Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).
Product Approval means the approval by any Approval Authority of the right to market or sell a Product.
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.
Examples of Product Approval in a sentence
See “Florida Product Approval Info Sheet” on the “Forms” page of the EH&S Building Code Enforcement website (xxx.xxx.xxx.xxx/xxxxxxxxx).
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 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 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 authorizations, permits and approvals that are issued by a Regulatory Authority and necessary for the use, distribution, promotion and/or sale of a Product in a particular country or jurisdiction, including pricing and reimbursement approval.
Product Approval means final FDA approval to market commercially the specified product for use by humans or animals.
Product Approval means the approval by MHLW of a registration of the Product that allows for the importation, marketing, promotion, distribution and sale of the Product in the Territory as medical devices for the treatment of Major Depressive Disorder indications that are substantially similar to the Major Depressive Disorder indications for which the Products are approved in the United States with substantially the same conditions as approved in the United States.