Snapshot

The Marketing Authorization Issuance according to the Accelerated Procedure pathway has been developed by the Medicines and Medical Devices Agency of Serbia of Serbia.

It is an abridged review (a reliance pathway).

Within the period of 150 days, after receiving the complete application, the Agency is obliged to decide whether to grant a marketing authorization or deny a marketing authorization application, based on the opinions and evaluation of the documentation on medicinal product quality, safety and efficacy.