Variation Type II definition

Variation Type II means the authorisation by the Authorities of the “variation” of the Marketing Authorisation, which is necessary in order to include a new production site in the Marketing Authorisation and, thus, produce and market the Product(s) from such production site.
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Examples of Variation Type II in a sentence

  • The DUB part of the NDA was discussed in a Pre-NDA meeting with the FDA in February 2009 and this EU Variation Type II was discussed in a Pre-submission meeting with the MEB (2009).

  • Major Variation (Type II) Group Application.(3) The fee referred to in sub-paragraph (1)—(a) in connection with the first application considered by the licensing authority is the appropriate amount specified in this Part of this Schedule; and(b) in connection with each of the other applications is 50% of that amount.

  • Identical variations 46A Reduced fees for Type IB and Type II Applications, Minor Variation (Type IB) Group Applications and a Major Variation (Type II) Group Applications 47.

  • The license shall require that such statements be audited and published.

  • Major Variation (Type II) Extended Complex Group Application where—(i) the UK is a concerned member State£29,196(ii) the UK is the reference member State or the licensing authority is the reference authority for work sharing£40,804 Table 2 Fees for UK national variation applications Column 1 Kind of national variationColumn 2 Fee payable1.

  • EMA/352101/2017: EPAR - Assessment report – Variation Type II, 18 May 2017.

Related to Variation Type II

  • Variation Form means the form that will be completed and signed by the Parties to effect a Variation which shall be in the form set out in Framework Schedule 19 (Variation Form);

  • Variation Margin means, in connection with an outstanding futures contract owned or sold by the Corporation, the amount of cash or securities paid to or received from a broker (subsequent to the Initial Margin payment) from time to time as the price of such futures contract fluctuates.

  • Service Variation has the meaning attributed to it in paragraph 7.1;

  • Issue Type Category means, with respect to a Municipal Obligation acquired by the Fund, for purposes of calculating S&P Eligible Assets as of any Valuation Date, one of the following categories into which such Municipal Obligation falls based upon a good faith determination by the Fund: health care issues (including issues related to teaching and non-teaching hospitals, public or private); housing issues (including issues related to single- and multi-family housing projects); educational facilities issues (including issues related to public and private schools); student loan issues; transportation issues (including issues related to mass transit, airports and highways); industrial development bond issues (including issues related to pollution control facilities); public power utilities issues (including issues related to the provision of electricity, either singly or in combination with the provision of other utilities, and issues related only to the provision of gas); water and sewer utilities issues (including issues related to the provision of water and sewers as well as combination utilities not falling within the public power utilities category); special utilities issues (including issues related to resource recovery, solid waste and irrigation as well as other utility issues not falling within the public power and water and sewer utilities categories); general obligation issues; lease obligations (including certificates of participation); Escrowed Bonds; and other issues (“Other Issues”) not falling within one of the aforementioned categories. The general obligation issue category includes any issuer that is directly or indirectly guaranteed by the State or its political subdivisions. Utility issuers are included in the general obligation issue category if the issuer is directly or indirectly guaranteed by the State or its political subdivisions. Municipal obligations in the utility issuer category will be classified within one of the three following sub-categories: (i) electric, gas and combination issues (if the combination issue includes an electric issue); (ii) water and sewer utilities and combination issues (if the combination issues does not include an electric issue); and (iii) irrigation, resource recovery, solid waste and other utilities, provided that Municipal Obligations included in this sub-category (iii) must be rated by S&P in order to be included in S&P Eligible Assets. Municipal Obligations in the transportation issue category will be classified within one of the two following sub-categories: (i) streets and highways, toll roads, bridges and tunnels, airports and multi-purpose port authorities (multiple revenue streams generated by toll roads, airports, real estate, bridges); (ii) mass transit, parking seaports and others.

