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Note for guidance on maximum shelf-life for sterile products for human use after first opening or following reconstitution

We have adopted this International Scientific Guideline - CPMP/QWP/159/96 corr. 

Last updated

Overseas effective date: July 1998

Categories: Quality | Stability

TGA annotations:

The allowance '.....unless reconstitution/dilution (etc) has taken place in controlled and validated aseptic conditions' detailed in the section: 'Unpreserved Sterile Products - Specific Text for Preparations for Infusion or Injection.' will only be permitted for products prepared in TGA licensed compounding facilities and in those hospital pharmacies that have been formally audited to the NCCTG standard and SHPA guidelines and have demonstrated that they can provide the appropriate level of sterility assurance.

  • 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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For more information see International scientific guidelines adopted in Australia.

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