Japan Approval definition

Japan Approval means all Regulatory Approvals necessary for selling and marketing a Product in Japan.
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Japan Approval means the grant of Marketing Authorization in Japan.
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Japan Approval means Marketing Approval by the Japanese Korosho pursuant to Japanese Korosho Regulations, policies or guidelines in effect for the commercial sale of a Collaboration Product.
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Examples of Japan Approval in a sentence

  • Retrieved October 28, 2011, from http://www.auditor.leg.state.mn.us/ped/pedrep/9605ful.pdfOhio Association for Gifted Children.

  • Factors (a) to (h) of the MOU between SA and Mauritius outlined above are closely aligned to the New IN6 of SA with exception to one factor (f) above which is not aligned to the New IN6.The Competent Authorities identified in the MOU to determine who has taxing rights are the Chief Officer: Legal and Policy, SARS duly representing the SARS and the Financial Secretary and the Ministry of Finance and Economic Development, duly representing the Mauritius Revenue Authority.

  • Declarations Ethics approval and consent to participate The study was approved by the Medical Ethics Committee of the School of Medicine, Keio University, Tokyo, Japan (Approval No 20110264).

  • The samples were analyzed in the Toxicology Laboratory at the Faculty of Veterinary Medicine, Hokkaido University, Sapporo, Japan (Approval Number: Vet-17010).

  • Dyslipidemia medication, gender and number of years of education were associated with discordance in self-reporting.AbbreviationsNHI:National Health Insurance; ATC:Anatomical Therapeutic Chemical; WHO:World Health Organization; 95% CIs:95% confidence intervals; ORs:Odds ratios; SD:standard deviation.Declarations Ethics approval and consent to participate The study was approved by the Medical Ethics Committee of the School of Medicine, Keio University, Tokyo, Japan (Approval No 20110264).

  • Certain B-cell NHL U.S.: Approved Genentech (U.S. European Union: copromotion) Approved Roche (worldwide except Japan: Approval U.S. and Japan) Zenyaku pending (Japan) ZEVALIN............................

  • Wireless devices which are marketed and sold in Japan comes under authority of JATE i.e. Japan Approval Institute for Telecommunication Equipment.

  • Declarations ETHICS APPROVAL AND CONSENT TO PARTICIPATE The study was performed in accordance with the Declaration of Helsinki and was approved by the Human and Animal Ethics Review Committee, of the University of Occupational and Environmental Health, Japan (Approval numbers: H25-109 and H27-094) and by each institutional review board.

  • New York Switzerland UK Italy Japan Approval of collectors and processors Government Figure 4.6 Roles of Government and TPO in practiceGovernment Government entities may be tasked with managing take-back systems.

  • Self-reported medication use The study was approved by the Medical Ethics Committee of the School of Medicine, Keio University, Tokyo, Japan (Approval No 20110264).

Related to Japan 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.

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

  • 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.

  • 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.

  • 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.

  • Development approval means any written authorization from a

  • 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).

  • Government Approval means an approval, permit, license, authorization, certificate, or consent of any Governmental Authority.

  • 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.

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

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Development Approvals means all permits, licenses, and/or other entitlements for the Development of the Property, including any and all conditions of approval, subject to approval or issuance by the City in connection with Development of the Property including:

  • Non-Approval Event means, in respect of the Benchmark:

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • Pre-approval means written notification via a pre-approval letter to Customer that Ameren Illinois has reviewed Customer's Application and determined that the project meets the program eligibility requirements for a maximum pre-approved incentive amount if the project is completed by the estimated completion date and all final application paperwork is submitted and approved.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Requisite Approval means the affirmative vote of the holders of (a) at least a majority of the outstanding shares of Company Capital Stock, voting together as a single class and (b) at least a majority of the outstanding shares of Series A-1 Preferred Stock, Series B Preferred Stock and Series C Preferred Stock, voting together as a single class on an as-converted basis.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Final Approval means the Court’s order granting final approval of the Settlement.

  • 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.

  • 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;