{"attached_files_info":null,"law_info":{"law_type":"CabinetOrder","law_id":"426CO0000000269","law_num":"平成二十六年政令第二百六十九号","law_num_era":"Heisei","law_num_year":26,"law_num_type":"CabinetOrder","law_num_num":"269","promulgation_date":"2014-07-30"},"revision_info":{"law_revision_id":"426CO0000000269_20141125_000000000000000","law_type":"CabinetOrder","law_title":"薬事法等の一部を改正する法律の施行に伴う関係政令の整備等及び経過措置に関する政令","law_title_kana":"やくじほうとうのいちぶをかいせいするほうりつのしこうにともなうかんけいせいれいのせいびとうおよびけいかそちにかんするせいれい","abbrev":"","category":"厚生","updated":"2024-07-21T10:56:43+09:00","amendment_promulgate_date":"2014-07-30","amendment_enforcement_date":"2014-11-25","amendment_enforcement_comment":null,"amendment_scheduled_enforcement_date":null,"amendment_law_id":null,"amendment_law_title":null,"amendment_law_title_kana":"","amendment_law_num":null,"amendment_type":"1","repeal_status":"None","repeal_date":null,"remain_in_force":false,"mission":"New","current_revision_status":"CurrentEnforced"},"law_full_text":{"tag":"Law","attr":{"Era":"Heisei","Lang":"ja","LawType":"CabinetOrder","Num":"269","Year":"26","PromulgateMonth":"07","PromulgateDay":"30"},"children":[{"tag":"LawNum","attr":{},"children":["平成二十六年政令第二百六十九号"]},{"tag":"LawBody","attr":{},"children":[{"tag":"LawTitle","attr":{"Kana":"やくじほうとうのいちぶをかいせいするほうりつのしこうにともなうかんけいせいれいのせいびとうおよびけいかそちにかんするせいれい","Abbrev":"","AbbrevKana":""},"children":["薬事法等の一部を改正する法律の施行に伴う関係政令の整備等及び経過措置に関する政令"]},{"tag":"EnactStatement","attr":{},"children":["内閣は、薬事法等の一部を改正する法律（平成二十五年法律第八十四号）の施行に伴い、並びに同法附則第百二条及び関係法律の規定に基づき、並びに医薬品、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（昭和三十五年法律第百四十五号）を実施するため、この政令を制定する。"]},{"tag":"TOC","attr":{},"children":[{"tag":"TOCLabel","attr":{},"children":["目次"]},{"tag":"TOCChapter","attr":{"Delete":"false","Num":"1"},"children":[{"tag":"ChapterTitle","attr":{},"children":["第一章　関係政令の整備等"]},{"tag":"ArticleRange","attr":{},"children":["（第一条―第十七条）"]}]},{"tag":"TOCChapter","attr":{"Delete":"false","Num":"2"},"children":[{"tag":"ChapterTitle","attr":{},"children":["第二章　経過措置"]},{"tag":"ArticleRange","attr":{},"children":["（第十八条―第二十四条）"]}]},{"tag":"TOCSupplProvision","attr":{},"children":[{"tag":"SupplProvisionLabel","attr":{},"children":["附則"]}]}]},{"tag":"MainProvision","attr":{"Extract":"true"},"children":[{"tag":"Chapter","attr":{"Num":"2"},"children":[{"tag":"ChapterTitle","attr":{},"children":["第二章　経過措置"]},{"tag":"Article","attr":{"Delete":"false","Hide":"false","Num":"18"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（医療機器の製造販売の認証の申請に関する経過措置）"]},{"tag":"ArticleTitle","attr":{},"children":["第十八条"]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"1","OldStyle":"false"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["薬事法等の一部を改正する法律（以下「改正法」という。）の施行前にされた改正法第一条の規定による改正前の薬事法（附則第二条、第三条及び第五条第三項第一号において「旧薬事法」という。）第二十三条の二の認証の申請であって、改正法の施行の際、認証をするかどうかの処分がされていないものについての処分については、なお従前の例による。"]}]}]}]},{"tag":"Article","attr":{"Delete":"false","Hide":"false","Num":"19"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（高度管理医療機器等の貸与業の許可に関する経過措置）"]},{"tag":"ArticleTitle","attr":{},"children":["第十九条"]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"1","OldStyle":"false"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["改正法第一条の規定による改正後の医薬品、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（以下「医薬品医療機器等法」という。）第三十九条第一項に規定する高度管理医療機器等であって厚生労働大臣が指定するものを業として貸与し、又は貸与の目的で陳列する者（賃貸し、又は賃貸の目的で陳列する者を除く。次条において同じ。）は、当分の間、同項の許可を受けることを要しない。"]