European Regulatory Approval definition

European Regulatory Approval means, with respect to a Licensed Product, the Regulatory Approval of such Licensed Product by the EMA and the European Commission.
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European Regulatory Approval means Regulatory Approval by the European Food Safety Authority (“EFSA”).
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European Regulatory Approval means a marketing authorization issued by the EMEA applying to one or more or all European Union Members.
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Examples of European Regulatory Approval in a sentence

  • Dr. Costa notified the auditor responsible for the EU application that he was “the sole owner of the Phase II Study” and that “TheraBionic had no right to reference or rely on the Phase II Study in its European Regulatory Approval Application.” (Doc.

  • Upon the completion of either US Regulatory Approval or European Regulatory Approval, Nestlé will use its reasonable endeavors to implement and complete a concept and products acceptance test within a period of [***] to ascertain the commercial potential of Products (e.g. product concept development, consumer testing etc).

  • Following Phase 3 Success and receipt of the Data Package from Sxxxx, Pfizer, directly and/or with or through Affiliates or Sublicensees, shall use Commercially Reasonable Efforts to seek European Regulatory Approval for the HAP/VAP Indication.

  • Biotronik will obtain and maintain in its own name and at its own expense all required regulatory approvals for sale of the Product in the United States and required European Regulatory Approval for the Products in the European Union (CX-Xxxx).

  • If BSC or BSC's subdistributors have [ ** ], the term hereof in Europe will expire at 11:59 p.m. Massachusetts time on the later to occur of (i) the date that is five (5) years after the Effective Date or (ii) the date that is thirty-six (36) months after the European Regulatory Approval Date.

  • The new district improvement plan was scheduled for completion in 2004.

  • If BSC has not [ ** ], the term hereof in Europe will expire at 11:59 p.m. Massachusetts time on the date that is thirty-six (36) months after the European Regulatory Approval Date but not later than January 21, 2003.

  • The Data Package for a Collaboration Compound shall include the information set forth in Appendix B, including, without limitation, SENOMYX’s preliminary plan to pursue Regulatory Approval for the specified Collaboration Compound in Major Countries and, to the extent requested by PEPSICO, European Regulatory Approval (“Initial Regulatory Plan”).

  • Introduction‌ 1.1 Defining masting‌Masting is a synchronous and highly variable production of seeds in tree species [1].


More Definitions of European Regulatory Approval

European Regulatory Approval means Regulatory Approval from the EMA or the applicable Regulatory Authority in any of the [***] major European markets [***].
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European Regulatory Approval means Regulatory Approval from the European Medicines Agency or any successor entity thereto or the applicable Governmental Authority in any one of the five major European markets (France, Germany, Italy, Spain or the United Kingdom).
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European Regulatory Approval means, with respect to a Licensed Product and a particular Indication: (a) Regulatory Approval of such Licensed Product for such Indication in […***…] Major European Markets, by the European Commission (in the case of any Major European Markets other than the United Kingdom) or the MHRA (in the case of the United Kingdom) and (b) Pricing Approvals for such Licensed Product for such Indication in such Major European Markets, by the European Commission (in the case of any Major European Markets other than the United Kingdom) or the MHRA (in the case of the United Kingdom).
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European Regulatory Approval means, with respect to a Product, MAA approval from the European Commission (i.e., European Union-wide) or in [***] or more of the Major European Countries.
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Related to European Regulatory Approval

  • 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.

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

  • 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.

  • 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.

  • 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;

  • 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.

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

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

  • 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.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Pricing Approval means such governmental approval, agreement, determination or decision establishing prices for a Licensed Product that can be charged and/or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price and/or reimbursement of pharmaceutical products.

  • 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).

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

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

  • 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.

  • Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • foreign regulatory authority means a securities commission, exchange or other securities market regulatory authority in a designated foreign jurisdiction;

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.

  • 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.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • Regulatory Authority means any federal, national, multinational, state, county, city, provincial, or local regulatory agency, department, bureau or other governmental entity with authority over the marketing, commercialization, manufacture or sale of a pharmaceutical product in the Territory, including the FDA in the United States and the EMA in the EU.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.