Regulatory Marketing Approval definition

Regulatory Marketing Approval means, with respect to any pharmaceutical product and any Indication, Regulatory Approval (including any supplement thereto) to sell such pharmaceutical product for such Indication, including, in any jurisdiction other than the United States, to the extent required for any sale in such country, all pricing and reimbursement approvals to be obtained from the Regulatory Authority granting such Regulatory Approval or any affiliated Regulatory Authority.
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Regulatory Marketing Approval means, with respect to a particular country and a particular product, any and all approvals, licenses, registrations, or authorizations of any Regulatory Authority necessary to commercially distribute, sell, or market such product in such country, including, where applicable, (i) pricing or reimbursement approval in such country, (ii) pre- and post-approval marketing authorizations (including any prerequisite manufacturing approval or authorization related thereto), and (iii) labeling approval.
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Regulatory Marketing Approval means, with respect to any Product in any country or region and in any indication, Regulatory Approval authorizing the marketing of such Product in such country or region for such indication. For the sake of clarity, Regulatory Marketing Approval shall be deemed to have occurred when the FDA or its foreign equivalent sends a Letter of Approval or its foreign equivalent.
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Examples of Regulatory Marketing Approval in a sentence

  • Although this might appear to diminish the importance of these cells in CRS, a recent longitudinal study demonstrated that high tissue eosinophilia correlated directly with the need for revision surgery (878).

  • Eliason, Regulatory Marketing Approval for Pharmaceuticals as a Non-Tariff Barrier to Trade: Analysis under the WTO's Agreement on Technical Barriers to Trade, 8 San Diego Int'l L.J. 559 (2007) Available at: https://digital.sandiego.edu/ilj/vol8/iss2/9 This Comment is brought to you for free and open access by the Law School Journals at Digital USD.

  • Without limiting, qualifying or otherwise affecting the definition of “Net Sales” set forth in Section 1.60, sales prior to receipt of Regulatory Marketing Approval for such product, such as so-called “treatment IND sales,” “named patient sales,” and “compassionate use sales,” shall not be construed as a First Commercial Sale.

  • Eliason, Regulatory Marketing Approval for Pharmaceuticals as a Non-Tariff Barrier to Trade : Analysis Under the WTO‘s Agreement on Technical Barriers to Trade, 8 SAN DIEGO INTERNATIONAL LAW JOURNAL (2006-7) at 559.


More Definitions of Regulatory Marketing Approval

Regulatory Marketing Approval means, in respect of a particular country, a Regulatory Approval authorizing the marketing of a drug product in such country for any indication. For the sake of clarity, Regulatory Marketing Approval (a) shall be deemed to have occurred when (i) the Regulatory Authority sends a notification of such Regulatory Marketing Approval to the applicant seeking Regulatory Marketing Approval or, (ii) if Applicable Law provides for authorization for the marketing of a drug product by an action or event other than a notification, then when such action or event has been taken or occurred, and (b) shall not require that Drug Price Approval or any other Regulatory Approval has occurred.
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Regulatory Marketing Approval means, with respect to a country or region in the Territory, all technical approvals (including approvals of NDAs, supplements and amendments, pre- and post- approvals and labeling approvals), registrations or authorizations from the relevant Regulatory Authority necessary in order to Commercialize a pharmaceutical product in such country or region. For the sake of clarity, Regulatory Marketing Approval shall not be achieved for a Covered Product in a country until all applicable Price Approvals have also been obtained by Pfizer or its designee for such Covered Product in such country.
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Regulatory Marketing Approval means, in respect of a particular country, a Regulatory Approval authorizing the marketing of a device product in such country for any indication.
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Related to Regulatory Marketing 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.

  • 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.

  • 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.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • Pricing Approval means such mandatory governmental approval, agreement, determination or decision establishing prices for the 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.

  • Regulatory Approvals with respect to the Warrantholder, means, to the extent applicable and required to permit the Warrantholder to exercise this Warrant for shares of Common Stock and to own such Common Stock without the Warrantholder being in violation of applicable law, rule or regulation, the receipt of any necessary approvals and authorizations of, filings and registrations with, notifications to, or expiration or termination of any applicable waiting period under, the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.

  • 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).

  • 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 set out in Schedule C hereto;

  • 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.

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.

  • Regulatory Filing means any approvals, licenses, registrations, submissions and authorizations, and applications therefor, including IND, NDA, BLA, drug dossier or drug master file filed, or Marketing Approval obtained, with respect to an Option Product, Licensed Product or Companion Diagnostic, as applicable, in the Field, including all amendments, supplements, annual reports and the like thereof or therefor filed with or otherwise provided to the applicable Regulatory Authority.

  • Regulatory Authorities means the Commissions and the Exchange;

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

  • 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).

  • 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.

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

  • Regulatory Authority means, with respect to any national, supra-national, regional, state or local regulatory jurisdiction, any agency, department, bureau, commission, council or other governmental entity involved in the granting of a Regulatory Approval for such jurisdiction.

  • Regulatory Body means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate or investigate the matters dealt with in this Agreement or any other affairs of the Provider or the Department, including, without limitation Ofsted, the European Commission and the European Court of Auditors;

  • Regulatory Submissions means any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • FDA Approval means with respect to the Product, a Regulatory Approval by the FDA for the commercial use of the Product in the United States.

  • Regulatory Exclusivity means any exclusive marketing rights or data exclusivity rights granted by a Regulatory Authority (other than Patents) with respect to a Licensed Product sold in a given country, including orphan drug exclusivity, new chemical entity exclusivity, data exclusivity or pediatric exclusivity.

  • Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

  • FDA means the United States Food and Drug Administration.

  • Development approval means any written authorization from a