European Approval definition

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

Examples of European Approval in a sentence

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

  • 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 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.

  • 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.

  • 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.

  • Fukutome T, Amaha K, Nakazawa K, Kawamura T, Noguchi H: Tracheal intubation through the intubating laryngeal mask airway (LMA-Fastrach) in patients with difficult airways.

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

  • It is important to first take a look at what affects students reading attitudes in order to better understand where the influences affecting attitude arrive.

  • The minutes shall be available to the Members at the Association’s premises and shall be store in an adequate manner.

  • Data are shown for the nucleon made of degenerate valence quarks at the nine available masses.


More Definitions of European Approval

European Approval has the meaning set forth in Section 8.04(a).
European Approval means Regulatory Approval of a Product in any country in Europe, including any approval from the EMA or MHRA.
European Approval means Regulatory Approval of a BLA by EMA or the MHRA, as applicable, [***].

Related to European Approval

  • 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:

  • 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 European Commission or any successor entity that is responsible for granting Marketing Approvals authorizing the sale of pharmaceuticals in the European Union.

  • Government Approval means (a) any authorization, consent, approval, license, lease, ruling, permit, tariff, rate, certification, waiver, exemption, filing, variance, claim, order, judgment or decree of, by or with, (b) any required notice to, (c) any declaration of or with or (d) any registration by or with, any Government Authority.

  • 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 by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • FCC Approval means the FCC’s grant of the FCC Applications; 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.

  • 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;

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

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

  • Development approval means any written authorization from a

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

  • 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.