A Summary of Product Characteristics (SmPC) is an easy-to-access and product-specific resource enclosed with all the essential information about a product. The document includes the forms, clinical parameters, and pharmacological properties written and updated by organizations depending on their research and knowledge of a specific medicinal product. SmPCs, classified as short-form advertisements, are ratified and approved by the European Medicines Agency (EMA) or the Medicines and Healthcare Products Regulatory Agency (MHRA).
Abbreviated SmPC: An Underexplored Tool
An abbreviated SmPC is a consolidated version of the comprehensive SmPC that can be used as a reckoner for the reference of healthcare professionals. The document is enclosed with an important note/mandatory statement at the top of the document stating, “Before prescribing, consult/refer to the full prescribing information.” Pharmaceutical organizations must have a proper understanding of the role of SmPC and must be aware of the following to mitigate any errors while drafting them:
- Introducing SPC/SmPC
- Understanding Abbreviated SmPC
- Difference between SmPC and Abbreviated SmPC
- Drafting an Abbreviated SmPC
- Codes of Regulation
To simplify the understanding of an Abbreviated SmPC and its application in pharmaceutical marketing, Freyr brings in a free webinar on “Abbreviated SmPC: A New Take on Promotional Materials in the EU,” scheduled for October 28, 2022.
Register now and gain exclusive insights! Stay safe. Stay informed.
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