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)

We have adopted this International Scientific Guideline - CPMP/QWP/072/96, EMEA/CVMP/453/01

Last updated

17 January 2025

About this guideline

Overseas effective date: December 2001

Note: Can be read in conjunction with the Note for guidance on manufacture of the finished dosage form (CPMP/QWP/486/95)

Categories: Quality | Manufacturing

Quality | Stability

TGA Annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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