Product Approval definition

Product Approval means, with respect to a Product, the approval of a Governmental Authority necessary for the marketing and sale of such Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

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Product Approval means the approval by any Approval Authority of the right to market or sell a Product.

Product Approval means the grant of all necessary regulatory and governmental approvals required to manufacture, use, store, import, export, transport and/or sell Licensed Products or Licensed Combination Products in any country of the Territory;

Examples of Product Approval 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.

• Licensee shall not make any modification to any Style for which NFLP has issued a Product Approval Form or depart from any applicable quality standards and specifications for any Style unless NFLP has approved such modification for such Style and issues a new Product Approval Form.

• Upon approval of the finished version of a sample Unit of a Style, NFLP shall execute a Product Approval Form that will contain any applicable quality standards and specifications.

• All Product Approval Forms are effective for one Fiscal Year only and Licensee must resubmit to NFLP each Style of each Licensed Product previously approved by NFLP for quality control approval each Fiscal Year.

• The aluminum windows and its components shall be installed in strict compliance with the Product Approval.

More Definitions of Product Approval

Product Approval means final FDA approval to market commercially in the U.S.A. the specified Product for use in humans.

Product Approval means, in relation to any particular jurisdiction, any and all approvals (excluding price and reimbursement approvals), licences, registrations, or authorisations of any country, federal, supranational, state, or local regulatory agency, department, bureau, or other government entity that are necessary for the manufacture, use, storage, import, transport, or sale of a Vaccine in such jurisdiction; provided however that Product Approval shall also mean approval by the competent authority in a given jurisdiction for a Vaccine to be sold without first being approved, e.g. for emergency stocking, defence or bio terror preparedness purposes, and similar, and irrespective of the clinical development stage reached for such Vaccine;

Product Approval means Application and/or Registration with any Product Approving Authorities for approval of Capacity and Capability Assessment (CCA), Schedule of Technical Requirements (STR), Scope of Work, Technical Specifications, Drawings, GA Drawings, Quality Assurance Plan (QAP), Consistency Test, Test Protocol, Type Test Report, Routine Test Report, Prototype Testing, Provisional Inspection Certificate, Field Trial, Performance Report, Final Inspection Certification, Maintenance and Operational Manual, Spare Parts Catalogue, Products Manual, or any modification(s) thereof or any other correspondence for products and/or services being manufactured or proposed to be manufactured.

Product Approval means all Regulatory Approvals material to, or legally required for, the development, testing (including the conduct of clinical trials), manufacturing, processing, distribution, marketing, storage, labeling, packaging, promotion, sale, offer for sale or use of any Products.

Product Approval means, with respect to a Product in any country or jurisdiction, all approvals (including where required, pricing and reimbursement approvals) necessary to market and sell such Product in such country or jurisdiction; provided that with respect to Europe, “Product Approval” means ********.

Product Approval means those regulatory or other approvals required for the manufacture, importation, promotion, pricing, marketing and sale of the Product in any particular country.

Product Approval means with respect to each Lithobid Product, the NDA set forth opposite the name of such Lithobid Product on Schedule I hereto, together with the Supplement.