}]}]}]},{"tag":"Article","attr":{"Delete":"false","Hide":"false","Num":"20"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（管理医療機器の貸与業の届出に関する経過措置）"]},{"tag":"ArticleTitle","attr":{},"children":["第二十条"]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"1","OldStyle":"false"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["医薬品医療機器等法第三十九条の三第一項に規定する管理医療機器であって厚生労働大臣が指定するものを業として貸与し、又は貸与の目的で陳列する者は、当分の間、同項の規定による届出を要しない。"]}]}]}]},{"tag":"Article","attr":{"Delete":"false","Hide":"false","Num":"21"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（承認対象プログラム医療機器の取扱いに関する経過措置）"]},{"tag":"ArticleTitle","attr":{},"children":["第二十一条"]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"1","OldStyle":"false"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["改正法附則第九条第一項に規定する承認対象プログラム医療機器（以下この条において「承認対象プログラム医療機器」という。）であって、改正法の施行の際現に承認対象プログラム医療機器の製造販売をしている者が改正法の施行の日（以下この条において「施行日」という。）から起算して三月を経過する日（次の各号に掲げる場合にあっては、当該各号に定める日）までに販売し、授与し、若しくは貸与し、又は電気通信回線を通じて提供したものについては、医薬品医療機器等法第六十三条及び第六十三条の二並びに医薬品医療機器等法第六十四条において準用する医薬品医療機器等法第五十三条、第五十四条及び第五十五条第一項の規定は、適用しない。"]}]},{"tag":"Item","attr":{"Delete":"false","Hide":"false","Num":"1"},"children":[{"tag":"ItemTitle","attr":{},"children":["一"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Column","attr":{"LineBreak":"false","Num":"1"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["当該承認対象プログラム医療機器の製造販売をしている者が施行日から起算して三月を経過する日までに医薬品医療機器等法第二十三条の二の五第一項の承認の処分を受けた場合"]}]},{"tag":"Column","attr":{"LineBreak":"false","Num":"2"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["当該処分を受けた日から起算して三十日を経過する日又は施行日から起算して三月を経過する日のいずれか遅い日"]}]}]}]},{"tag":"Item","attr":{"Delete":"false","Hide":"false","Num":"2"},"children":[{"tag":"ItemTitle","attr":{},"children":["二"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Column","attr":{"LineBreak":"false","Num":"1"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["前号に規定する者が施行日から起算して三月を経過する日までに医薬品医療機器等法第二十三条の二の五第一項の承認の拒否の処分を受けた場合"]}]},{"tag":"Column","attr":{"LineBreak":"false","Num":"2"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["当該処分を受けた日"]}]}]}]},{"tag":"Item","attr":{"Delete":"false","Hide":"false","Num":"3"},"children":[{"tag":"ItemTitle","attr":{},"children":["三"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Column","attr":{"LineBreak":"false","Num":"1"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["第一号に規定する者が施行日から起算して三月を経過する日までに医薬品医療機器等法第二十三条の二の五第一項の承認の申請をした場合において、同日までに当該承認をするかどうかの処分がされていないとき"]}]},{"tag":"Column","attr":{"LineBreak":"false","Num":"2"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["当該申請について承認の処分がある日から起算して三十日を経過する日又は承認の拒否の処分がある日"]}]}]}]},{"tag":"Item","attr":{"Delete":"false","Hide":"false","Num":"4"},"children":[{"tag":"ItemTitle","attr":{},"children":["四"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Column","attr":{"LineBreak":"false","Num":"1"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["外国において本邦に輸出される当該承認対象プログラム医療機器の製造等（医薬品医療機器等法第二条第十三項に規定する製造等をいう。）をしている者が施行日から起算して三月を経過する日までに医薬品医療機器等法第二十三条の二の十七第一項の承認の処分を受けた場合"]}]},{"tag":"Column","attr":{"LineBreak":"false","Num":"2"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["当該処分を受けた日から起算して三十日を経過する日又は施行日から起算して三月を経過する日のいずれか遅い日"]}]}]}]},{"tag":"Item","attr":{"Delete":"false","Hide":"false","Num":"5"},"children":[{"tag":"ItemTitle","attr":{},"children":["五"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Column","attr":{"LineBreak":"false","Num":"1"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["前号に規定する者が施行日から起算して三月を経過する日までに医薬品医療機器等法第二十三条の二の十七第一項の承認の拒否の処分を受けた場合"]}]},{"tag":"Column","attr":{"LineBreak":"false","Num":"2"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