Snapshot

The Urgent Procedure for biotechnological medicinal products pathway has been developed by the of Uruguay.

This pathway can be used where The "Urgent Procedure" is for applications for registration and modifications to registration data of Biotechnological Medicines that have a certificate of pharmaceutical product issued by the FDA or EMA (Original Biotechnological Medicines or Similar Biotechnological Medicines)..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

40 business days max. NB: Biotechnological medicines that the Department of Medicines cannot evaluate within 40 days are exempt from the "Urgent Procedure".