Spring Intro 2023

Summary of Product Characteristics (SmPC) - legislation

• Requirement that in order to obtain a marketing authorisation, a Summary of Product Characteristics in accordance with Schedule 8 of the Human Medicines Regulations (or Article 11 of Directive 2001/83/EC, as amended) must be included in the application

• It is a description of a medicinal product’s properties and the conditions attached to its use (explains how to use and prescribe the medicine)

• The content cannot be changed without approval of the originating competent authority

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Summary of Product Characteristics (SmPC) – relationship with leaflet

• Content of the SmPC must be reflected in the patient information leaflet (PIL)

• The SmPC in its entirety may be used as the leaflet intended for the healthcare professional (technical leaflet)

• It is the licence holders responsibility to ensure that the SmPC is updated in line with current medical knowledge and safety information whenever this changes

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