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

This guideline applies to human and veterinary medicines.

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.

Keywords: Shelf-life, stability, finished dosage form

Current effective version

Note for guidance on start of shelf-life of the finished dosage form (annex to note for guidance on the manufacture of the finished dosage form)

AdoptedReference Number: CPMP/QWP/072/96Legal effective date: 01/12/2001