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 shall have the definition as set forth in Commission Regulation (EC) No 1234/2008.
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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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Examples of Type II Variation in a sentence

  • Notifications are issued for type I variations and Article 61(3) notifications (unless part of a group including a type II variation or extension application or a worksharing application).

  • The new indication can be included either in the existing marketing authorisation via a type II variation or submitted with an application for a new marketing authorisation.

  • The applicants has made a commitment to submit a post-approval type II variation to harmonise the SmPC and package leaflet of the procedure according to the originator’s texts, which are currently under an Article 30 Referral procedure, once this is completed.

  • This Article shall not apply where a type II variation request is submitted in a grouping that includes an extension.

  • Article 20 of Commission Regulation (EC) No 1234/2008 of 24 November 2008 as amended by Commission Regulation (EU) No 712/2012 of 3 August 2012, sets-out the possibility for a marketing authorisation holder to submit the same type IB or type II variation, or the same group of variations affecting more than one marketing authorisations from the same holder in one application.

  • The MAH submitted a type II variation for Yasminelle, Belanette (Aliane), Liofora, Yasminelle 28, Belanette 28 (Aliane 28), Yasmin, Yasmin 28, Ethinylestradiol / Drospirenon 0,03 mg / 3 mg Berlipharm (Yira) and Palandra (ethinylestradiol, drospirenon) via the worksharing procedure.

  • III SCIENTIFIC DISCUSSION III.1 Clinical aspects The clinical documentation in support of this type II variation consisted of 1 Phase III parallel study (A21566) and 1 Phase III cross-over study (A07545).

  • Therefore, the MAH performed another bioequivalence study with the 150 mg prolonged release dose, as a post-approval commitment by means of a type II variation (NL/H/0539/002/II/002).

  • To resolve this issue, the MAH was requested to perform a new bioequivalence study without water to be submitted as a type II variation post-approval (see Annex I).

  • The size of the payment for a type IB variation is 100 euros and, for a type II variation, 383 euros per application.

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 comply with any request by Tenant for modifications to Landlord’s Work; (iii) to comport with good design, engineering, and construction practices that are not material; or (iv) to make reasonable adjustments for field deviations or conditions encountered during the construction of Landlord’s Work.

  • 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. [Section 3 amended by No. 3 of 1988 s. 5.]

  • 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;

  • the First Variation Agreement means the agreement a copy of which is set forth in the Second Schedule;

  • 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.

  • Electrostatic application means the application to a substrate of charged atomized paint droplets that are deposited by electrostatic attraction.

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

  • the Second Variation Agreement means the agreement a copy of which is set forth in the Third Schedule;

  • 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 16.1 (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.

  • Authorized nuclear pharmacist means a pharmacist who:

  • 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.

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

  • 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.

  • 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.