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る医療機器等審査等に係る医療機器及び体外診断用医薬品の範囲）"]},{"tag":"ArticleTitle","attr":{},"children":["第三十七条の三十"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["次に掲げる場合における法第二十三条の二の七第一項（法第二十三条の二の十七第五項及び第六項において準用する場合を含む。以下この条において同じ。）の政令で定める医療機器（専ら動物のために使用されることが目的とされているものを除く。）又は体外診断用医薬品（専ら動物のために使用されることが目的とされているものを除く。）は、法第二十三条の二の五第一項に規定する医療機器（専ら動物のために使用されることが目的とされているものを除く。）又は体外診断用医薬品（専ら動物のために使用されることが目的とされているものを除く。）とする。"]}]},{"tag":"Item","attr":{"Num":"1"},"children":[{"tag":"ItemTitle","attr":{},"children":["一"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["法第二十三条の二の七第一項の規定により機構に法第二十三条の二の五第一項若しくは第十三項（法第二十三条の二の十七第五項において準用する場合を含む。）又は第二十三条の二の十七第一項の承認のための審査及び法第二十三条の二の五第五項（同条第十三項（法第二十三条の二の十七第五項において準用する場合を含む。）及び法第二十三条の二の十七第五項において準用する場合を含む。）、第二十三条の二の六の二第三項（法第二十三条の二の十七第五項において準用する場合を含む。）又は第二十三条の二の六の三第二項（法第二十三条の二の五第三項前段に規定する資料についての調査に係る部分に限り、法第二十三条の二の八第二項（法第二十三条の二の二十第一項において準用する場合を含む。）及び第二十三条の二の十七第五項において準用する場合を含む。）の規定による調査を行わせる場合"]}]}]},{"tag":"Item","attr":{"Num":"2"},"children":[{"tag":"ItemTitle","attr":{},"children":["二"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["法第二十三条の二の七第一項の規定により機構に法第二十三条の二の五第六項若しくは第八項（これらの規定を同条第十三項（法第二十三条の二の十七第五項において準用する場合を含む。）及び法第二十三条の二の十七第五項において準用する場合を含む。）又は第二十三条の二の六の三第二項（医療機器又は体外診断用医薬品の製造管理又は品質管理の方法についての調査に係る部分に限り、法第二十三条の二の八第二項（法第二十三条の二の二十第一項において準用する場合を含む。）及び第二十三条の二の十七第五項において準用する場合を含む。）の規定による調査並びに法第二十三条の二の六第一項の規定による基準適合証の交付及び同条第三項の規定による基準適合証の返還の受付を行わせる場合"]}]}]}]}]},{"tag":"Article","attr":{"Num":"37_31"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（特例承認を受けた者に義務として課することができる措置）"]},{"tag":"ArticleTitle","attr":{},"children":["第三十七条の三十一"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["法第二十三条の二の八第三項（法第二十三条の二の二十第一項において準用する場合を含む。）の政令で定める措置は、次に掲げる措置とする。"]}]},{"tag":"Item","attr":{"Num":"1"},"children":[{"tag":"ItemTitle","attr":{},"children":["一"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["当該品目の品質、有効性及び安全性に関する調査として厚生労働省令で定める調査を行い、その結果を厚生労働大臣に報告する措置"]}]}]},{"tag":"Item","attr":{"Num":"2"},"children":[{"tag":"ItemTitle","attr":{},"children":["二"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["当該品目の使用によるものと疑われる疾病、障害又は死亡の発生を知つたときは、速やかに、その旨を厚生労働大臣に報告する措置"]}]}]},{"tag":"Item","attr":{"Num":"3"},"children":[{"tag":"ItemTitle","attr":{},"children":["三"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["当該品目が法第二十三条の二の八第一項（法第二十三条の二の二十第一項において準用する場合を含む。）