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The Children's Vaccine Initiative: Achieving the Vision
802(b)(A) of the Federal Food, Drug, and Cosmetic Act may, upon approval of an application meeting the requirements of subparagraph (B), be exported to a country listed under section 802(b)(4) of the Federal Food, Drug, and Cosmetic Act. The Secretary may not approve an application to export such a product unless the Secretary determines that the product is manufactured, processed, packaged, and held in conformity with current good manufacturing practice and the outside of the shipping package is labeled with the following statement: ''This product may be sold or offered for sale only in the following countries: ," the blank space being filled with a list of the countries to which export of the drug is authorized.
(B) An application for the export of a partially processed biological product shall—
(i) describe the partially processed biological product to be exported,
(ii) list each country to which the product is to be exported,
(iii) contain a certification by the applicant that the product will not be exported to a country not listed under clause (ii),
(iv) identify the establishments in which the product is manufactured, and
(v) contain a certification by the applicant that the final product to be developed from the partially processed product is approved in the country to which it is to be exported or approval of the final product is being sought in such country.
(2) A product described in paragraph (1) is not subject to licensure under this section.
(3) If the Secretary determines that prohibiting the export of a product described in paragraph (1) is necessary for protection of the public health in the United States or the country to which it is to be exported, the Secretary may not approve an application under paragraph (1) for the export of