["当該処分を受けた日"]}]}]}]},{"tag":"Item","attr":{"Delete":"false","Hide":"false","Num":"6"},"children":[{"tag":"ItemTitle","attr":{},"children":["六"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Column","attr":{"LineBreak":"false","Num":"1"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["第四号に規定する者が施行日から起算して三月を経過する日までに医薬品医療機器等法第二十三条の二の十七第一項の承認の申請をした場合において、同日までに当該承認をするかどうかの処分がされていないとき"]}]},{"tag":"Column","attr":{"LineBreak":"false","Num":"2"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["当該申請について承認の処分がある日から起算して三十日を経過する日又は承認の拒否の処分がある日"]}]}]}]}]}]},{"tag":"Article","attr":{"Delete":"false","Hide":"false","Num":"22"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（副作用拠出金に関する経過措置）"]},{"tag":"ArticleTitle","attr":{},"children":["第二十二条"]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"1","OldStyle":"false"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["平成二十七年度において許可医薬品製造販売業者（改正法第五条の規定による改正後の独立行政法人医薬品医療機器総合機構法（以下「新機構法」という。）第十九条第一項に規定する許可医薬品製造販売業者をいう。）が納付すべき副作用拠出金については、次の表の上欄に掲げる同条の規定中同表の中欄に掲げる字句は、それぞれ同表の下欄に掲げる字句とする。"]}]},{"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":{"WritingMode":"vertical"},"children":["第二項"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["許可医薬品又は副作用救済給付に係る許可再生医療等製品の前年度における総出荷数量"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["薬事法等の一部を改正する法律（平成二十五年法律第八十四号）第五条の規定による改正前の第四条第五項に規定する許可医薬品（副作用救済給付に係る許可再生医療等製品に該当するものを除く。第七項において「旧許可医薬品」という。）の平成二十六年四月一日から同年十一月二十四日までの間における総出荷数量及び許可医薬品の同月二十五日から平成二十七年三月三十一日までの間における総出荷数量を合計した数量"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid","rowspan":"3"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["第七項"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["前年度において許可医薬品又は副作用救済給付に係る許可再生医療等製品（以下この項において「原因許可医薬品等」という。）"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["平成二十六年四月一日から同年十一月二十四日までの間において旧許可医薬品（以下この項において「原因旧許可医薬品」という。）及び同月二十五日から平成二十七年三月三十一日までの間において副作用救済給付の支給を決定した者に係る疾病、障害又は死亡の原因となった許可医薬品（以下この項において「原因許可医薬品」という。）"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["前年度に支給"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["平成二十六年度に支給"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["原因許可医薬品等による"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["原因旧許可医薬品及び原因許可医薬品による"]}]}]}]}]}]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"2","OldStyle":"false"},"children":[{"tag":"ParagraphNum","attr":{},"children":["２"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["平成二十七年度において副作用拠出金に係る許可再生医療等製品製造販売業者（新機構法第十九条第一項に規定する副作用拠出金に係る許可再生医療等製品製造販売業者をいう。）が納付すべき副作用拠出金については、次の表の上欄に掲げる同条の規定中同表の中欄に掲げる字句は、それぞれ同表の下欄に掲げる字句とする。"]}]},{"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":{"WritingMode":"vertical"},"children":["第二項"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["許可医薬品又は副作用救済給付に係る許可再生医療等製品の前年度における総出荷数量"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["薬事法等の一部を改正する法律（平成二十五年法律第八十四号）第五条の規定による改正前の第四条第五項に規定する許可医薬品（副作用救済給付に係る許可再生医療等製品に該当するものに限る。第七項において「副作用救済給付に係る旧許可再生医療等製品」という。）の平成二十六年四月一日から同年十一月二十四日までの間における総出荷数量及び副作用救済給付に係る許可再生医療等製品の同月二十五日から平成二十七年三月三十一日までの間における総出荷数量を合計した数量"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid","rowspan":"4"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["第七項"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["前年度において"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["平成二十六年四月一日から同年十一月二十四日までの間において"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["許可医薬品又は副作用救済給付に係る許可再生医療等製品（以下この項において「原因許可医薬品等」という。）"