CRED SMPC 2024

17/09/2024

Outer Packaging

Multipacks

• The multipack outer carton should display all legally required items (including blue box) with inner cartons stating - components of a multipack, can’t be sold separately

• Each individual inner cartons must contain a package leaflet

• Braille is expected to be present in both outer packaging and inner cartons

• The contents of the multipack are expressed as:

- On the outer carton or label: “Multipack: 180 (2 packs of 90) film-coated tablets

- On the inner carton: “90 film - coated tablets”

• The MAH may consider not including all the requirements of the outer packaging on the inner cartons in order to comply with all the requirements and ensure that the packs cannot be sold separately

The Organisation for Professionals in Regulatory Affairs

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Outer Packaging

Multilingual packs

• ‘Multilingual packaging’ - use of two or more languages for at least one component of the packaging material for a medicinal product

• Directive 2001/83/EC, Article 63 permits the use of multilingual text, provided that the same information appears in all the languages used (except for ‘blue - box’ information)

Key aspects for consideration

• Must have the same invented name and strength, harmonised product information and the same legal status

• Information in each language should be blocked together where possible

• ‘Blue - box’ requirements for all countries should be listed

• The readability of the resulting package must not be significantly compromised when two or more languages are added to the pack

The Organisation for Professionals in Regulatory Affairs

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