CRED SMPC 2024

17/09/2024

Guideline wording - Excipients

EXCIPIENTS IN THE LABEL AND PACKAGE LEAFLET OF MEDICINAL PRODUCTS FOR HUMAN USE

Please Note: Guidance are not always aligned- the below is the excipient guidelines BUT the QRD guideline decision on use of terms state Medical product to be used in the SmPC. In the PL, “medicine” is to be used.

Example – lactose as an excipient (Oral formulations)

SmPC wording: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Package insert wording:

Threshold zero: If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product Threshold 5g: Contains x g lactose (x/2 g glucose and x/2 g galactose) per dose. This should be taken into account in patients with diabetes mellitus

https://www.ema.europa.eu/en/annex-european-commission-guideline-excipients-labelling-package-leaflet medicinal-products-human#current-effective-version-section

The Organisation for Professionals in Regulatory Affairs

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/compilation-quality-review-documents decisions-use-terms_en.pdf

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Guideline wording - Excipients

EXCIPIENTS IN THE LABEL AND PACKAGE LEAFLET OF MEDICINAL PRODUCTS FOR HUMAN USE

Sodium as an excipient- Multiple options depending on the amount and formulation.

Example sodium – (Oral formulations)- less than 1mmol*

Package insert wording:

This medicine contains less than 1 mmol sodium (23 mg) per, that is to say essentially ‘sodium free’

AND as per the Compilation of QRD decisions on stylistic matters in product information

Statement is also needed in SmPC 4.4

..the sodium/potassium-free statement provided in the annex to the Excipients Guideline should always be included at the end of the section.

* Other guidance applies to other quantities

https://www.ema.europa.eu/en/annex-european-commission-guideline-excipients-labelling package-leaflet-medicinal-products-human#current-effective-version-section

The Organisation for Professionals in Regulatory Affairs

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