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["副作用救済給付に係る旧許可再生医療等製品（以下この項において「副作用救済給付に係る原因旧許可再生医療等製品」という。）及び同月二十五日から平成二十七年三月三十一日までの間において副作用救済給付の支給を決定した者に係る疾病、障害又は死亡の原因となった副作用救済給付に係る許可再生医療等製品（以下この項において「副作用救済給付に係る原因許可再生医療等製品」という。）"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["前年度に支給"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["平成二十六年度に支給"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["原因許可医薬品等による"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["副作用救済給付に係る原因旧許可再生医療等製品及び副作用救済給付に係る原因許可再生医療等製品による"]}]}]}]}]}]}]},{"tag":"Article","attr":{"Delete":"false","Hide":"false","Num":"23"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（感染拠出金に関する経過措置）"]},{"tag":"ArticleTitle","attr":{},"children":["第二十三条"]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"1","OldStyle":"false"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["平成二十七年度において許可生物由来製品製造販売業者（新機構法第二十一条第一項に規定する許可生物由来製品製造販売業者をいう。）が納付すべき感染拠出金については、次の表の上欄に掲げる同条の規定中同表の中欄に掲げる字句は、それぞれ同表の下欄に掲げる字句とする。"]}]},{"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":{"WritingMode":"vertical"},"children":["第二項"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["許可生物由来製品又は感染救済給付に係る許可再生医療等製品の前年度における総出荷数量"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["薬事法等の一部を改正する法律（平成二十五年法律第八十四号）第五条の規定による改正前の第四条第八項に規定する許可生物由来製品（感染救済給付に係る許可再生医療等製品に該当するものを除く。第七項において「旧許可生物由来製品」という。）の平成二十六年四月一日から同年十一月二十四日までの間における総出荷数量及び許可生物由来製品の同月二十五日から平成二十七年三月三十一日までの間における総出荷数量を合計した数量"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid","rowspan":"4"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["第七項"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["前年度において"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["平成二十六年四月一日から同年十一月二十四日までの間において"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["許可生物由来製品又は感染救済給付に係る許可再生医療等製品（以下この項において「原因許可生物由来製品等」という。）"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["旧許可生物由来製品（以下この項において「原因旧許可生物由来製品」という。）及び同月二十五日から平成二十七年三月三十一日までの間において感染救済給付の支給を決定した者に係る疾病、障害又は死亡の原因となった許可生物由来製品（以下この項において「原因許可生物由来製品」という。）"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["前年度に支給"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["平成二十六年度に支給"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["原因許可生物由来製品等による"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["原因旧許可生物由来製品及び原因許可生物由来製品による"]}]}]}]}]}]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"2","OldStyle":"false"},"children":[{"tag":"ParagraphNum","attr":{},"children":["２"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["平成二十七年度において感染拠出金に係る許可再生医療等製品製造販売業者（新機構法第二十一条第一項に規定する感染拠出金に係る許可再生医療等製品製造販売業者をいう。）が納付すべき感染拠出金については、次の表の上欄に掲げる同条の規定中同表の中欄に掲げる字句は、それぞれ同表の下欄に掲げる字句とする。"]}]},{"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":{"WritingMode":"vertical"},"children":["第二項"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["許可生物由来製品又は感染救済給付に係る許可再生医療等製品の前年度における総出荷数量"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["薬事法等の一部を改正する法律（平成二十五年法律第八十四号）第五条の規定による改正前の第四条第八項に規定する許可生物由来製品（感染救済給付に係る許可再生医療等製品に該当するものに限る。第七項において「感染救済給付に係る旧許可再生医療等製品」という。）の平成二十六年四月一日から同年十一月二十四日までの間における総出荷数量及び感染救済給付に係る許可再生医療等製品の同月二十五日から平成二十七年三月三十一日までの間における総出荷数量を合計した数量"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid","rowspan":"4"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["第七項"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["前年度において"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["平成二十六年四月一日から同年十一月二十四日までの間において"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["許可生物由来製品又は感染救済給付に係る許可再生医療等製品（以下この項において「原因許可生物由来製品等」という。）"