Excipients Guideline

Last updated on: 17.12.2024

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DefinitionThis section has been translated automatically.

With the supplementary delivery 2023/1, the additional labeling according to the "Excipients Guideline" or the BfArM special features list was implemented in the NRF regulations NRF 11.83., NRF 11.126. and NRF 22.16., among others. If ethanol is contained as an excipient or active substance, information on the quantity or content of alcohol must be provided on the medicinal product for oral or parenteral use as well as for inhalation or application to the skin.

Last updated on: 17.12.2024