Based on the legislatively defined set of some of the above specified "basis for change" documents, changes in the definition of a Marketed Substance - Production Chain initiate following variations that have to be reported to the competent Health Authorities:

• B.I.d.1 Change in the retest period/storage period or storage conditions of the active substance where no Ph. Eur. Certificate of Suitability covering the retest period is part of the approved dossier

  • a) 1. Reduction of the retest period

  • a) 2. Extension of the retest period based on extrapolation of stability data not in accordance with ICH/VICH guidelines
  • a) 3. Extension of storage period of a biological/immunological active substance not in accordance with an approved stability protocol
  • a) 4. Extension or introduction of a retest period/storage period supported by real time data
  • b) 1. Change to more restrictive storage conditions of the active substance
  • b) 2. Change in storage conditions of biological/immunological active substances, when the stability studies have not been performed in accordance with a currently approved stability protocol
  • b) 3. Change in storage conditions of the active substance

  • c) Change to an approved stability protocol