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Guideline

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Note for Guidance on Start of Shelf-Life of the Finished Dosage Form
Short Title:CPMP/QWP/072/96
Internet:http://www.ema.europa.eu/pdfs/human/qwp/007296en.pdf
Origin/Publisher:EMEA
Content:This guideline defines that the date of release of a batch should be used for the calculation of the expiration period. If batches are released exceeding 30 days from the date of production - which is defined in this guideline - the date of production should be taken as the start of the shelf-life.
Document Type:CPMP Note for Guidance