CRED SMPC 2024

17/09/2024

User Testing

2001/83/EC, Article 59(3):

Applies to new MAAs and where significant changes are made to the package leaflet: • First authorisation of a medicinal product with a new active substance • Medicinal products which have undergone change in legal status • Medicinal products with a new presentation • Medicinal products with a particular critical safety issue

‘The package leaflet shall reflect the results of consultations with target patient groups to ensure that is legible, clear and easy to use’

Justification would be required to demonstrate no User Testing is required e.g., extensions of same route of administration

The Organisation for Professionals in Regulatory Affairs

15

Packaging

Content and Layout

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18 sections

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Not all information present in the final printed carton needs to be present on the label text (e.g. blue-box, pricing etc) For multipack presentation there must be clear differentiation between outer carton (with blue-box) and inner carton (without blue-box)

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Pack design should not impact on readability

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Inclusion of Braille and Unique Identifier (2D barcode)

The Organisation for Professionals in Regulatory Affairs

16