Start of shelf-life of the finished dosage form (Annex to the note for guidance on the manufacture of the finished dosage form)

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This guideline applies to human and veterinary medicines.

Current effective version

Adopted guideline

Reference number

CPMP/QWP/072/96

EMEA/CVMP/453/01

Published31/05/2001
Effective from01/12/2001
KeywordsShelf-life, stability, finished dosage form
DescriptionThis document assists with establishing the expiration period of a production bath of a medicinal product. It is not applicable to biological medicinal products such as vaccines, sera, toxins and allergens, products derived from human blood and plasma, as well as medicinal products prepared biotechnologically.


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