European Approval definition

European Approval means all Regulatory Approvals necessary for selling and marketing a Product in an European Major Market Country.
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European Approval has the meaning set forth in Section 8.04(a).
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European Approval or "European Registration" will mean the approval of the Product (as hereinafter defined) for marketing by the European Commission
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Examples of European Approval in a sentence

  • Microsoft may provide additional information in the Xbox 360 Publisher Guide regarding the European Approval Option.

  • Likewise, the USCG is able to issue the European Approval (MED/wheelmark) for manufacturers having a USCG approval if the item is included within the scope of the MRA.

  • The MRA makes it possible for a manufacturer with a European Approval (MED/wheelmark) to obtain USCG approval for certain equipment covered by the MRA.

  • Likewise, the USCG will be able to issue the European Approval (MED/Wheelmark) for manufacturers having a USCG approval if the item is included within the scope of the MRA.

  • Microsoft may provide additional information in the Xbox 2 Guide regarding the European Approval Option.

  • This US/EC MRA makes it possible for a manufacturer with a European Approval (MED/wheelmark) to obtain USCG approval covered by the MRA.

  • The Borrowers shall have paid to each Lender that executes and returns this Amendment to the Administrative Agent prior to 5:00 p.m. Eastern Time on March 7, 2003, a fee equal to 0.125% of such Lender's Revolving Loan Commitment after giving effect to the Revolving Loan Commitment reduction effected hereby.

  • In the event that a Vendor or Vida does not so notify the Purchaser within 30 Business Days of receipt of FEA Notice such Vendor or Vida, in respect of itself and not in respect of any other party, shall be deemed to have elected that the FEA Obligation be satisfied by the issue of the First European Approval Shares.

  • Materials which comply with available Harmonized Standard(s) are presumed to be in conformity with the PED.- covered by European Approval of Materials - European Approval of Materials is a technical document defining the characteristics of materials intended for repeated use in the manufacture of pressure equipment not covered by a harmonized standard.

  • The Company and Parent will consult and cooperate with one another, and will consider in good faith the views of one another, in connection with any analysis, appearance, presentation, memorandum, brief, argument, opinion or proposal made or submitted in connection with any legal or administrative proceeding under or relating to the HSR Act, the Exon-Xxxxxx Provision, the DOT Approval, the European Approval, or any other federal, state or foreign antitrust or fair trade law.


More Definitions of European Approval

European Approval means Regulatory Approval of a BLA by EMA or the MHRA, as applicable, [***].
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European Approval means Marketing Approval in the European Union, the member states of which as of the Effective Date are Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.
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European Approval means Regulatory Approval of a Product in any country in Europe, including any approval from the EMA or MHRA.
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Related to European Approval

  • 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.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • CFIUS Approval means that any of the following shall have occurred: (a) the review period under the DPA commencing on the date that a CFIUS Notice is accepted by CFIUS shall have expired and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS to the effect that such review has been concluded and that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, (b) an investigation under the DPA shall have been commenced after such review period and CFIUS shall have determined to conclude all action under the DPA without sending a report to the President of the United States, and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, or (c) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (i) the President shall have announced a decision not to take any action to suspend or prohibit the Contemplated Transactions or, (ii) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Contemplated Transactions shall have expired without any such action being threatened, announced or taken.

  • European Commission means the authority within the European Union that has the legal authority to grant Regulatory Approvals in the European Union based on input received from the EMA or other competent Regulatory Authorities.

  • Government Approval means any authorization, consent, approval, waiver, exception, variance, order, exemption, publication, filing, declaration, concession, grant, franchise, agreement, permission, permit, or license of, from or with any Governmental Authority, the giving notice to, or registration with, any Governmental Authority or any other action in respect of any Governmental Authority.

  • HSR Approval means expiration of all applicable waiting periods under the HSR Act (including any voluntary agreed extensions) or earlier termination thereof.

  • Application Approval Date means the date that the Application is approved by the Board of Trustees of the District and as further identified in Section 2.3.B of this Agreement.

  • Approval Authority means the authority of a Member State with competence for all aspects of the approval of a type of vehicle, system, component or separate technical unit or of the individual approval of a vehicle; for the authorisation process, for issuing and, if appropriate, withdrawing approval certificates; for acting as the contact point for the approval authorities of other Member States; for designating the technical services and for ensuring that the manufacturer meets his obligations regarding the conformity of production;

  • FDA Approval means the approval, license, clearance or authorization of the FDA necessary for the marketing and sale of a product for human use in the United States.

  • Price Approval means, in any country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).

  • European Community means the territory comprised by the Member States of the European Community as constituted from time to time;

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • FCC Approval means the FCC’s grant of the FCC Applications, including any grants by operation of law; provided that the possibility that an appeal, request for stay, or petition for rehearing or review by a court or administrative agency may be filed with respect to such grant, or that the FCC may reconsider or review such grant on its own authority, shall not prevent such grant from constituting FCC Approval for purposes of the Plan.

  • 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.

  • Major European Country means any of France, Germany, Italy, Spain or the United Kingdom.

  • type-approval means the procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements;

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Major European Countries means France, Germany, Italy, Spain and the United Kingdom.

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • Development approval means a document from a governmental entity which authorizes the commencement of a development.

  • European Communities means the European Economic Community, the European Coal and Steel Community and the European Atomic Energy Community.

  • Requisite Approval means the affirmative vote of the holders of at least a majority of the shares of outstanding Company Common Stock and outstanding Company Preferred Stock voting as a single class.

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • Website of the European Central Bank means the website of the European Central Bank currently at http://www.ecb.europa.eu or any successor website officially designated by the European Central Bank.