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 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;

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

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.

• UL Listed, FM Approved, Dade County Product Approval, Florida Building Code Approved.

• All roof coverings have a Miami-Dade Product Approval listing current at time of installation OR (for the HVHZ only) a roofing permit application after 9/1/1994 and before 3/1/2002 OR the roof is original and built in 1997 or later.

• Use ‘Equal Product Approval Request Form’ to request approval of equal products, manufacturers, or suppliers before bidding or before installation, as noted in individual Sections.

• Miami-Dade NOA or Florida Product Approval referenced in the product approval form.

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 the approval by FDA of the NDA with respect to the Product.

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 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.

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.

Product Approval means, with respect to a Product, the final and unconditional approval of an ANDA by the FDA enabling Genpharm or the Manufacturer to sell such Product in the Territory;