I’m seeking some tips/strategy suggestions for managing IP with short expiry dating in LATAM countries. This would be a new product formulation and I think we’ll likely only have data supporting a 6 month shelf life – best case scenario is probably 12 month dating. It’ll depend on how our timelines for this prospective study align with our stability programs. We are VERY early in the planning stages for this project and I’d like to put together a proactive plan for managing LATAM countries under this scenario.

Our current plan involves packaging/labeling in the US and exporting finished goods to the selected LATAM countries. Are there any LATAM countries where we need to anticipate long IP import license approvals or long import/release timelines? Are there other sand traps to watch out for with short-dated IP in LATAM countries? I’d love to hear your ideas. Hoping to avoid having any labeling activities at the LATAM country specific depots.

Thanks!