Reimbursement Approval definition

Reimbursement Approval means an approval, agreement, determination, or other decision by the applicable Governmental Authority that establishes prices charged to end-users for pharmaceutical or biologic products at which a particular pharmaceutical or biologic product will be reimbursed by the Regulatory Authorities or other applicable Governmental Authorities in the Territory.
Reimbursement Approval means the approval, agreement, determination or decision recommending or approving the Product for use and/or establishing the prices for the Product that can be reimbursed in regulatory jurisdictions where the applicable Governmental Authority or Non-Governmental Authority approves, determines or recommends the reimbursement or use of pharmaceutical products.
Reimbursement Approval means, with respect to a Product in the Territory, any pricing reimbursement registration or listing on formularies and all approval necessary to an optimal introduction of the Product on the market.

Examples of Reimbursement Approval in a sentence

  • The responsible Party also shall immediately notify the other Party if it receives any written notice that a Regulatory Authority is limiting, suspending or revoking any Regulatory Approval or Pricing and Reimbursement Approval.


More Definitions of Reimbursement Approval

Reimbursement Approval means the official decision by the relevant Governmental Entity in any Jurisdiction responsible for establishing a reimbursement scheme to cover the costs related to the treatment of patients with the Product.
Reimbursement Approval means, with respect to a Licensed Product, the receipt by Genzyme or a Related Party of Genzyme of authorization for reimbursement of or funding of such Licensed Product in the national health service or insurance from the national-level Governmental Authority responsible for authorizing reimbursement for or determining pricing for, pharmaceutical products in such country or national regulatory jurisdiction.
Reimbursement Approval means such governmental and other approvals in the Territory for a buyer to claim reimbursement at any level for the purchase of the Products from private or public health organizations, including all pricing approvals.
Reimbursement Approval means with respect to a particular country or regulatory jurisdiction, any pricing and reimbursement approvals of the applicable Regulatory Authority or other Governmental Authority in such country or regulatory jurisdiction for a product for treatment, prevention, palliation and cure of human diseases or conditions in such country or regulatory jurisdiction at the relevant time.
Reimbursement Approval means with respect to a particular Licensed Product and a particular country or regulatory jurisdiction, [***].
Reimbursement Approval shall have the meaning specified in Section 12.4.
Reimbursement Approval means, with respect to a particular Product in the Field in a particular country in the Territory, such governmental approval as may be required, if any, for price and/or reimbursement approval of such Product in the Field in such country;