; or (ii) in the case of a biological product, a patent on the structure of the biological product. A patent shall be considered to be in effect for purposes of this subparagraph during any extension of the patent term under section 156 of title 35, United States Code. (B) Applicable period The term applicable period means, with respect to an applicable covered part D drug, any applicable patent described in subparagraph (A). (4) Condition of coverage (A) In general Subject to subparagraph (B), in order for coverage to be available under this part for an applicable covered part D drug (as defined in section 1860D–2(e)) of a manufacturer with respect to a plan year beginning on or after the date on which the applicable period with respect to such covered part D drug expires, the manufacturer must provide such applicable covered part D drug to PDP sponsors and MA organizations at the price negotiated under paragraph (1) or the price determined under paragraph (2), if applicable, for the plan year. (B) Authorizing coverage in certain circumstances Subparagraph (A) shall not apply to the dispensing of a covered part D drug if the Secretary has made a determination that the availability of the drug is essential to the health of beneficiaries under this part. . (b) Effective date The amendments made by this section shall apply to covered part D drugs dispensed on or after January 1, 2021. 3. Drug importation Chapter VIII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 et seq.) is amended by adding at the end the following: 810. Importation by individuals of prescription drugs from Canada (a) In general Notwithstanding any other provision of this Act, not later than 180 days after the date of enactment of this section, the Secretary shall promulgate regulations permitting individuals to safely import into the United States a prescription drug described in subsection (b). (b) Prescription drug A prescription drug described in this subsection— (1) is a prescription drug that— (A) is purchased from an approved