Centralized Procedure definition

Centralized Procedure means the European Union Centralized Procedure for marketing authorization in accordance with Council Regulation n° 2309/93 of July 22, 1993 or any successor regulations.
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Centralized Procedure means the European Community Centralized Procedure for marketing authorization in accordance with Council Regulation EEC (2309-93) or any successor regulations.
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Centralized Procedure means the procedures of the EU for obtaining marketing authorisation for a medicinal product as set forth in Regulation (EC) No 726/2004 of 31 March 2004, as amended from time to time during the Term.
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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.


More Definitions of Centralized Procedure

Centralized Procedure means, to the extent compulsory or permitted for the Regulatory Approval of a pharmaceutical product in Iceland, Liechtenstein, Norway, or any country in the EU, the procedure administrated by the EMA which results in a single Regulatory Approval granted by the European Commission (excluding any pricing or reimbursement approval) that is valid in all countries in the EU and, following recognition, in Iceland, Liechtenstein and Norway.
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Centralized Procedure means the procedure through which a Drug Approval Application filed with the EMA results in a single marketing authorization valid throughout the European Union.
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Centralized Procedure means the procedure for the authorization and supervision of medicinal products for human use set forth in Council Regulation (EEC) No. 2309/93 (the “Regulation”).
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Centralized Procedure means the centralized procedure for obtaining a Marketing Authorization in the European Union as set forth in Regulation (EC) 726/2004. 3. A new Section 1.47 shall be inserted to define “European Territory” as follows:
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Centralized Procedure means the procedures of the EU for obtaining marketing authorisation for a medicinal product as set forth in
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Centralized Procedure means, to the extent compulsory or permitted for the Regulatory Approval of a pharmaceutical product in [ * ] any country in the EU, the procedure administrated by the EMA which results in a single Regulatory Approval granted by the European Commission (excluding any pricing or reimbursement approval) that is valid in all countries in the EU and following recognition, [ * ] .
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Centralized Procedure means submission of an MAA to the EMA using the centralised procedure.
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