の規定による法第二十三条の二の五又は第二十三条の二の十七の承認を受けている旨が当該医療機器又は体外診断用医薬品を一般に購入し、又は使用する者に説明され、かつ、理解されるために必要な措置"]}]}]},{"tag":"Item","attr":{"Num":"4"},"children":[{"tag":"ItemTitle","attr":{},"children":["四"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["前三号に掲げる措置のほか、当該品目の販売又は授与の相手方及びこれらの相手方ごとの販売数量又は授与数量を厚生労働大臣に報告する措置その他の保健衛生上の危害の発生又は拡大を防止するために必要な措置として厚生労働省令で定める措置"]}]}]}]}]},{"tag":"Article","attr":{"Num":"37_32"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（機構による使用成績評価の確認等に係る医療機器及び体外診断用医薬品の範囲）"]},{"tag":"ArticleTitle","attr":{},"children":["第三十七条の三十二"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["法第二十三条の二の十第一項（法第二十三条の二の十九において準用する場合を含む。）の政令で定める医療機器（専ら動物のために使用されることが目的とされているものを除く。）又は体外診断用医薬品（専ら動物のために使用されることが目的とされているものを除く。）は、法第二十三条の二の九第一項（法第二十三条の二の十九において準用する場合を含む。）に規定する医療機器（専ら動物のために使用されることが目的とされているものを除く。）又は体外診断用医薬品（専ら動物のために使用されることが目的とされているものを除く。）とする。"]}]}]}]},{"tag":"Article","attr":{"Num":"37_33"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（機構による使用成績評価の確認等の実施に関する技術的読替え）"]},{"tag":"ArticleTitle","attr":{},"children":["第三十七条の三十三"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["法第二十三条の二の十第一項（法第二十三条の二の十九において準用する場合を含む。）の規定による技術的読替えは、次の表のとおりとする。"]}]},{"tag":"TableStruct","attr":{},"children":[{"tag":"Table","attr":{"WritingMode":"vertical"},"children":[{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["法の規定中読み替える規定"]}]},{"tag":"TableColumn","attr":{"Bor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{"tag":"Paragraph","attr":{"Num":"3"},"children":[{"tag":"ParagraphNum","attr":{},"children":["３"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["薬局製造販売医薬品の製造販売に係る法第十二条第一項の許可は、厚生労働大臣が薬局ごとに与える。"]}]}]},{"tag":"Paragraph","attr":{"Num":"4"},"children":[{"tag":"ParagraphNum","attr":{},"children":["４"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["前項の場合において、当該品目の製造販売に係る法第十四条第一項及び第十三項の承認は、厚生労働大臣が薬局ごとに与える。"]}]}]},{"tag":"Paragraph","attr":{"Num":"5"},"children":[{"tag":"ParagraphNum","attr":{},"children":["５"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["薬局製造販売医薬品の製造販売業の許可については、法第十二条の二の規定は、適用しない。"]}]}]},{"tag":"Paragraph","attr":{"Num":"6"},"children":[{"tag":"ParagraphNum","attr":{},"children":["６"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["第八十条第一項（第一号に係る部分に限る。）の規定により都道府県知事（薬局製造販売医薬品の製造販売をする薬局の所在地が保健所を設置する市又は特別区の区域にある場合においては、市長又は区長）が薬局製造販売医薬品の製造販売業の許可又は製造販売の承認を行うこととされている場合における第三項又は第四項の規定の適用については、これらの規定中「厚生労働大臣」とあるのは、「当該薬局の所在地の都道府県知事（その所在地が保健所を設置する市又は特別区の区域にある場合においては、市長又は区長）」とする。"]