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

  • 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.

  • Furthermore, AcelRx has initiated the clearance procedure(s) regarding the AcelRx Trademarks to be used for the commercialization of the Licensed Product under the EMA in accordance with the Centralized Procedure.

  • UNION application via the Centralized Procedure that the NDA is sufficiently complete to permit a substantive review.

  • For example, a manufacturer who applies to have its drug approved by the European Medicines Agency198 may have a denial reviewed by the European Court of Justice.199 Similarly, 198 This is specifically referring to the Centralized Procedure.

  • Should the MAA be submitted via a Centralized Procedure, PolyPid shall effect such filing.


More Definitions of Centralized Procedure

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 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 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: [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
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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 the European Union-wide procedure for receipt of the MA for the Product from the EMA, where there is a single application, a single evaluation and a single authorisation for the Product throughout the European Union.
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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 submission of an MAA to the EMA using the centralised procedure.
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