CRED SMPC 2024

17/09/2024

Learning Objectives

To understand critical time points in the drug development timeline to consider for Label and Leaflet implementation. To recognize practical issues that may be encountered when implementing new or revised labels and leaflets. To apply this learning to the role of regulatory affairs in the context of other internal and external stakeholders.

The Organisation for Professionals in Regulatory Affairs

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“Artwork” vs “Labelling”

⚫ Label/labelling is a term with both general and specific meanings:

o Generally refers to the whole of the Product Information (SmPC/labelling/PIL) i.e. the ‘product label’.

o Specifically refers to the content of the Product Information which will appear on the primary or secondary packaging (SmPC/ labelling/PIL ).

⚫ Artwork is an electronic file containing all the information used to create the physical packaging component utilised in product manufacture:

o The regulated content from the Product Information,

o Market- specific “blue - box” information,

o Technical elements such as dimensions, colour, materials info, coding, security features, braille, serialisation information, anti-counterfeit measures, etc.

⚫ Implementation of Labelling requires creation of Artwork (except ePIL) .

The Organisation for Professionals in Regulatory Affairs

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