}]}]}]},{"tag":"Article","attr":{"Num":"75"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（法第八十条第八項に規定する医薬品、医療機器及び再生医療等製品に関する特例）"]},{"tag":"ArticleTitle","attr":{},"children":["第七十五条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["法第八十条第八項に規定する医薬品、医療機器、体外診断用医薬品又は再生医療等製品（緊急に使用される必要があるため、法第四十三条第一項又は第二項の検査を受けるいとまがないと認められるものとして厚生労働大臣の指定するものに限る。）については、法第四十三条の規定は、適用しない。"]}]}]},{"tag":"Paragraph","attr":{"Num":"2"},"children":[{"tag":"ParagraphNum","attr":{},"children":["２"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["法第八十条第八項に規定する医薬品又は体外診断用医薬品のうち法第四十四条第一項に規定する毒薬又は同条第二項に規定する劇薬であるもの（緊急に使用される必要があるため、その直接の容器又は直接の被包に同条第一項又は第二項の規定による記載をするいとまがないと認められるものとして厚生労働大臣の指定するものに限る。）について同条の規定を適用する場合においては、同条第一項及び第二項中「その直接の容器又は直接の被包」とあるのは、「これに添付する文書又はその容器若しくは被包」とする。"]}]}]},{"tag":"Paragraph","attr":{"Num":"3"},"children":[{"tag":"ParagraphNum","attr":{},"children":["３"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["法第八十条第八項に規定する医薬品、医療機器又は体外診断用医薬品（緊急に使用される必要があるため、その直接の容器又は直接の被包に法第五十条又は第六十八条の十七の規定による記載をするいとまがないと認められるものとして厚生労働大臣の指定するものに限る。）について法第五十条及び第六十八条の十七の規定を適用する場合においては、法第五十条及び第六十八条の十七中「その直接の容器又は直接の被包」とあるのは、「これに添付する文書又はその容器若しくは被包」とする。"]}]}]},{"tag":"Paragraph","attr":{"Num":"4"},"children":[{"tag":"ParagraphNum","attr":{},"children":["４"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["前二項に規定する厚生労働大臣の指定する医薬品、医療機器又は体外診断用医薬品については、法第五十一条（法第六十八条の十九において準用する場合を含む。）の規定は、適用しない。"]}]}]},{"tag":"Paragraph","attr":{"Num":"5"},"children":[{"tag":"ParagraphNum","attr":{},"children":["５"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["法第十四条第十項（同条第十三項（法第十九条の二第五項において準用する場合を含む。）及び法第十九条の二第五項において準用する場合を含む。）の規定により公示された医薬品、法第二十三条の二の五第十項（同条第十三項（法第二十三条の二の十七第五項において準用する場合を含む。）及び法第二十三条の二の十七第五項において準用する場合を含む。）の規定により公示された医療機器若しくは体外診断用医薬品又は法第二十三条の二十五第十項（同条第十三項（法第二十三条の三十七第五項において準用する場合を含む。）及び法第二十三条の三十七第五項において準用する場合を含む。）の規定により公示された再生医療等製品について法第五十二条第一項、第六十三条の二第一項又は第六十五条の三の規定を適用する場合においては、これらの規定中「その容器又は被包」とあるのは、「これに添付する文書又はその容器若しくは被包」とする。"]}]}]},{"tag":"Paragraph","attr":{"Num":"6"},"children":[{"tag":"ParagraphNum","attr":{},"children":["６"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["法第十四条の二の二の二第一項（法第十九条の二第五項において準用する場合を含む。）若しくは第十四条の三第一項（法第二十条第一項において準用する場合を含む。）の規定による法第十四条若しくは第十九条の二の承認を受けて製造販売がされた医薬品、法第二十三条の二の六の三第一項（法第二十三条の二の十七第五項において準用する場合を含む。）若しくは第二十三条の二の八第一項（法第二十三条の二の二十第一項において準用する場合を含む。）の規定による法第二十三条の二の五若しくは第二十三条の二の十七の承認を受けて製造販売がされた医療機器若しくは体外診断用医薬品又は法第二十三条の二十六の二第一項（法第二十三条の三十七第五項において準用する場合を含む。）