Type II Variation definition

Type II Variation means the supplemental application as defined and required by the EMA for significant changes to the manufacturing process described in the marketing authorization and which will be submitted to the EMA for the licensure of a manufacturing process at the applicable facility.
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Type II Variation means a variation of the type referred to in Article 3.1(b) of Regulation(EC) No. 541/95.
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Type II Variation shall have the definition as set forth in Commission Regulation (EC) No 1234/2008.
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Examples of Type II Variation in a sentence

  • Zogenix Submits Type II Variation Application to the European Medicines Agency (EMA) to Expand the Use of FINTEPLA® (Fenfluramine) for the Treatment of Seizures Associated with Lennox-Gastaut Syndrome.

  • For variations in the national procedure, the reference Member State should additionally receive the list of dispatch dates indicating the Type II Variation procedure number, the dates on which the applications have been sent to each Member State concerned and confirmation that the relevant fees have been paid as required by national competent authorities.

  • For variations in the national procedure, the reference Member State should additionally receive the list of dispatch dates indi­ cating the Type II Variation procedure number, the dates on which the applications have been sent to each Member State concerned and confirmation that the relevant fees have been paid as required by national competent authorities.

  • Rule 10b5-1 under the Exchange Act (“Rule 10b5-1”) provides a defense from insider trading liability under Rule 10b-5 under the Exchange Act (“Rule 10b-5”).

  • The title of the node- extension should identify the regulatory activity (e.g. Responses to Questions for the Initial Application, Responses to Questions for Type II Variation 028, etc.).

  • In the event that any European Union regulatory authority requires two (2) clinical trials for Approval in three (3) or more of the Major European Markets, then the Parties shall meet and negotiate in good faith a revised timeline for the Type II Variation filings.

  • A pressurised container and a spray pump are considered as specific pharmaceutical forms (“cutaneous spray, solution, pressurised container” and “cutaneous spray, solution, spray pump” are two pharmaceutical forms).A change or addition of pharmaceutical form results in an Extension Application except in case of a deletion of the solvent, which results in a Type II Variation.

  • In the event that any European Union regulatory authority requires two (2) clinical trials for Approval in three (3) or more of the Major European Markets, then the Parties shall meet and negotiate in good faith a revised timeline for the Type II Variation filings, including a revised timeframe for the Second Milestone Payment set forth in Section 5.5.

  • Also in October 2005, Abbott announced that it had simultaneously submitted a supplemental Biologics License Application (sBLA) with the US FDA and a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA as a treatment for ankylosing spondylitis, an inflammatory disease of the spine and spinal joints.

  • Clinical: In Europe: § ** ** § ** ** § ** ** § Successful EMA approval of a Type II Variation €2M § ** ** ** § ** ** § ** ** Each milestone payment is to be paid only one time regardless of how many times a Licensed Product achieves such milestone, and no payment is to be due for any milestone that is not achieved.

Related to Type II Variation

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

  • Coefficient of variation or “C” means the ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:

  • 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.

  • Minor Variations means any modifications reasonably required: (i) to comply with all applicable Legal Requirements and/or to obtain or to comply with any required permit (including the TI Permit); (ii) to comport with good design, engineering, and construction practices which are not material; or (iii) to make reasonable adjustments for field deviations or conditions encountered during the construction of the Tenant Improvements.

  • 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.

  • 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);

  • the Variation Agreement means the agreement a copy of which is set out in Schedule 2.

  • the First Variation Agreement means the agreement a copy of which is set out in Schedule 2.

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

  • Expiry Date (Data di Scadenza) means the Expiry Date as specified in § 1 of the Product and Underlying Data.

  • Variation means a change which is instructed by the Engineer/Employer under Sub-Clause 10.1.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Variation Procedure means the procedure for carrying out a Variation as set out in Clause 19.1 (Variation Procedure);

  • 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.

  • Flexographic printing means the application of words, designs, and pictures to a substrate by means of a roll printing technique in which the pattern to be applied is raised above the printing roll and the image carrier is made of rubber or other elastomeric materials.

  • Batch number means a unique numeric or alphanumeric identifier assigned prior to any testing to allow for inventory tracking and traceability.

  • frequency ride through as used herein shall mean the ability of a Small Generating Facility to stay connected to and synchronized with the system or equipment of the Transmission Owner and any Affected Systems during system disturbances within a range of under-frequency and over- frequency conditions, in accordance with Good Utility Practice and consistent with any standards and guidelines that are applied to other generating facilities in the Balancing Authority Area on a comparable basis. The term “voltage ride through” as used herein shall mean the ability of a Small Generating Facility to stay connected to and synchronized with the system or equipment of the Transmission Owner and any Affected Systems during system disturbances within a range of under-voltage and over-voltage conditions, in accordance with Good Utility Practice and consistent with any standards and guidelines that are applied to other generating facilities in the Balancing Authority Area on a comparable basis.

  • 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.

  • MI 61-101 means Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions;

  • NP 11-202 means National Policy 11-202 – Process for Prospectus Reviews in Multiple Jurisdictions;

  • Dietary supplement means a product, other than tobacco, that:

  • Variation Agreement means the agreement a copy of which is set out in Schedule 2;

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

  • 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.

  • Law 11/2015 means Law 11/2015 of 18 June, on recovery and resolution of credit institutions and investment firms (Ley 11/2015, de 18 de junio, de recuperación y resolución de entidades de crédito y empresas de servicios de inversión) as amended or replaced from time to time.