Page:United States Statutes at Large Volume 110 Part 2.djvu/463

 PUBLIC LAW 104-134—APR. 26, 1996 110 STAT. 1321-316 (ii) of subparagraph (A) if all of the following requirements are met in such country: "(i) Statutory or regulatory requirements which require the review of drugs and devices for safety and effectiveness by an entity of the government of such country and which authorize the approval of only those drugs and devices 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 and devices 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 and devices. "(ii) Statutory or regulatory requirements that the methods used in, and the facilities and controls used for— "(I) the manufacture, processing, and packing of drugs in the country are adequate to preserve their identity, quality, purity,, and strength; and "(II) the manufacture, preproduction design validation, packing, storage, and installation of a device are adequate to assure that the device will be safe and effective. "(iii) Statutory or regulatory requirements for the reporting of adverse reactions to drugs and devices and procedures to withdraw approval and remove drugs and devices found not to be safe or effective. "(iv) Statutory or regulatory requirements that the labeling and promotion of drugs and devices must be in accordance with the approval of the drug or device. "(v) The valid marketing authorization system in such country or countries is equivalent to the systems in the countries described in clauses (i) and (ii) of subparagraph (A). The Secretary shall not delegate the authority granted under this subparagraph. "(C) An appropriate country official, manufacturer, or exporter may request the Secretary to take action under subparagraph (B) to designate an additional country or countries to be added to the list of countries described in clauses (i) and (ii) of subparagraph (A) by submitting documentation to the Secretary in support of such designation. Any person other than a country requesting such designation shall include, along with the request, a letter from the country indicating the desire of such country to be designated. "(2) A drug described in subsection (a) may be directly exported to a country which is not listed in clause (i) or (ii) of paragraph (l)(A)if— "(A) the drug complies with the laws of that country and has valid marketing authorization by the responsible authority in that country; and "(B) the Secretary determines that all of the following requirements are met in that country: "(i) Statutory or regulatory 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

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