若しくは第二十三条の二十八第一項（法第二十三条の四十第一項において準用する場合を含む。）の規定による法第二十三条の二十五若しくは第二十三条の三十七の承認を受けて製造販売がされた再生医療等製品について法第五十二条、第六十三条の二又は第六十五条の三の規定を適用する場合においては、法第五十二条第一項中「その容器又は被包」とあるのは「これに添付する文書（以下この項において「添付文書」という。）又はその容器若しくは被包」と、「を入手するために必要な番号、記号その他の符号が」とあるのは「及び第十四条の二の二の二第一項（第十九条の二第五項において準用する場合を含む。次項において同じ。）若しくは第十四条の三第一項（第二十条第一項において準用する場合を含む。次項において同じ。）の規定による第十四条若しくは第十九条の二の承認を受けている旨の情報を入手するために必要な番号、記号その他の符号が記載され、又は当該注意事項等情報が記載され、かつ、添付文書又はその容器若しくは被包に、当該承認を受けている旨が厚生労働省令で定めるところにより」と、同条第二項中「記載されていなければ」とあるのは「記載され、かつ、第十四条の二の二の二第一項又は第十四条の三第一項の規定による第十四条又は第十九条の二の承認を受けている旨が厚生労働省令で定めるところにより記載されていなければ」と、法第六十三条の二第一項中「その容器又は被包」とあるのは「これに添付する文書（以下この項において「添付文書」という。）又はその容器若しくは被包」と、「を入手するために必要な番号、記号その他の符号が」とあるのは「及び第二十三条の二の六の三第一項（第二十三条の二の十七第五項において準用する場合を含む。次項において同じ。）若しくは第二十三条の二の八第一項（第二十三条の二の二十第一項において準用する場合を含む。次項において同じ。）の規定による第二十三条の二の五若しくは第二十三条の二の十七の承認を受けている旨の情報を入手するために必要な番号、記号その他の符号が記載され、又は当該注意事項等情報が記載され、かつ、添付文書又はその容器若しくは被包に、当該承認を受けている旨が厚生労働省令で定めるところにより」と、同条第二項中「記載されていなければ」とあるのは「記載され、かつ、第二十三条の二の六の三第一項又は第二十三条の二の八第一項の規定による第二十三条の二の五又は第二十三条の二の十七の承認を受けている旨が厚生労働省令で定めるところにより記載されていなければ」と、法第六十五条の三中「その容器又は被包」とあるのは「これに添付する文書（以下この条において「添付文書」という。）又はその容器若しくは被包」と、「を入手するために必要な番号、記号その他の符号が」とあるのは「及び第二十三条の二十六の二第一項（第二十三条の三十七第五項において準用する場合を含む。）若しくは第二十三条の二十八第一項（第二十三条の四十第一項において準用する場合を含む。）の規定による第二十三条の二十五若しくは第二十三条の三十七の承認を受けている旨の情報を入手するために必要な番号、記号その他の符号が記載され、又は当該注意事項等情報が記載され、かつ、添付文書又はその容器若しくは被包に、当該承認を受けている旨が厚生労働省令で定めるところにより」とする。"]}]}]},{"tag":"Paragraph","attr":{"Num":"7"},"children":[{"tag":"ParagraphNum","attr":{},"children":["７"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["法第八十条第八項に規定する医薬品、医療機器、体外診断用医薬品又は再生医療等製品について法第五十四条（法第六十四条及び第六十五条の四において準用する場合を含む。以下この項において同じ。）の規定を適用する場合においては、同条中「内袋を含む」とあるのは「内袋を含む。以下この条において同じ」と、「次に掲げる事項が記載されていてはならない」とあるのは「第一号及び第三号に掲げる事項並びに第十四条の二の二の二第一項（第十九条の二第五項において準用する場合を含む。）、第十四条の三第一項（第二十条第一項において準用する場合を含む。）、第二十三条の二の六の三第一項（第二十三条の二の十七第五項において準用する場合を含む。）、第二十三条の二の八第一項（第二十三条の二の二十第一項において準用する場合を含む。）、第二十三条の二十六の二第一項（第二十三条の三十七第五項において準用する場合を含む。）又は第二十三条の二十八第一項（第二十三条の四十第一項において準用する場合を含む。）の規定による第十四条、第十九条の二、第二十三条の二の五、第二十三条の二の十七、第二十三条の二十五又は第二十三条の三十七の承認に係る当該医薬品、医療機器、体外診断用医薬品又は再生医療等製品の用途以外の用途が記載されていてはならない。ただし、医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律施行令（昭和三十六年政令第十一号）第七十五条第二項、第三項、第十項若しくは第十二項に規定する厚生労働大臣の指定する医薬品、医療機器、体外診断用医薬品若しくは再生医療等製品又はこれらの容器若しくは被包（直接の容器又は直接の被包が包装されている場合における外部の容器又は外部の被包を除く。）になされた外国語の記載については、この限りでない」とする。"]