Snapshot

The INVIMA Exceptional Circumstances (Decree 481) pathway has been developed by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos of Colombia.

This pathway can be used where vital unavailable medicines.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Canada Denmark France Germany Japan Netherlands Norway Sweden Switzerland United Kingdom United States

Authorisation may take from 15 days to two months to be issued. However, during the VUM import application assessment, the MRC may require the applicant to submit an application for pharmacological evaluation first, which may take up to four months.