European Regulatory Approval definition

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 by the European Food Safety Authority (“EFSA”).
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European Regulatory Approval means, with respect to a Product, (a) MAA approval from the EMA and pricing and reimbursement approval in three of the Major European Countries, or (b) marketing, pricing, and reimbursement approvals in three of the Major European Countries.
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Examples of European Regulatory Approval in a sentence

  • Audit of registers and files dealing with recovery, remittance and demand of fees, penalty etc., under National, Zonal and Bilateral permit schemes, including watching and checking recoveries and dues from other states and finding system defects.

  • 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.

  • The filter, designed to reduce the risk of TSE disease transmission through blood transfusions, has received European Regulatory Approval.

  • 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”).

  • 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).

  • The finding of the rare brackish angiosperm Althenia filiformis in the island of Cyprus is interesting since its insertion in the Red Data Book of the Flora of Cyprus is suggested.

  • Following European Regulatory Approval, Pfizer, directly and/or with or through Affiliates or Sublicensees, shall use Commercially Reasonable Efforts to Commercialize one Licensed Product in at least one of France, Germany, Italy or Spain.

  • 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.

  • 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.


More Definitions of European Regulatory Approval

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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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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Related to European Regulatory Approval

  • 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.

  • 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 or use of a Product as a drug in a regulatory jurisdiction.

  • 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 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 any approval, agreement, determination, or decision establishing prices that can be charged to consumers for a pharmaceutical or biological product or that will be reimbursed by Governmental Authorities for a pharmaceutical or biological product, in each case, in a country where Governmental Authorities approve or determine pricing for pharmaceutical or biological products for reimbursement or otherwise.

  • 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 in a country, territory or possession.

  • 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 from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • 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 applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of a Licensed Compound or a Licensed Product in the Territory.

  • national regulatory authority means the body or bodies charged by a Member State with any of the regulatory tasks assigned in this Directive and the Specific Directives;

  • MFDA means the Mutual Fund Dealers Association of Canada;