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

This guideline applies to human and veterinary medicines.

Current effective version

PDF icon<b>Adopted guideline</b>

Reference number



Published 31/05/2001
Effective from 01/12/2001
Keywords Shelf-life, stability, finished dosage form
Description This 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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