CRED SMPC 2024

Readability guideline

• Primary objective is to provide guidance on how to ensure that the information on the labelling and package leaflet is accessible to and can be understood by those who receive it, so that they can use their medicine safely (published January 2009)

• Can be accessed at: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol2/c/2009_01_12_readability_guideline_final.pdf

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MHRA Guidance Documents

• Best Practice Guidance on the Patient Information Leaflets 2012 (includes information on provisions for blind and partially sighted patients and information permitted under Article 62)

• Best Practice Guidance on the Labelling and Packaging of Medicines

• Guidance on warnings statements to be applied to packaging:

https://www.gov.uk/government/publications/best-practice-in-the-labelling-and-packaging-of-medicines

https://www.gov.uk/government/publications/best-practice-guidance-on-patient-information-leaflets

https://www.gov.uk/government/publications/warning-statements-for-labels-and-leaflets-of-certain medicines

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