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 composition in terms of the active substance(s) and excipients, know
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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