Centralized Procedure definition
Examples of Centralized Procedure in a sentence
Currently the three main types of procedures recognized for the granting of a marketing authorization and to place a product on the market in Malta are the National Procedures, European Procedures (Mutual Recognition and Decentralized Procedures), and Centralized Procedure.
The Centralized Procedure is optional for products containing a new active substance not yet authorized in the EEA, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health in the EU.
Theproduct was approved through the Centralized Procedure which enabled marketing of the product in all EU member States.
Amount of PSN Funds Requested • Indicate the exact amount of federal funds being requested.
Before the Effective Date of this Agreement, AcelRx has obtained clearance from the EMA that the Licensed Product can (but need not) be submitted through a Centralized Procedure and has submitted a respective letter of intent to the EMA and has requested a corresponding pre-submission meeting with the EMA and Grünenthal has received a copy of such documentation.