Snapshot

The Simplified Authorization Procedure (Art. 14) pathway has been developed by the of Switzerland.

This pathway can be used where Human and veterinary products..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from EU-EMA Europe

The time limits for the procedure according to Art. 14 para. 1 letter abis TPA are based on the application type (e.g. NA KAS, NA NAS or type II IE also possible). The time limits for the various application types are described in the "Guidance document Time limits for authorisation applications HMV4" (See References Below).