  • Prop Type Sr Lien: Orig Amount: P&&I: Cr. Score: Sevicer Loan Prod Code: Rem Term: Occp Code: Appr Value: Note Date: Debt Ratio: City Stat Zip Purpose: Curr Rate: CLTV: Prin Bal: Maturity Date: Lien Pos: 8740031 181 RFC01 $97,600.00 $24,400.00 $198.09 713 0301869988 7 181 1 $122,000.00 05/15/2003 42 CHANDLER AZ 85200 00 0.000 100 $24,400.00 06/01/2018 2 8728811 181 04 $56,755.00 $54,200.00 $514.84 735 0301861464 6 181 1 $112,000.00 05/15/2003 33 Gurnee IL 60000 00 0.000 100 $54,200.00 06/01/2018 2 8728637 181 14 $101,900.00 $25,475.00 $180.31 736 0301861845 7 181 1 $127,375.00 05/15/2003 31 CLINTON UT 84000 00 0.000 100 $25,475.00 06/01/2018 2 8718375 180 14 $136,800.00 $25,650.00 $235.60 720 0301856670 6 180 1 $171,000.00 05/15/2003 44 WENATCHEE WA 98800 00 0.000 95 $25,650.00 05/19/2018 2 8370728 181 14 $376,000.00 $47,000.00 $412.01 786 0301870333 6 181 1 $470,000.00 05/15/2003 42 Tonwship of West Windsor NJ 00000 00 0.000 90 $47,000.00 06/01/2018 2 8370488 181 09 $353,600.00 $66,300.00 $477.27 758 0301869814 7 181 1 $442,000.00 05/15/2003 34 Centreville VA 20100 00 0.000 95 $66,300.00 06/01/2018 2 8720207 181 14 $220,000.00 $65,000.00 $450.05 791 0301867941 7 181 1 $305,000.00 05/15/2003 35 Township Of Roxbury NJ 00000 00 0.000 94 $65,000.00 06/01/2018 2 8370724 181 04 $344,000.00 $64,500.00 $464.32 688 0301870432 7 181 1 $430,000.00 05/15/2003 31 Washington DC 20000 00 0.000 95 $64,500.00 06/01/2018 2 8728733 181 14 $169,004.00 $46,000.00 $450.29 691 0301861373 6 181 1 $220,000.00 05/15/2003 43 Moore OK 73100 00 0.000 98 $46,000.00 06/01/2018 2 8740067 181 09 $296,000.00 $74,000.00 $750.56 698 0301870580 6 181 1 $370,000.00 05/16/2003 42 TEMECULA CA 92500 00 0.000 100 $74,000.00 06/01/2018 2 8728667 181 14 $164,000.00 $14,450.00 $128.87 788 0301862496 6 181 1 $205,000.00 05/16/2003 44 CHELSEA AL 35000 00 0.000 88 $14,450.00 06/01/2018 2 8715337 181 09 $129,600.00 $32,400.00 $347.97 673 0301853537 6 181 1 $162,000.00 05/16/2003 43 RICHMOND TX 77400 00 0.000 100 $32,400.00 06/01/2018 2 8715329 181 14 $108,000.00 $13,500.00 $144.99 798 0301853412 6 181 1 $135,000.00 05/16/2003 50 NORTH RICHLAND HILLS TX 00000 00 0.000 90 $13,500.00 06/01/2018 2 8715331 181 14 $144,000.00 $18,000.00 $120.97 713 0301853420 7 181 1 $180,000.00 05/16/2003 23 BATON ROUGE LA 70800 00 0.000 90 $18,000.00 06/01/2018 2 8370636 181 04 $194,400.00 $24,300.00 $178.14 769 0301867180 7 181 1 $243,000.00 05/16/2003 24 Alexandria VA 22300 00 0.000 90 $24,300.00 06/01/2018 2 8727175 180 14 $51,700.00 $24,300.00 $225.13 778 0301861613 6 180 1 $82,000.00 05/16/2003 28 Ft. Wayne IN 46808 00 7.490 93 $24,300.00 05/21/2018 2 8715339 180 14 $262,400.00 $65,600.00 $458.68 734 0301851549 7 180 1 $328,000.00 05/16/2003 36 BELLINGHAM WA 98200 00 0.000 100 $65,600.00 05/16/2018 2 8728653 180 14 $237,371.00 $21,000.00 $167.09 640 0301862116 7 180 1 $300,000.00 05/16/2003 49 CANAL WINCHESTER OH 00000 00 0.000 87 $21,000.00 05/21/2018 2 8715301 181 14 $250,000.00 $47,500.00 $331.31 778 0301852554 7 181 1 $350,000.00 05/16/2003 50 WESTMINSTER MD 21100 00 0.000 85 $47,500.00 06/01/2018 2 8370722 300 14 $85,979.00 $44,200.00 $403.83 669 0301867537 8 300 1 $144,000.00 05/16/2003 45 Ypsilanti MI 48100 00 00.000 91 $44,200.00 05/22/2028 2 8724285 181 09 $235,200.00 $29,400.00 $200.06 710 0301859153 7 181 1 $294,000.00 05/16/2003 30 CARSON CITY NV 89700 00 0.000 90 $29,400.00 06/01/2018 2

