Product Filing definition

Product Filing means a Product, Rate or Advertisement submitted to the Commission for review in accordance with the Commission’s Rules and Operating Procedures.
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Product Filing means a Product, Rate or Advertisement submitted to the IIPRC for review in accordance with the IIPRC’s Rules and Operating Procedures.
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Product Filing means a filing submitted to the Commission for approval of a product, rate or advertisement in accordance with one or more uniform standards.
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Examples of Product Filing in a sentence

  • No material deficiencies have been asserted by any applicable Government Entity with respect to any Product Approval or Product Filing, nor, to the Seller’s knowledge, are there any facts or circumstances that would be likely to lead to such assertions being made.

  • Within two (2) business days after Closing, Seller shall deliver to Purchaser and the FDA, with respect to each Product Filing, (i) an executed letter of “Transfer of Ownership of NDA” substantially in the form set forth in Exhibit F and (ii) confirmation of Seller’s submission of such letter to the FDA and the date of such submission.

  • If any Product Filing is required in the Territory as a result of such change of CMOs or any change of any facility of its existing CMOs, Verrica shall take into account the time required for such Product Filing to be approved by the applicable Regulatory Authority in the Territory when implementing such change.

  • For the purposes of this Agreement, each Product Approval Transfer or Product Filing Transfer (as applicable) shall occur on the date on which the relevant Product Approval Transfer or Product Filing Transfer (as applicable) becomes effective (such date being the relevant “Product Approval Transfer Date” or the “Product Filing Transfer Date” (as applicable)).

  • Until the last Product Filing Transfer Date on a jurisdiction-by-jurisdiction basis, the Buyer shall not submit any Product Approval Documentation or Product Filing Documentation (as applicable) to a Governmental Authority without the prior approval of the Seller, such approval not to be unreasonably withheld or delayed.

  • Except as specifically required under this Agreement or the Transition Services Agreement, the Seller shall not (and shall procure that the relevant Product Approval Holder or Product Filing Holder shall not) make any amendments or variations of any Product Approval or Product Filing without the Buyer’s prior written consent.

  • Each party shall cooperate with and provide all reasonable assistance and information required by the other party to prepare, or cause the preparation of, the Product Approval Documentation and the Product Filing Documentation.

  • The Seller shall not submit any Product Approval Documentation or Product Filing Documentation (as applicable) to a Governmental Authority without the prior approval of the Buyer, such approval not to be unreasonably withheld or delayed.

  • From the date that the Product Filing Delegation is effective (“Product Filing Delegation Effective Date”) until the date of the Product Filing Transfer in each such jurisdiction, Seller shall remain the legally designated Product Filing Holder and Buyer shall, to the extent permitted by applicable Law, conduct, at its sole cost, all activities of the Product Filing Holder.

  • Notwithstanding the foregoing, where any Product Approval Documentation or Product Filing Documentation is required by applicable Law or any Regulatory Authority to be prepared and submitted by the Seller, the Product Approval Holder or the Product Filing Holder, the Seller shall be responsible for preparing and submitting, or shall cause the relevant Product Approval Holder or Product Filing Holder to prepare and submit, such Product Approval Documentation or Product Filing Documentation.


More Definitions of Product Filing

Product Filing means a Product, Rate or Advertisment submitted to the Commission for review in accordance with the Commission’s Rules and Operating Procedures.
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Product Filing means a filing submitted by an Insurer to the Commission for approval of a Rate, Product or Advertisement.
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Related to Product Filing

  • RoC Filing means the date on which the Prospectus is filed with the RoC and dated in terms of Section 32(4) of the Companies Act, 2013;

  • Regulatory Filing means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to any compound or product (including any Licensed Compound or Licensed Product), or its use or potential use in humans, including any documents submitted to any Regulatory Authority and all supporting data, including INDs and NDAs, and all correspondence with any Regulatory Authority with respect to such compound or product (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority).

  • Regulatory Filings means all applications, approvals, licenses, notifications, registrations, submissions and authorizations made to or received from a Regulatory Authority in the Territory necessary for the development, manufacture or commercialization of a pharmaceutical product, including any INDs, NDAs and Regulatory Approvals.

  • Regulatory Materials means regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals or other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop, Manufacture, or Commercialize a Licensed Product in a particular country or jurisdiction.

  • Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.