Category 3 application definition

Category 3 application means a complete application which is categorised for consideration and decision making by the Head;
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Examples of Category 3 application in a sentence

  • This becomes one of the redundant channels for a Category 3 application.

  • As such MSD would like to propose that as part of this review process the TGA amend the guidelines to provide more clarity on the average processing times for the Category 3 application from the time the product is received by the TGA to the time it is accepted into evaluation.

  • If the Final Benefits Sharing Statement provided at placed in service does not demonstrate that the financial benefits requirements are met as planned, the applicant will be disqualified.Example 1: Calculating the gross financial value of the annual energy produced by the facility• The owner of a Qualified Residential Property is submitting a Category 3 application for a 50 kW solar facility that they will also own.

  • This can then be used as a guide by the industry.MSD has noted that the revised guidelines do not provide any clarity on the time it takes to process a Category 3 application starting from the time an application is received by the TGA to the time it is accepted into evaluation and shows up on TGA eBS.

  • The coefficients for counseling type/provider, however, generally are quite a bit larger in absolute value.

  • However, as stated earlier MSD disagrees with this minimum 6 month requirement given the 45-working day timeframe for a decision to be provided for a Category 3 application.

  • Minor variations which result in a separate distinct product require a Category 3 application under section 23.

  • In the context of a Category 3 application, a full assessment means that to grant the application the APVMA must undertake an assessment of the application that is equivalent to the following Schedule 7 modules — 1, 2.3, 3.3, 4, 5.1, 6.1, 7.1, 8.1, 11.1, and 12.

  • Category 3 applications and self-assessment notifications Any Category 3 application for approval of a change involving overseas manufactures or any self-assessment notification (SAN) of such a change must be accompanied by a current and relevant GMP clearance letter issued by the OMQ, in addition to any other supporting data required for the change.

  • They are thus both required to make a Category 3 application under the MMAR.

Related to Category 3 application

  • Mobile Application means a specialized software program downloaded onto a wireless communication device.

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

  • Uniform application means the current version of the national association of insurance commissioners uniform application for resident and nonresident insurance producer licensing.

  • Client Application means an application developed by Licensee 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.

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

  • Fee Application means an application for allowance and payment of a Fee Claim (including Claims for “substantial contribution” pursuant to section 503(b) of the Bankruptcy Code).

  • Initial application means the Application first provided to MFA on or before an Application Deadline to request an allocation of Tax Credits.

  • 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.

  • Planning Application means the application for [outline/full] planning permission dated [ ] bearing the Council’s reference number [ ];

  • L/C Application means an application and agreement for the issuance or amendment of a Letter of Credit in the form from time to time in use by the L/C Issuer.

  • 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.

  • Application packet means the information, documents, and fees required by the Department for the:

  • 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.

  • Date of application means the ef- fective date of an Application for Com- pensation filed with A.I.D. pursuant to§ 204.21 of this part.

  • Completed application means an application that satisfies all of the information and other requirements of the Tariff, including any required deposit.

  • 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.

  • 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)];

  • Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.

  • Customer Application means a software program in Object Code format that Customer has created and which integrates, in whole or in part, Value Added Technology, a Source Code Output File and/or a Binary Output File.

  • New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

  • 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.

  • Athlete Application means the form set by the NZOC that must be completed by any Athlete applying to be nominated and selected to the Games Team.

  • Database application form means the application form required by the Hibiscus Coast Municipality to be filled in by the successful tenderer, following the award of the contract, for inclusion on the HCM database before payment is made.

  • Renewal Application means a document used to collect pertinent data for renewal of permits

  • Application Package means the forms, schedules, checklists, exhibits, computer disks and instructions thereto obtained from the Agency, which shall be completed and submitted to the Agency in accordance with all regulations in order to apply for the HTC Program.

  • 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.