  • variation date means the date on which clause 4 of the variation agreement made on or about 17 November 2010 between the State and the Company comes into operation;

  • Open type traction battery means a type of battery requiring liquid and generating hydrogen gas released to the atmosphere.

  • Variation Procedure means the procedure set out in Clause 22.1 (Variation Procedure);

  • Participating Prescription Drug Provider means an independent retail Pharmacy, chain of retail Pharmacies, mail-order Pharmacy or specialty drug Pharmacy which has entered into an agreement to provide pharmaceutical services to participants in the benefit program. A retail Participating Pharmacy may or may not be a select Participating Pharmacy as that term is used in the Vaccinations Obtained Through Participating Pharmacies section.

  • Categorical pretreatment standard or "categorical standard" means any regulation containing pollutant discharge limits promulgated by the environmental protection agency in accordance with sections 307(b) and (c) of the Act (33 U.S.C. section 1317) that apply to a specific category of users and that appear in 40 CFR chapter I, subchapter N, parts 405 through 471.

  • Multiple Bill/Single Tariff means the billing method used when Switched Exchange Access Services is jointly provided by the Parties. As described in the MECAB document, each Party will render a bill in accordance with its own tariff for that portion of the service it provides. Each Party will bill its own network access service rates.

  • Multiple Bill/Single Tariff means the billing method used when Switched Exchange Access Services is jointly provided by the Parties. As described in the MECAB document, each Party will render a bill in accordance with its own tariff for that portion of the service it provides. Each Party will bill its own network access service rates.

  • Brand Name or Equal Specification means a specification which uses one or more manufacturer’s names or catalogue numbers to describe the standard of quality, performance, and other characteristics needed to meet District requirements, and which provides for the submission of equivalent products.

  • Basic Comprehensive User Guide means the Ministry document titled Basic Comprehensive Certificates of Approval (Air) User Guide” dated April 2004 as amended.

  • Basic health plan model plan means a health plan as required in RCW 70.47.060(2)(e).

  • Service Type means the customer class, partial customer class and/or group of customer classes, as set forth in a Transaction Confirmation.

  • Terms of Reference (TORs) means the Terms of Reference that explains the objectives, scope of work, activities, and tasks to be performed, respective responsibilities of the Procuring Entity and the Consultant, and expected results and deliverables of the assignment.

  • Data Universal Number System (DUNS) Number means the 9-digit number assigned by Dun and Bradstreet, Inc. (D&B) to identify unique business entities.

  • Attachment point means a point on the network at which network assets are connected to assets owned by another person.

  • Instantaneous flow measurement means the flow measured during the minimum time required for the flow-measuring device or method to produce a result in that instance. To the extent practical, instantaneous flow measurements coincide with the collection of any grab samples required for the same sampling period so that together the samples and flow are representative of the discharge during that sampling period.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • COVID-19 Measures means any quarantine, “shelter in place,” “stay at home,” workforce reduction, social distancing, shut down, closure, sequester or any other Law, directive, guidelines or recommendations by any Governmental Authority (including the Centers for Disease Control and the World Health Organization) in each case in connection with, related to or in response to COVID-19, including the Coronavirus Aid, Relief, and Economic Security Act (CARES) or any changes thereto.

  • Terms of Reference (TOR) means the document included in the RFP as Section 5 which explains the objectives, scope of work, activities, tasks to be performed, respective responsibilities of the Client and the Consultant, and expected results and deliverables of the Assignment/job.

  • engine type means a category of engines which do not differ in essential engine characteristics.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Functional Specifications means the descriptions of features and functions of the Application as expressly set forth in Quote.