Page:United States Statutes at Large Volume 100 Part 5.djvu/272

 100 STAT. 3746

PUBLIC LAW 99-660—NOV. 14, 1986

shall be finally approved within 5 days of the submission of the certification required by clause (iiiXII). "(ii) If the Secretary proposes to disapprove an application, the Secretary shall provide the applicant with a written statement specifying— "(I) the deficiencies which the applicant must correct in order to enable the Secretary to approve the application, and ' "(II) that the applicant has 60 days after receiving the statement to correct such deficiencies. "(D) If the holder of an application approved under subparagraph (C) for the export of a drug intends to export such drug to a country listed in paragraph (4) which is not listed in such application, such holder shall submit an amendment to such application to the Secretary not later than 30 days before the date of the proposed export to such country identifying the country to which the holder intends to export such drug and containing information sufficient to show that the drug is approved by such country and has not been withdrawn from sale in such country. The Secretary shall approve or disapprove the export of such drug to such country within 15 days of the receipt of the notice required by this subparagraph. Recipient "(4)(A) The countries to which a drug may be exported under countries. paragraph (1) are— "(i) Australia, ^ "(ii) Austria,

.ti.s "(iii) Belgium, '"(iv) Canada, "(vi) Federal Republic of Germany, i^"s: "(vii) Finland, "(viii) France, ' "(ix) Iceland, /. "(x) Ireland, ^ ^ "(xi)Italy, ' ' "(xii) Japan, ' ' '"'• "(xiii) Luxembourg, "(xiv) The Netherlands, "(xv) New Zealand, "(xvi) Norway, n "(xvii) Portugal, ., "(xviii) Spain, . » " ^ "(xix) Sweden,, '" *^ "(xx) Switzerlgmd, and "(xxi) The United Kingdom, "(B) Changes in the list contained in subparagraph (A) shall be based on the following criteria: Safety. "(i) Statutory or r ^ u l a to r y requirements which require the review of drugs for safety and effectiveness by an entity of the government of such country and which authorize the approval of only those drugs which have been determined to be safe and effective by experts employed by or acting on behalf of such entity and qualified by scientific training and experience to evaluate the safety and effectiveness of drugs on the basis of adequate and well-controlled investigations, including clinical investigations, conducted by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs.
 * ,''"(v) Denmark,

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