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
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.