ILPTO Update: Another IL PTE Revoked For Late Reporting Of Foreign PTE/SPCs
In a recent decision, the ILPTO reiterated that late reporting of the grant of PTE/SPCs in the Recognized Countries (US and the EU-5 Countries) may result in loss of PTE eligibility and revoked Amgen’s PTE for OTELZA. In accordance with the ‘Two-State Requirement’, when marketing authorizations for a new medical preparation have been granted in […]