Device Regulatory Approval definition

Device Regulatory Approval means, with respect to a country, any and all approvals, licenses, clearances, CE marking certifications, registrations or authorizations of any Regulatory Authority necessary or useful to commercially distribute, sell or market a Product in such country, including, where applicable, (a) pricing or reimbursement approval in such country, (b) pre- and post-approval marketing authorizations (including any prerequisite manufacturing approval or authorizations related thereto), (c) Labeling approval and (d) technical, medical and scientific licenses.
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Device Regulatory Approval means, with respect to a country, any and all approvals, licenses, clearances, CE marking certifications, registrations or authorizations of any Regulatory Authority necessary or useful to commercially distribute, sell or market a Product in such country, including, where applicable, (a) pricing or reimbursement approval in such country,
Sample 1
Device Regulatory Approval means the final approval by the RHA to market a the SYSTEM with a pharmaceutical compound, but not the SYSTEM alone, in any country of the TERRITORY, including pricing and reimbursement approval and any other approval which is required to launch the SYSTEM with the pharmaceutical compound in the normal course of business. EFFECTIVE DATE shall mean 11th June, 1999. ELAN shall mean Elan Pharmaceutical Technologies, a division of Elan Corporation, plc, Elan Pharmaceutical International Limited and any of their AFFILIATES. ELAN BACKGROUND TECHNOLOGY shall mean ELAN PATENTS, and/or ELAN KNOW HOW. Notwithstanding anything contained in this Agreement to the contrary, ELAN BACKGROUND TECHNOLOGY shall consist of ELAN KNOW-HOW, and ELAN PATENTS controlled by Elan Corporation plc doing business as Elan Pharmaceutical Technologies, and shall exclude (a) inventions, patents and know-how owned, licensed or controlled by AFFILIATES of Elan Corporation, plc (other than Elan Pharmaceutical Technologies), including, without limitation, Elan Pharmaceuticals Inc., Athena Neurosciences, Inc., Carnrick Laboratories, Targon Corporation and Neurex Corporation, and (b) the Nanosystems Technology (as defined in Clause 4.2 of the MANUFACTURING AGREEMENT).
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Examples of Device Regulatory Approval in a sentence

  • AFTER THE PERIODIn August, Paxman received notification of medical device regulatory clearance in both Colombia and Uruguay.Paxman’s exclusive distribution partner for the territory of Colombia, Rocol International SAS, received INVIMA Medical Device Regulatory Approval for Paxman Scalp Cooling from the Colombia National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentosor INVIMA).


More Definitions of Device Regulatory Approval

Device Regulatory Approval means the final approval by the RHA to market the SYSTEM with the COMPOUND in any country of the TERRITORY, including pricing and reimbursement approval and any other approval which is required to launch the SYSTEM with the COMPOUND in the normal course of business. DMF shall mean Device or Drug Master File, as defined in the CFR Section 314.420 or 814 and/or its equivalent in the other countries of the TERRITORY. EFFECTIVE DATE shall mean 11th June, 1999. ELAN shall mean Elan Pharmaceutical Technologies, a division of Elan Corporation, plc, Elan Pharma International Limited and any of their AFFILIATES. ELAN BACKGROUND TECHNOLOGY shall mean ELAN PATENTS, and/or ELAN KNOW HOW. Notwithstanding anything contained in this Agreement to the contrary, ELAN BACKGROUND TECHNOLOGY shall consist of ELAN KNOW-HOW, and ELAN PATENTS controlled by Elan Corporation plc doing business as Elan Pharmaceutical Technologies, and shall exclude (a) inventions, patents and know-how owned, licensed or controlled by AFFILIATES of Elan Corporation, plc (other than Elan Pharmaceutical Technologies), including, without limitation, Elan Pharmaceuticals Inc., Athena Neurosciences, Inc., Carnrick Laboratories, Targon Corporation and Neurex Corporation, and (b) the Nanosystems Technology (as defined in Clause 4.2.).
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Related to Device 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.

  • 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;

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

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

  • 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.

  • 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.

  • 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.

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

  • 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.

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

  • 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.

  • 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.

  • 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).

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

  • 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.

  • 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.

  • Product Approvals means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that Product.

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

  • 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.

  • ANDA means Abbreviated New Drug Application.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

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

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing, and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).