Centralized Approval Procedure definition

Centralized Approval Procedure means the procedure through which a MAA filed with the EMA results in a single marketing authorization valid throughout the European Union.
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Centralized Approval Procedure means, to the extent compulsory or permitted for the Regulatory Approval of the Compound or Product in Iceland, Liechtenstein, Norway or any country in the European Union, the procedure administrated by the EMA which results in a single marketing authorization that is valid in Iceland, Liechtenstein, Norway and all countries in the European Union.
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Centralized Approval Procedure means the procedure through which an MAA filed with the EMA results in a single marketing authorization valid throughout the European Union (or at least all Major Markets that are within the European Union or otherwise subject to such marketing authorization procedure, such as the United Kingdom if and as applicable).
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Examples of Centralized Approval Procedure in a sentence

  • At least [...***...] months prior to the anticipated filing of the first Drug Approval Application with the applicable Regulatory Authority in any country in the Co-Promotion Territory (or with the EMA with respect to the Centralized Approval Procedure), or such other period as the Parties may agree in writing, AbbVie shall propose to the JCC the initial Co-Promotion Plan.

  • The Contractor shall at all times have on the Site suitable and sufficient plant and materials to adequately protect, support and sustain any and all existing structures and facilities, whether above or below ground, and shall use same as may be necessary or required to protect, support and sustain any and all such structures as may become weakened, endangered, undermined or uncovered.


More Definitions of Centralized Approval Procedure

Centralized Approval Procedure means the procedure through which an MAA filed with the EMA results in a single marketing authorization valid throughout the European Union (or at least all continental Major European Countries that are within the European Union).
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Centralized Approval Procedure means, to the extent compulsory or permitted for the Marketing Approval of a pharmaceutical product in Iceland, Liechtenstein, Norway or any country in the European Union, the procedure administrated by the EMA which results in a single Marketing Approval granted by the European Commission (excluding any pricing or reimbursement approval) that is valid in all countries in the European Union and following recognition, Iceland, Liechtenstein and Norway.
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Centralized Approval Procedure means, to the extent compulsory for the Regulatory Approval of Compounds and Products, the procedure administrated by the EMA which results in a single marketing authorization that is valid in all European Union countries, as well as in Iceland, Liechtenstein and Norway.
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Centralized Approval Procedure means the procedure through which an MAA filed with the EMA results in a single marketing authorization valid throughout the European Union. 1.12 “Change of Control” means, with respect to a Party: (a) a transaction in which such Party (or a Holding Company of such Party) sells, conveys or otherwise disposes of all or substantially all of its property or business; or (b) (i) a transaction in which such Party (or a Holding Company of such Party) merges or consolidates with any other Person (other than a wholly-owned subsidiary of such Party or a Holding Company of such Party), or (ii) any other transaction or series of transactions; in each case of clause (i) or (ii), in consequence of which any Person and/or any group of Persons acting in concert (as such expression is defined in the Code) acquires a Controlling Interest in such Party (or in a Holding Company of such Party). For the purposes of Sections 1.12 or 1.107, the following capitalized terms shall have the meanings set out below:
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Centralized Approval Procedure means the procedure under Regulation (EC) 726/2004 through which a MAA filed with the European Medicines Agency results in a single marketing authorization valid in all European Union member states, Iceland, Norway and Liechtenstein.
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Related to Centralized Approval Procedure

  • Staff Vetting Procedure means the Authority’s procedures for the vetting of personnel and as advised to the Contractor by the Authority.

  • Direct Ordering Procedure means the ordering procedure set out in paragraph 2 of Schedule 5 (Ordering Procedure) of this Framework Agreement;

  • Project Implementation Plan means the detail plan submitted by the Developer with regard to development of Project Facilities and its operation and management thereof in accordance with this Agreement and to be appended as Schedule 9 to this Agreement.

  • Project Implementation Manual or “PIM” means the manual setting out the measures required for the implementation of the Project, as the same may be amended from time to time, subject to prior approval of the Association;

  • AML/KYC Procedures means the customer due diligence procedures of a Reporting Finnish Financial Institution pursuant to the anti-money laundering or similar requirements of Finland to which such Reporting Finnish Financial Institution is subject.

  • Interconnection Feasibility Study means either a Generation Interconnection Feasibility Study or Transmission Interconnection Feasibility Study.

  • Bidding Procedures means the procedures governing the Auction and sale of all or substantially all of the Debtors’ assets, as approved by the Bankruptcy Court and as may be amended from time to time in accordance with their terms.