}]}]},{"tag":"Paragraph","attr":{"Num":"8"},"children":[{"tag":"ParagraphNum","attr":{},"children":["８"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["第二項、第三項、第十項及び第十二項に規定する厚生労働大臣の指定する医薬品、医療機器、体外診断用医薬品又は再生医療等製品について法第五十五条第一項（法第六十四条、第六十五条の四又は第六十八条の十九において準用する場合を含む。）の規定を適用する場合においては、同項中「第五十条から前条まで」とあるのは「第五十条、第五十二条又は前二条」と、法第六十四条において準用する同項中「第六十三条、」とあるのは「第六十三条第一項、」と、法第六十五条の四において準用する同項中「第五十一条、第五十三条」とあるのは「第五十三条」と、法第六十八条の十九において準用する同項中「第五十一条若しくは第五十三条」とあるのは「第五十三条」とする。"]}]}]},{"tag":"Paragraph","attr":{"Num":"9"},"children":[{"tag":"ParagraphNum","attr":{},"children":["９"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["法第八十条第八項に規定する医薬品、医療機器、体外診断用医薬品又は再生医療等製品について法第五十六条、第六十五条又は第六十五条の五の規定を適用する場合においては、法第五十六条中「次の各号」とあるのは「第三号又は第六号から第八号まで」と、法第六十五条中「次の各号」とあるのは「第二号又は第四号から第七号まで」と、法第六十五条の五中「次の各号」とあるのは「第二号又は第四号から第六号まで」とする。"]}]}]},{"tag":"Paragraph","attr":{"Num":"10"},"children":[{"tag":"ParagraphNum","attr":{},"children":["１０"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["法第八十条第八項に規定する医療機器（緊急に使用される必要があるため、その医療機器又はその直接の容器若しくは直接の被包に法第六十三条の規定による記載をするいとまがないと認められるものとして厚生労働大臣の指定するものに限る。）について法第六十三条第一項の規定を適用する場合においては、同項中「その医療機器又はその直接の容器若しくは直接の被包に、」とあるのは、「これに添付する文書又はその容器若しくは被包に、」とする。"]}]}]},{"tag":"Paragraph","attr":{"Num":"11"},"children":[{"tag":"ParagraphNum","attr":{},"children":["１１"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["前項に規定する厚生労働大臣の指定する医療機器については、法第六十三条第二項の規定は、適用しない。"]}]}]},{"tag":"Paragraph","attr":{"Num":"12"},"children":[{"tag":"ParagraphNum","attr":{},"children":["１２"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["法第八十条第八項に規定する再生医療等製品（緊急に使用される必要があるため、その直接の容器又は直接の被包に法第六十五条の二の規定による記載をするいとまがないと認められるものとして厚生労働大臣の指定するものに限る。）について法第六十五条の二の規定を適用する場合においては、同条中「その直接の容器又は直接の被包に、」とあるのは、「これに添付する文書又はその容器若しくは被包に、」とする。"]}]}]},{"tag":"Paragraph","attr":{"Num":"13"},"children":[{"tag":"ParagraphNum","attr":{},"children":["１３"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["前項に規定する厚生労働大臣の指定する再生医療等製品については、法第六十五条の四において準用する法第五十一条の規定は、適用しない。"]}]}]},{"tag":"Paragraph","attr":{"Num":"14"},"children":[{"tag":"ParagraphNum","attr":{},"children":["１４"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["法第八十条第八項に規定する医薬品、医療機器、体外診断用医薬品又は再生医療等製品（第六項の規定により読み替えて適用する法第五十二条第一項、第六十三条の二第一項又は第六十五条の三の規定により、当該医薬品、医療機器、体外診断用医薬品又は再生医療等製品に添付する文書又はその容器若しくは被包に、これらの規定に規定する番号、記号その他の符号が記載されているものに限る。）について法第六十八条の二第一項及び第六十八条の二の二の規定を適用する場合においては、これらの規定中「注意事項等情報」とあるのは、「注意事項等情報及び第十四条の二の二の二第一項（第十九条の二第五項において準用する場合を含む。）若しくは第十四条の三第一項（第二十条第一項において準用する場合を含む。）の規定による第十四条若しくは第十九条の二の承認を受けている旨の情報、第二十三条の二の六の三第一項（第二十三条の二の十七第五項において準用する場合を含む。）