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, to the extent compulsory or permitted for the Regulatory Approval of a 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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Examples of Centralized Approval Procedure in a sentence

  • In the event Ablynx exercises the Co-Promotion Option, at least […***…] 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), the Parties shall establish a joint commercialization committee (the “Joint Commercialization Committee” or “JCC”).

  • In order to exercise the Co-Promotion Option, no later than […***…] ([…***…]) 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), Galapagos must provide AbbVie with written notice of its election to exercise the Co-Promotion Option with respect to the Co-Promotion Territory.

  • 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), the Parties shall establish a joint commercialization committee (the “Joint Commercialization Committee” or “JCC”).

  • 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.

  • 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.

  • AbbVie shall provide Galapagos with at least […***…] ([…***…]) years prior written notice of the anticipated filing date for the first Drug Approval Application for any Co-Promotion Product with the applicable Regulatory Authority in any country in the Co-Promotion Territory (or with the EMA with respect to the Centralized Approval Procedure).

  • AbbVie shall provide Galapagos with at least [...***...] years prior written notice of the anticipated filing date for the first Drug Approval Application for any Co-Promotion Product with the applicable Regulatory Authority in any country in the Co-Promotion Territory (or with the EMA with respect to the Centralized Approval Procedure).

  • In order to exercise the Co-Promotion Option, no later than [...***...] 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), Galapagos must provide AbbVie with written notice of its election to exercise the Co-Promotion Option with respect to the Co-Promotion Territory.

  • 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), the Parties shall establish a joint commercialization committee (the “Joint Commercialization Committee” or “JCC”).


More Definitions of Centralized Approval Procedure

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 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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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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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;

  • Approved/Approval means the approval in writing.

  • 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;

  • Required Approval has the meaning specified in Section 2.2(b).

  • 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 mayor of a municipality in terms of section 53(1) (c) (ii) for implementing the municipality’s delivery of municipal services and its annual budget.

  • HUB Subcontracting Plan or “HSP” means written documentation regarding the use of subcontractors, which is required to be submitted with all responses to state agency contracts with an expected value of $100,000.00 or more where subcontracting opportunities have been determined by the state agency to be probable. The HUB subcontracting plan subsequently becomes a provision of the awarded Contract and shall be monitored for compliance by the state agency during the term of the Contract.

  • 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.

  • 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 of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Final Approval Order means the proposed Order Granting Final Approval to the Settlement, to be entered by the Court with terms to be agreed upon by the Parties and consistent with this Agreement.

  • 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.

  • 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 resolving disputes as set out in Clause 17 (Dispute Resolution);

  • 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;