  • service delivery and budget implementation plan means a detailed plan approved by the executive mayor of a municipality in terms of section 53(l)(c)(ii) of the MFMA for implementing the municipality's delivery of municipal services and its annual budget, and which must indicate

  • Generation Interconnection Feasibility Study means a study conducted by the Transmission Provider (in coordination with the affected Transmission Owner(s)) in accordance with Tariff, Part IV, section 36.2.

  • Grievance Procedure is used in this Agreement, it shall be considered as including the arbitration procedure.

  • Bidding Process means the procurement procedure under which sealed bids are invited, received, opened, examined and evaluated for the purpose of awarding a contract;

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Large Facility Interconnection Procedures or “LFIP”) shall mean the interconnection procedures applicable to an Interconnection Request pertaining to a Large Generating Facility that are included in Attachment X of the NYISO OATT. Standard Large Generator Interconnection Agreement (“LGIA”) shall mean this Agreement, the form of interconnection agreement applicable to an Interconnection Request pertaining to a Large Generating Facility, that is included in Attachment X of the NYISO OATT. System Deliverability Upgrades shall mean the least costly configuration of commercially available components of electrical equipment that can be used, consistent with Good Utility Practice and Applicable Reliability Requirements, to make the modifications or additions to Byways and Highways and Other Interfaces on the existing New York State Transmission System and Distribution System that are required for the proposed project to connect reliably to the system in a manner that meets the NYISO Deliverability Interconnection Standard at the requested level of Capacity Resource Interconnection Service. System Protection Facilities shall mean the equipment, including necessary protection signal communications equipment, required to (1) protect the New York State Transmission System from faults or other electrical disturbances occurring at the Large Generating Facility and (2) protect the Large Generating Facility from faults or other electrical system disturbances occurring on the New York State Transmission System or on other delivery systems or other generating systems to which the New York State Transmission System is directly connected. System Upgrade Facilities shall mean the least costly configuration of commercially available components of electrical equipment that can be used, consistent with Good Utility Practice and Applicable Reliability Requirements, to make the modifications to the existing transmission system that are required to maintain system reliability due to: (i) changes in the system, including such changes as load growth and changes in load pattern, to be addressed in the form of generic generation or transmission projects; and (ii) proposed interconnections. In the case of proposed interconnection projects, System Upgrade Facilities are the modifications or additions to the existing New York State Transmission System that are required for the proposed project to connect reliably to the system in a manner that meets the NYISO Minimum Interconnection Standard. Tariff shall mean the NYISO Open Access Transmission Tariff (“OATT”), as filed with the Commission, and as amended or supplemented from time to time, or any successor tariff. Trial Operation shall mean the period during which Developer is engaged in on-site test operations and commissioning of the Large Generating Facility prior to Commercial Operation.

  • Final Approval Hearing means the hearing before the Court where the Parties will request the Final Judgment to be entered by the Court approving the Settlement Agreement, the Fee Award, and the incentive award to the Class Representative.

  • Staff Vetting Procedures means the Authority’s procedures for the vetting of personnel and as advised to the Contractor by the Authority.

  • MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.

  • Final Approval Order means the order and final judgment approving the Settlement Agreement, implementing the terms of this Settlement Agreement, and dismissing the Class Action with prejudice, to be proposed by the Settling Parties for approval by the Court, in substantially the form attached as Exhibit 5 hereto.

  • Federal work authorization program means any of the electronic verification of work authorization programs operated by the United States Department of Homeland Security or any equivalent federal work authorization program operated by the United States Department of Homeland Security to verify information of newly hired employees, pursuant to the Immigration Reform and Control Act of 1986 (IRCA), D.L. 99-603.

  • Project Implementation means all steps which the Grantee undertakes in order to deliver the Project which is being supported by funding provided under this Grant Contract. Any reference to UK primary legislation (Acts) or secondary legislation (Statutory Instruments) in this Grant Contract includes reference to any changes to or replacement of those Acts or Statutory Instruments.

  • commercial air transport means an aircraft operation involving the transport of passengers, cargo, or mail for remuneration or hire.

  • NZOC Nomination and Selection Regulation means the regulation of NZOC relation to the nomination and selection Process for all Olympic and Commonwealth games, including the Games.

  • Dispute Resolution Procedure means the procedure for resolution of Disputes set forth in Article 26;

  • Dispute Resolution Procedures means the procedures outlined in Annexure A of the MSA Determination.

  • Change Control Procedure has the meaning set out at Clause 28.1;

  • Project Implementation Unit or “PIU” means the unit referred to in Section I.A.1 of Schedule 2 to this Agreement.