; or (B) is deemed under section 909(b) of the Food and Drug Administration Amendments Act of 2007 to have in effect an approved risk evaluation and mitigation strategy under section 505–1. (6) REMS impacting product distribution The term REMS impacting product distribution means a REMS that contains elements to assure safe use that impact the distribution of the product subject to the REMS. (b) Competitive access to covered products as a condition on approval or licensing As a condition of approval or licensure, or continuation or renewal of approval or licensure, of a covered product under section 505 of this Act or section 351 of the Public Health Service Act, respectively, the Secretary shall require that the covered product’s license holder not construe or apply any condition or restriction relating to the sale, resale, or distribution of the covered product, including any condition or restriction adopted, imposed, or enforced as an aspect of a risk evaluation and mitigation strategy, in a way that restricts or has the effect of restricting the supply of such covered product to an eligible product developer for development or testing purposes. (c) Competitive access for development purposes to products with REMS impacting product distribution With respect to a product subject to a REMS impacting product distribution, no aspect of such a REMS shall be construed or applied by the REMS product’s license holder in a way that prohibits or restricts the supply, at commercially reasonable, market-based prices, of such REMS product from the REMS product’s license holder to an eligible product developer with an applicable individual covered product authorization obtained pursuant to subsection (e) for development and testing purposes. (d) Single, shared system of elements To assure safe use Where an eligible product developer seeks approval of an application under 505(j) referencing a REMS product whose REMS includes elements to assure safe use— (1) no license holder shall take any step that impedes— (A) the prompt