Page:United States Statutes at Large Volume 100 Part 5.djvu/271

 PUBLIC LAW 99-660—NOV. 14, 1986

100 STAT. 3745

country solely for the purpose of further export to a country listed in paragraph (4) in which the drug is approved. "(3)(A) Any person may apply to have a drug exported under paragraph (1). Such an application shall be filed at least 90 days before the date the applicant proposes to export the drug for which the application is submitted. Before the expiration of 10 days from the date of the submission of such an application, the Secretary shall publish a notice in the Federal Register which identifies the applicant under such application, the drug proposed to be exported under such application, and the country to which the drug is proposed to be exported. "(B) An application for the export of a drug shall— "(i) identify the drug to be exported, "(ii) list each country to which the drug is to be exported and list the persons in each such country to which the drug is to be exported, "(iii) contain a certification by the applicant that— "(I) the applicant will export the drug only to a country which is listed in paragraph (4) and in which the drug is approved unless the drug is authorized to be exported under paragraph (2) and will export only those quantities of the J drug which may reasonably be sold in each country to which it is to be exported, "(II) the drug is approved by each country to which it is to be exported unless the drug is authorized to be exported under paragraph (2) and the drug has not been withdrawn from sale in such country, "(III) the drug meets the requirements of paragraph (I)(D), "(IV) the drug will be labeled in accordance with paragraph (I)(E), and "(V) the drug meets the requirements of paragraphs (I)(C) and (IXG), "(iv) contain a certification by the holder of the exemption or authority for such drug described in paragraph (I)(A) that the holder will actively pursue the approval or licensing of the drug, "(v) identify the exemption or authority for an experimental drug product in effect for such drug under the laws referred to in paragraph (I)(A), "(vi) identify the establishments in which the drug is manufactured, and "(vii) include a written agreement from each importer to whom the drug is to be exported from the United States that such importer will not export the drug to a country which is not . listed under paragraph (4) and will provide notice to the applicant of any knowledge of an export of the drug to such a. country by any person and will maintain records of the drug wholesale distributors to which the drug is sold. "(C)(i) Before the expiration of 30 days after the date an application is submitted to the Secretary, the Secretary shall review the application to determine if the application meets the requirements of clauses (i), (ii), (iv), (v), (vi), and (vii) of subparagraph (B) and contains the certifications described in clauses (iii) (other than the certification required by clause (iiiXID) and (iv). If the Secretary determines that the application meets such requirements and contains such certifications the Secretary shall conditionally approve the application. An application which is so conditionally approved

Federal Register, publication.

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