Product Applications definition

Product Applications means all applications for Product Approval filed with respect to Products Under Registration, with each individual application being a “Product Application”;
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Product Applications has the meaning ascribed thereto in Section 10(g) of Schedule C;
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Product Applications means each new drug application, abbreviated new drug application or investigational new drug application or other application or other filings seeking to allow for the manufacturing, distribution, sale, marketing or investigation of a pharmaceutical product (or similar applications or filings in jurisdictions outside the United States) that has been filed with, or submitted to, the FDA (or similar Governmental Entity outside the United States), in each case as amended, and has not been approved or authorized by the FDA (or similar Governmental Entity outside the United States).
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Examples of Product Applications in a sentence

  • Please submit these labeling electronically according to the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.

  • Please submit these labeling electronically according to the guidance for industry titled Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (April 2018, Revision 5).

  • FDA, “Premarket Tobacco Product Applications and Recordkeeping Requirements,” 84 Federal Register 50566, September 25, 2019.

  • This is an opt-in scheme eligible for applicants who make payment via GIRO and is only applicable to the application types listed in Table 3: Table 3 Product Applications Applicable for Progressive Payment Scheme Once the application is submitted, the selected payment scheme (full or progressive) cannot be amended.

  • Please submit these labeling electronically according to the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (April 2018, Revision 5).

  • Please submit these labels electronically according to the guidance for industry Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (June 2008).

  • Please submit these labels electronically according to the guidance for industry titled “Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (June 2008)”.Alternatively, you may submit 12 paper copies, with 6 of the copies individually mounted on heavy-weight paper or similar material.

  • Please submit these labels electronically according to the guidance for industry titled Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (October 2005).

  • We submitted our Premarket Tobacco Product Applications (PMTA) to the Food and Drug Administration, seeking authority to continue the marketing of a range of blu vapour products including my blu, blu PLUS and blu Disposable, with various nicotine strengths and flavours.Adjusted operating profit was 3.4 per cent lower at constant currency, reflecting NGP losses and lower tobacco profit.The NGP losses were driven by a £48 million write-down of flavoured inventory following the FDA ban and lower NGP sales.

  • If you are not sure if the site should 7 For additional information, see guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (July 2019).


More Definitions of Product Applications

Product Applications means ANDAs and other submissions to any national, international or local governmental regulatory authority for approvals, registrations, permits, licenses, consents, authorizations, or other approvals to research, develop, manufacture, distribute, finish, package, market, sell, store or transport a Product, together with all supplements, amendments, and revisions to such submissions, all preparatory work, drafts and data necessary for the preparation of such submissions, and all correspondence between Respondents and the relevant national, international or local governmental authority relating to such submissions.
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Product Applications means (i) the application for approval or registrations by the Selling Parties and its Affiliates, for the investigation, sale, distribution and/or marketing of the Product in the Territory set forth on Schedule 1.1(k), and (ii) all dossiers, reports, data and other written materials prepared by or filed as part of such applications for approvals or registrations, or maintained by the Selling Parties and its Affiliates and relating to such applications for approvals or registrations.
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Related to Product Applications

  • Project Application means the federal Section 5311 operating assistance project application submitted by the Municipal Corporation to, and as approved by the Commissioner for the Project described in Appendix C of this Agreement, including all project supporting information submitted therewith.

  • Patent Applications means all published and unpublished nonprovisional and provisional patent applications, reexamination proceedings, invention disclosures and records of invention, applications for certificates of invention and priority rights, in any country and regardless of formal name, including without limitation, substitutions, continuations, continuations-in-part, divisions, renewals, revivals, reissues, re-examinations and extensions thereof.

  • SAP Application(s) means all Packages (i.e. all Software and Third Party Software) licensed under the Agreement and/or SAP cloud services for which Customer has a valid subscription, excluding User Interfaces for ERP, SAP Technology Solutions and all database Packages.

  • Client Application means an application developed by Customer that a) utilizes the Runtime Product, b) is installed fully on an end user’s machine, with all report processing local to that machine, and c) adds significant and primary functionality to the Runtime Product.

  • Third Party Applications means online, Web-based applications and offline software products that are provided by third parties and are identified as third-party applications, including but not limited to those listed on the AppExchange and the Reseller Application.

  • Patent Application means an application for patent protection for a CRADA Subject Invention with the United States Patent and Trademark Office (“U.S.P.T.O.”) or the corresponding patent-issuing authority of another nation.

  • Account Application or “Application” shall mean the application, as may be amended from time to time, by which this Agreement is established between the Depositor (or following the death of the Depositor, the Beneficiary) and the Custodian. The statements contained therein shall be incorporated into this Agreement.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to develop, manufacture, market, sell or otherwise commercialize a product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, XXXx and NDAs (as applications, but not the approvals with respect thereto).

  • 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).

  • Software Application means a digital product or service as defined in Article 2, point 13, of Regulation (EU) …/… [on contestable and fair markets in the digital sector (Digital Markets Act)];

  • Licensed Application means an Application that (a) meets and complies with all of the Documentation and Program Requirements, and (b) has been selected and digitally signed by Apple for distribution, and includes any additional permitted functionality, content or services provided by You from within an Application using the In-App Purchase API.

  • Product Patents means any Patent Controlled or owned by Quoin in the Territory that, absent the license in Section 2.1, would be infringed by the importation, sale, or use of the Product in the Territory by a third party.

  • international application means an application filed under this Treaty;

  • 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).

  • Access Application means an application for Access Rights as described in section 3.7;

  • Product Know-How means Know-How

  • Application Process means the online application process under which the Applicant applies for Hospitality Packages on the Webshop.

  • 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.

  • Provider Platform Application means an application or a set of related functionality deployed on a Platform Cloud Service, created by Provider using the Tools to run on or with the Platform Cloud Service for access by End Users.

  • Regulatory Documentation means all applications, registrations, licenses, authorizations and approvals (including all Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), all supporting documents and all Clinical Trials and tests, including the manufacturing batch records, relating to a Product, and all data contained in any of the foregoing, including all regulatory drug lists, advertising and promotion documents, adverse event files and complaint files.

  • Patent Cooperation Treaty means the Patent Cooperation Treaty done at Washington on June 19, 1970;

  • Practical application means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are, to the extent permitted by law or government regulations, available to the public on reasonable terms.

  • 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.

  • Commercial applicator means any person, unless exempted in I(4) hereunder, whether or not the person is a private applicator with respect to some uses, who:

  • Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.