若しくは第二十三条の二の八第一項（第二十三条の二の二十第一項において準用する場合を含む。）の規定による第二十三条の二の五若しくは第二十三条の二の十七の承認を受けている旨の情報又は第二十三条の二十六の二第一項（第二十三条の三十七第五項において準用する場合を含む。）若しくは第二十三条の二十八第一項（第二十三条の四十第一項において準用する場合を含む。）の規定による第二十三条の二十五若しくは第二十三条の三十七の承認を受けている旨の情報」とする。"]}]}]},{"tag":"Paragraph","attr":{"Num":"15"},"children":[{"tag":"ParagraphNum","attr":{}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読み替えて適用される同条第三項及び第四項並びに第八十条第一項から第四項までの規定により都道府県が処理することとされている事務は、地方自治法（昭和二十二年法律第六十七号）第二条第九項第一号に規定する第一号法定受託事務とする。"]}]}]},{"tag":"Paragraph","attr":{"Num":"2"},"children":[{"tag":"ParagraphNum","attr":{},"children":["２"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["第四条第二項において読み替えて適用される同条第一項、第五条第四項において読み替えて適用される同条第二項、第六条第五項において読み替えて適用される同条第二項及び第四項、第七条第二項において読み替えて適用される同条第一項、第八条第二項において読み替えて適用される同条第一項、第十一条第二項において読み替えて適用される同条第一項、第十二条第四項において読み替えて適用される同条第二項、第十三条第五項において読み替えて適用される同条第二項及び第四項、第十四条第二項において読み替えて適用される同条第一項、第十五条第二項において読み替えて適用される同条第一項、第十九条第二項において読み替えて適用される同条第一項、第七十四条の四第六項において読み替えて適用される同条第三項及び第四項並びに第八十条第一項の規定により保健所を設置する市又は特別区が処理することとされている事務は、地方自治法第二条第九項第一号に規定する第一号法定受託事務とする。"]}]}]}]},{"tag":"Article","attr":{"Num":"82"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（権限の委任）"]},{"tag":"ArticleTitle","attr":{},"children":["第八十二条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["この政令に規定する厚生労働大臣の権限は、厚生労働省令で定めるところにより、地方厚生局長に委任することができる。"]}]}]},{"tag":"Paragraph","attr":{"Num":"2"},"children":[{"tag":"ParagraphNum","attr":{},"children":["２"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["前項の規定により地方厚生局長に委任された権限は、厚生労働省令で定めるところにより、地方厚生支局長に委任することができる。"]}]}]}]},{"tag":"Article","attr":{"Num":"83"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（動物用医薬品等）"]},{"tag":"ArticleTitle","attr":{},"children":["第八十三条"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["医薬品、医薬部外品、医療機器又は再生医療等製品であつて、専ら動物のために使用されることが目的とされているものに関しては、この政令（第二条の七、第二条の八第二項、第二条の九第二項、第二条の十、第二条の十一第一項及び前条を除く。）中「厚生労働省令」とあるのは「農林水産省令」と、「厚生労働大臣」とあるのは「農林水産大臣」と、第二条中「次のとおり」とあるのは「第一号から第三号まで、第五号から第八号まで及び第十号に掲げる法令」と、第二条の二中「都道府県知事（薬局の所在地が地域保健法（昭和二十二年法律第百一号）第五条第一項の政令で定める市（以下「保健所を設置する市」という。）又は特別区の区域にある場合においては、市長又は区長。次条から第二条の六まで及び第二条の十三において同じ。）」とあり、第四条第二項中「都道府県知事（薬局製造販売医薬品の製造販売をする薬局の所在地が保健所を設置する市又は特別区の区域にある場合においては、市長又は区長。次条第四項、第六条第五項、第七条第二項、第八条第二項及び第十九条第二項において同じ。）」