CTD Format definition

CTD Format means the format of a common technical document recommended by ICH or adopted by any Governmental Authority in the Territory responsible for marketing authorization or monitoring the marketing of the Product that are formatting requirements or methods for the submission of other or supplemental information or data to such Government Authority and as may be updated from time to time.
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CTD Format has the meaning set forth in Section 3.4.
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CTD Format means the format of a common technical document recommended by ICH from time to time.
Sample 1

Examples of CTD Format in a sentence

  • Within [***] days after the Effective Date, Lubrizol will deliver to Braeburn the full Module 3 Information (restricted and unrestricted) for the Product intended for use in the Risperidone IDDS Product in CTD Format (the “Module 3 Information”).

  • REMARKS ORDERED PRINTED Representative Collier moved to print all remarks on CSHB 20.

  • The approved SmPC from SDRA should then be supplied to National Drug Authority as they become available.For more guidance refer to NDA Guidelines on Submission of Documentation for Registration of a Pharmaceutical Product for Human Use (CTD Format Guidelines) Format and Content of Summary of Products Characteristics for guidance on preparation of SmPC (Doc.No.PAR/GDL/004).

  • Product should be labeled as prescribed in the NDA Guidelines on Submission of Documentation for Registration of a Pharmaceutical Product for Human Use (CTD Format Guidelines) on container labeling for guidance on preparation of product labeling (Doc.

  • Furthermore, please keep in mind: Most private housing companies do not offer short renting terms.

  • The primary affected parties in Eversource’s Massachusetts territories are: ISO-New England, National Grid, Until and various municipalities.

  • God manifests himself in him” said Vanier, standing just a few feet from John Paul II, who never took his eyes off Vanier’s.

Related to CTD Format

  • Maintenance Manual shall have the meaning ascribed to it in Clause 10.7; “Maintenance Programme” shall have the meaning set forth in Clause 14.3; “Maintenance Period” shall have the meaning set forth in Clause 14.1; “Maintenance Requirements” shall have the meaning set forth in Clause14.2;

  • Format C: Format for the Bidder (Single Firm / Partner(s) in case of Joint Venture) for technical experience in compliance to para 1.01 (III) {(i) or (ii) or (iii)} of Annexure-A to BDS (Volume-I : Section-III) [In case of Joint Venture bidder, the QR data of each of the partner (in support of meeting the requirement of para 1.01 (III) (iv) of Annexure-A to BDS (Volume-I : Section-III)] is also is to furnished, as applicable, using this format. The bidder (Single Firm / Partner(s) in case of Joint Venture) who is willing to qualify in compliance to para 1.01 (III) {(ii) or (iii)} above shall fill below format for two or all three contracts.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • 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.

  • Transparency Reports means a report in accordance with Schedule 7 Part 1 (Transparency Reports) containing the contract information as set out in the table for that Part for publication by the Authority in the interests of transparency.

  • machine-readable format means a file format structured so that software applications can easily identify, recognize and extract specific data, including individual statements of fact, and their internal structure;

  • Facsimile (FAX) prescription means a written prescription or order that is transmitted by an electronic device over telephone lines that sends the exact image to the receiving pharmacy in hard copy form.

  • User Manual means the user guide, Help guide, and other documentation provided with the software, updated agreements provided on the website of Quick Heal (xxx.xxxxxxxxx.xxx), explanatory or other materials as provided from time to time by Quick Heal.

  • Electronic prescription means a written prescription that is generated on an electronic application and is transmitted to a pharmacy as an electronic data file; Schedules II through V prescriptions shall be transmitted in accordance with 21 CFR Part 1300.

  • Prescription monitoring program “PMP,” or “program” means the program established pursuant to 657—Chapter 37 for the collection and maintenance of PMP information and for the provision of PMP information to authorized individuals.

  • XXXXX-Compatible Format Any format compatible with XXXXX, including HTML, Word, Excel or clean, searchable PDFs.

  • Database Management System (DBMS) A system of manual procedures and computer programs used to create, store and update the data required to provide Selective Routing and/or Automatic Location Identification for 911 systems. Day: A calendar day unless otherwise specified. Dedicated Transport: UNE transmission path between one of CenturyLink’s Wire Centers or switches and another of CenturyLink’s Wire Centers or switches within the same LATA and State that are dedicated to a particular customer or carrier. Default: A Party’s violation of any material term or condition of the Agreement, or refusal or failure in any material respect to properly perform its obligations under this Agreement, including the failure to make any undisputed payment when due. A Party shall also be deemed in Default upon such Party’s insolvency or the initiation of bankruptcy or receivership proceedings by or against the Party or the failure to obtain or maintain any certification(s) or authorization(s) from the Commission which are necessary or appropriate for a Party to exchange traffic or order any service, facility or arrangement under this Agreement, or notice from the Party that it has ceased doing business in this State or receipt of publicly available information that signifies the Party is no longer doing business in this State.

  • DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

  • accessible format copy means a copy of a work in an alternative manner or form which gives a beneficiary person access to the work, including to permit the person to have access as feasibly and comfortably as a person without visual impairment or other print disability. The accessible format copy is used exclusively by beneficiary persons and it must respect the integrity of the original work, taking due consideration of the changes needed to make the work accessible in the alternative format and of the accessibility needs of the beneficiary persons;

  • Subsystem means any subset of the System identified as such in the Contract that may be supplied, installed, tested, and commissioned individually before Commissioning of the entire System.

  • Master File has the meaning set forth in the CAISO Tariff.

