[Anonymous]

Reply To: Customs Valuation of Investigational Drug Product

Each company chooses to handle this a bit differently, but in recent experience with a very costly comparator we tried to use the local (import country specific) commercial value, rather than the material procurement and replacement value (25% premium), when declaring it for import/export. It was a bit tricky, as we wanted to ensure that we also had sufficient liability / replacement cost coverage for loss for insurance purposes, and as such we were not fully without risk in this area. This trial ran in 15 countries, including AsiaPac and LatAm, including several where import license applications were required upfront and value needed to be aligned with MOH expectations. We had, in prior trials, seen pushback when declaring lower values during that initial import license submission.