Auxiliary medicinal product

[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

[Meredith Lafond-Phesans]

Hello,
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!

[Rebecca Siegl]

Hello,
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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