Transcription of Section 2: Qualitative and quantitative composition
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Section 2: Qualitative and quantitative composition
An agency of the European Union SmPC Advisory Group Section 2: Qualitative and quantitative composition Rev. 1 SmPC training presentation Note: for full information refer to the European Commission s Guideline on summary of product characteristics (SmPC) Index objectives principles Qualitative declaration quantitative declaration information Biological medicinal products Herbal medicinal products * Section 2: Qualitative and quantitative composition 2 I. General objectives of Section 2 Section 2: Qualitative and quantitative composition 3 Excipients listed in the Annex to the Guideline on the excipients in the label and package leaflet of medicinal product for human use should be stated here under a separate subheading qualitatively, and, quantitatively This Section should provide full details of the Qualitative and quantitative
I. General objectives of section 2 3 Section 2: Qualitative and quantitative composition Excipients listed in the Annex to the “Guideline on the excipients in the label and package leaflet of medicinal product for human use”
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