とあり、及び「都道府県知事（薬局製造販売医薬品の製造販売をする薬局の所在地が保健所を設置する市又は特別区の区域にある場合においては、市長又は区長）」とあり、第五条第四項、第六条第五項、第十二条第四項及び第十三条第五項中「都道府県知事（その所在地が保健所を設置する市又は特別区の区域にある場合においては、市長又は区長）」とあり、第七条第二項中「都道府県知事（薬局製造販売医薬品の製造販売をする薬局の所在地が保健所を設置する市又は特別区の区域にある場合においては、当該許可を受けた市長又は区長）」とあり、第八条第二項及び第十九条第二項中「都道府県知事（薬局製造販売医薬品の製造販売をする薬局の所在地が保健所を設置する市又は特別区の区域にある場合においては、市長又は区長）」とあり、第十一条第二項中「都道府県知事（薬局製造販売医薬品を製造する薬局の所在地が保健所を設置する市又は特別区の区域にある場合においては、市長又は区長。次条第四項、第十三条第五項、第十四条第二項及び第十五条第二項において同じ。）」とあり、及び「都道府県知事（薬局製造販売医薬品を製造する薬局の所在地が保健所を設置する市又は特別区の区域にある場合においては、市長又は区長）」とあり、第十四条第二項中「都道府県知事（薬局製造販売医薬品を製造する薬局の所在地が保健所を設置する市又は特別区の区域にある場合においては、当該許可を受けた市長又は区長）」とあり、並びに第十五条第二項中「都道府県知事（薬局製造販売医薬品を製造する薬局の所在地が保健所を設置する市又は特別区の区域にある場合においては、市長又は区長）」とあるのは「都道府県知事」と、第二十五条の二及び第四十三条の二十八中「アメリカ合衆国、英国、カナダ、ドイツ又はフランス」とあるのは「アイルランド、アメリカ合衆国、英国、オーストラリア、オランダ、スペイン、デンマーク、ドイツ、フランス又は南アフリカ共和国」と、第四十一条の二第三号、第六十六条の二第三号、第六十七条の二第三号、第七十条第三号及び第七十九条の二第三号中「第二条各号」とあるのは「第二条第一号から第三号まで、第五号から第八号まで及び第十号」と、第四十四条中「都道府県知事（店舗販売業にあつてはその店舗の所在地が、高度管理医療機器等（法第三十九条第一項に規定する高度管理医療機器等をいう。以下同じ。）の販売業又は貸与業にあつてはその営業所の所在地が、それぞれ保健所を設置する市又は特別区の区域にある場合においては、市長又は区長。次条から第四十八条までにおいて同じ。）は、医薬品の販売業、高度管理医療機器等」とあるのは「都道府県知事は、医薬品の販売業、高度管理医療機器等（法第三十九条第一項に規定する高度管理医療機器等をいう。以下同じ。）」と、第四十八条中「及び第四十条の五第一項」とあるのは「、第四十条の五第一項及び第八十三条の二の三第一項」と、第七十四条の四第六項中「都道府県知事（薬局製造販売医薬品の製造販売をする薬局の所在地が保健所を設置する市又は特別区の区域にある場合においては、市長又は区長）」とあり、及び「都道府県知事（その所在地が保健所を設置する市又は特別区の区域にある場合においては、市長又は区長）」とあり、第八十条第一項中「都道府県知事（薬局製造販売医薬品の製造販売をし、又は薬局製造販売医薬品を製造する薬局の所在地が保健所を設置する市又は特別区の区域にある場合においては、市長又は区長）」とあり、並びに同条第八項中「都道府県知事、保健所を設置する市の市長又は特別区の区長（以下この項において「都道府県知事等」という。）」とあり、及び「都道府県知事等」とあるのは「都道府県知事」とする。"]}]}]}]}]}]},{"tag":"SupplProvision","attr":{"Extract":"true"},"children":[{"tag":"SupplProvisionLabel","attr":{},"children":["附　則"]},{"tag":"Paragraph","attr":{"Num":"1"},"children":[{"tag":"ParagraphCaption","attr":{},"children":["（施行期日）"]},{"tag":"ParagraphNum","attr":{},"children":["１"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Function":"main","Num":"1","WritingMode":"vertical"},"children":["この政令は、法の施行の日（昭和三十六年二月一日）から施行する。"]},{"tag":"Sentence","attr":{"Function":"proviso","Num":"2","WritingMode":"vertical"},"children":["ただし、別表第一の規定中、薬事法施行規則（昭和二十三年厚生省令第三十七号）別記第四号表又は動物用医薬品等取締規則（昭和二十三年農林省令第九十二号）別表に規定されていない物に係る部分は、この政令の施行の日から起算して六箇月を経過した日から施行する。"]}]}]},{"tag":"Paragraph","attr":{"Num":"2"},"children":[{"tag":"ParagraphCaption","attr":{},"children":["（薬事法施行令の廃止）"]},{"tag":"ParagraphNum","attr":{},"children":["２"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["薬事法施行令（昭和二十八年政令第二百三十号）は、廃止する。"]}]}]}]},{"tag":"SupplProvision","attr":{"AmendLawNum":"昭和三六年四月一八日政令第一〇八号"},"children":[{"t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