Home Forums Where do I file…. ? Auxiliary medicinal product

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    • #4750
      Vanessa Tarraga

      Hi everybody,
      As an impact of the EU 536/2014 Regulation, we’re wondering where can be filed documentation related to Auxiliary medicinal product. This is not considered as IP so can’t be filed in section 6. Do we need a new zone? extend the zone 6 to non IP?
      Thanks for your answers

    • #4752

      we interpret Zone 06 to include any product administered as part of the study. This work in vaccines studies, but may be more complicated for drug studies?

      I hope others will chime in to help!

    • #4766
      Rebecca Siegl

      I would also classify it under Zone 06 and then under Non-IP Documentation. A Non-IP is per definition ‘a medicinal product which is not classed as an IMP in a trial, but may be taken by subjects during the trial.’ So in my opinion this section is the closest we can get to a suitable place for AxMP in the TMF.

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