepared by the MAH?

Why is the SmPC an essential source of information on a medicine?

SmPC remains the cornerstone between assessment and information

SmPC and it’s sections/ contents:

High-level overview of various key SPC sections and its contents

Safety sections of SPC and most important points you should know

· Sections 4.3 (contraindications), Section 4.4 (Warnings and precautions), Section 4.5 (Drug interactions), Sections 4.6 (Pregnancy, fertility and breast-feeding), Section 4.7 (Effects on ability to drive and handle machines) and Section 4.8 (Safety profile of the medicine and list all adverse reactions) are considered the safety sections of SPC.

Situations leading to a warning or precaution (section 4.4 of SmPC) :

All events in section 4.8 of the RSI are by default ‘identified’ (since we have cases known- a prerequisite for inclusion in 4.8 to begin with) but not all of them are important! All events discussed in section 4.4 of the RSI are by default ‘important’ but not all of them are identified (as cases may or may not be reported)!

Some important points regarding section 4.8 Undesirable effects in SmPC

Section 4.4/4.5/4.6 + Section 4.8= Important identified risk

Just section 4.4/ 4.5/ 4.6 or if mentioned as a drug class effect and NOT in 4.8= Important potential risk

RSI is the single most important key routine risk minimization tool!

If the MAH does not have a CCDS, then the MAH should use the most comprehensive local prescribing text.

Practical concerns for MAHs:

Options for RSI selection:

Company core data sheet (CCDS):

The CCDS includes:

The core safety information contained within the CCDS is referred to as the CCSI.

Remember: Inclusion in section 4.8 is the highest level of PVG accomplishment!

Interesting: Lifecycle of an event in PVG:

· When regulators or MAH become aware of potential association of an event with a drug → Event under monitoring in section 15 of PBRER → Signal → Risk (safety concern) → Variation → Inclusion in the PI/SmPC in an appropriate section.

Important points to remember for SPC (revision)



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