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guideline is for use by competent authorities, applicants for a marketing authorisation and marketing authorisation holders. its annex provides a list of excipients which should be stated on the label and outlines the information for those which must appear on the package leaflet. this guideline does not
in general, excipients are defined as any constituents of a medicinal product, other than the active substance and the packaging material. according to annex i of directive / /ec, such constituents may include: • colouring matter, preservatives, adjuvants, stabilisers, thickeners, emulsifiers, flavouring...
https://ec.europa.eu/health/sites/health/files/files/legal/2017_pc_guidelines_excipient/pc_2017_legal_consultation_document.pdf