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ISO 20069:2019 provides guidance for assessment and evaluation of planned changes to drug delivery systems that are integral with, packaged with, or cross-labelled for use with a specified medicinal product. This document is applicable to the drug delivery system's lifecycle from registration clinical studies to end-of-life. This document is applicable to the assessment of changes within the following drug delivery systems:
  • needle-based injection systems for medical use;
  • aerosol drug delivery devices;
  • needle-free injectors for medical use.