  • MI Reporting Template means the form of report set out in the Annex to Framework Schedule 8 (Management Information) setting out the information the Supplier is required to supply to the Authority;

  • Design Criteria Package means concise, performance-oriented drawings or specifications for a public construction project. The purpose of the Design Criteria Package is to furnish sufficient information to permit Design-Build Firms to prepare a bid or a response to the District’s Request for Proposals, or to permit the District to enter into a negotiated Design- Build Contract. The Design Criteria Package must specify performance- based criteria for the public construction project, including the legal description of the site, survey information concerning the site, interior space requirements, material quality standards, schematic layouts and conceptual design criteria of the project, cost or budget estimates, design and construction schedules, site development requirements, provisions for utilities, stormwater retention and disposal, and parking requirements applicable to the project. Design Criteria Packages shall require firms to submit information regarding the qualifications, availability, and past work of the firms, including the partners and members thereof.

  • Electronic nicotine delivery system or “(ENDS)” means any device that delivers a vaporized solution (including nicotine, THC, or any other substance) by means of cartridge or other chemical delivery systems. Such definition shall include, but may not be limited to, any electronic cigarette, vape pen, hookah pen, cigar, cigarillo, pipe, or personal vaporizer. ENDS are not FDA-approved nicotine replacement therapy devices.

  • Type B package means a Type B packaging together with its radioactive contents. On approval, a Type B package design is designated by NRC as B(U) unless the package has a maximum normal operating pressure of more than 700 kPa (100 lb/in2 ) gauge or pressure relief device that will allow the release of radioactive material to the environment under the tests specified in 10 CFR 71 (hypothetical accident conditions), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see DOT regulations in 49 CFR 173. A Type B package approved before September 6, 1983, was designated only as Type B. Limitations on its use are specified in 10 CFR 71.13.

  • Electronic Subcontracting Reporting System (eSRS) means the Governmentwide, electronic, web-based system for small business subcontracting program reporting. The eSRS is located at http://www.esrs.gov.

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

  • layout plan means a plan of the project depicting the division or proposed division of land into plots, roads, open spaces, amenities, etc. and other details as may be necessary;

  • Prescription drug order means an original or new order from a practitioner for drugs, drug-related devices or treatment for a human or animal, including orders issued through collaborative care agreements. Lawful prescriptions result from a valid practitioner-patient relationship, are intended to address a legitimate medical need, and fall within the prescribing practitioner's scope of professional practice;

  • Protocol Number 1002-048 Protocol Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with Elevated LDL-C Protocol Date: 18 January 2017 Sponsor: Esperion Therapeutics, Inc. Country where Institution is Conducting Study Czech Republic Location where the study will be conducted: Kardiologická ambulance, which is a division/part of the Institution Key Enrollment Date: 100 Calendar Days after Site Initiation Visit (being the date by which Site must enrol at least one (1) subject as more specifically set out in section 1.7 “Key Enrollment Date” below) ECMT / EC / RA ECMT: Ethics Committee Fakultni nemocnice v Motole V Uvalu 84 150 06 Xxxxx 0 Xxxxx Xxxxxxxx; Mgr. xxxxxxxxxxxxx Etická komise Nemocnice Havlíčkův Brod Husova 2624 580 22 Havlíčkův Brod RA: State Institute for Drug Control, Xxxxxxxxx 00, 000 00 Xxxxx 00 Xxxxx Xxxxxxxx Investigator name, (the “Investigator”) xxxxxxxxxxxxx Číslo Protokolu: 1002-048 Název Protokolu: Randomizované, dvojitě zaslepené, placebem kontrolované multicentrické klinické hodnocení, s paralelními skupinami, posuzující účinnost a bezpečnost kyseliny bempedové (ETC 1002) 180 mg denně jako doplňku k léčbě ezetimibem u pacientů se zvýšenou hladinou LDL-C Datum Protokolu: 18. 1. 2017 Zadavatel: Esperion Therapeutics, Inc. Stát, ve kterém má sídlo Zdravotnické zařízení, které provádí Studii Česká republika Místo, kde bude prováděna Studie: Kardiologická ambulance, která je součástí/oddělením Zdravotnického zařízení Klíčové datum zařazení: 100 kalendářních dnů po Iniciační návštěvě Místa provádění klinického hodnocení (a to jakožto den, ke kterému je Místo provádění klinického hodnocení povinno zařadit minimálně jeden (1) subjekt, jak je dále podrobněji rozvedeno níže v odstavci 1.7 “Klíčové datum zařazení”) MEK / EK / SÚKL MEK: Etická komise Fakultní nemocnice v Motole V Úvalu 84 150 06 Xxxxx 0 Xxxxx xxxxxxxxx; xxxxxxxxxxxxx Etická komise Nemocnice Havlíčkův Brod Husova 2624 580 22 Havlíčkův Brod SÚKL: Státní ústav pro kontrolu léčiv, Šrobárova 48, 100 41 Xxxxx 00 Xxxxx xxxxxxxxx Jméno zkoušejícího, ( “Zkoušející”) xxxxxxxxxxxxx The following additional definitions shall apply to this Agreement: Ve Smlouvě jsou použity následující smluvní definice:

  • Data Universal Numbering System +4 (DUNS+4) number means the DUNS number assigned by D&B plus a 4- character suffix that may be assigned by a business concern. (D&B has no affiliation with this 4-character suffix.) This 4-character suffix may be assigned at the discretion of the business concern to establish additional SAM records for identifying alternative Electronic Funds Transfer (EFT) accounts for the same parent concern.