Product Approval definition

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

• Provide the permit application date OR FBC/MDC Product Approval number OR Year of Original Installation/Replacement OR indicate that no information was available to verify compliance for each roof covering identified.

• 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.

• Commissioner Stone presented the Product Approval Oversight Committee’s recommendations for entities and product approvals on the consent agenda for approval, and Jeff Blair presented the recommendations for product approvals with comments and/or discussion.

• All roof coverings listed above meet the FBC with a FBC or Miami-Dade Product Approval listing current at time of installation OR have a roofing permit application date on or after 3/1/02 OR the roof is original and built in 2004 or later.□ B.

• As required to manage the City’s energy commodity risk the ERMC shall approve new products provided the requirements of the New Product Approval Procedure are met.

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, with respect to a Licensed Product in a country in the Territory, Regulatory Approval for such Licensed Product in such country, excluding any required pricing or reimbursement approval in such country for such Licensed Product.

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 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.

Product Approval means final FDA approval to market commercially the specified product for use by humans or animals.