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["感染救済給付に係る旧許可再生医療等製品（以下この項において「感染救済給付に係る原因旧許可再生医療等製品」という。）及び同月二十五日から平成二十七年三月三十一日までの間において感染救済給付の支給を決定した者に係る疾病、障害又は死亡の原因となった感染救済給付に係る許可再生医療等製品（以下この項において「感染救済給付に係る原因許可再生医療等製品」という。）"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["前年度に支給"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["平成二十六年度に支給"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["原因許可生物由来製品等による"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["感染救済給付に係る原因旧許可再生医療等製品及び感染救済給付に係る原因許可再生医療等製品による"]}]}]}]}]}]}]},{"tag":"Article","attr":{"Delete":"false","Hide":"false","Num":"24"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（安全対策等拠出金に関する経過措置）"]},{"tag":"ArticleTitle","attr":{},"children":["第二十四条"]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"1","OldStyle":"false"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["平成二十七年度において医薬品等製造販売業者（新機構法第二十二条第一項に規定する医薬品等製造販売業者をいう。）が納付すべき安全対策等拠出金については、同条第二項中「医薬品、医療機器又は再生医療等製品の前年度における総出荷数量」とあるのは、「薬事法等の一部を改正する法律（平成二十五年法律第八十四号）第五条の規定による改正前の第四条第一項に規定する医薬品又は同条第四項に規定する医療機器の平成二十六年四月一日から同年十一月二十四日までの間における総出荷数量及び医薬品、医療機器又は再生医療等製品の同月二十五日から平成二十七年三月三十一日までの間における総出荷数量を合計した数量」とする。"]}]}]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"2","OldStyle":"false"},"children":[{"tag":"ParagraphNum","attr":{},"children":["２"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["当分の間、新機構法第二十二条、第二十三条及び第二十五条の規定並びに第十三条の規定による改正後の独立行政法人医薬品医療機器総合機構法施行令（以下「新機構法施行令」という。）第二十四条及び第二十五条の規定は、体外診断用医薬品についても、適用する。"]},{"tag":"Sentence","attr":{"Num":"2","WritingMode":"vertical"},"children":["この場合において、次の表の上欄に掲げる新機構法及び新機構法施行令の規定中同表の中欄に掲げる字句は、それぞれ同表の下欄に掲げる字句とする。"]}]},{"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","rowspan":"2"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["新機構法第二十二条第一項"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["又は"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["若しくは"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["いう。）"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["いう。）又は各年四月一日において同法第二十三条の二第一項の規定による体外診断用医薬品の製造販売業の許可を受けている者（以下「体外診断用医薬品製造販売業者」という。）"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["新機構法第二十二条第二項及び第五項"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["医薬品等製造販売業者"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["医薬品等製造販売業者又は体外診断用医薬品製造販売業者"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["新機構法第二十三条第一項"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["又は医薬品等製造販売業者"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["、医薬品等製造販売業者又は体外診断用医薬品製造販売業者"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid","rowspan":"2"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["新機構法施行令第二十四条の表第十八条第一項の項"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["許可医薬品製造販売業者等"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["許可医薬品製造販売業者等（以下「許可医薬品製造販売業者等」という。）"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["医薬品等製造販売業者"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["医薬品等製造販売業者（以下「医薬品等製造販売業者」という。）又は各年四月一日において医薬品、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第二十三条の二第一項の規定による体外診断用医薬品の製造販売業の許可を受けている者（以下「体外診断用医薬品製造販売業者」という。）"]}]}]},{"tag":"TableRow","attr":{},"children":[{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["新機構法施行令第二十四条の表第十八条第三項から第五項まで及び第十九条の項及び第二十五条"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["医薬品等製造販売業者"]}]},{"tag":"TableColumn","attr":{"BorderBottom":"solid","BorderLeft":"solid","BorderRight":"solid","BorderTop":"solid"},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["医薬品等製造販売業者又は体外診断用医薬品製造販売業者"]}]}]}]}]}]}]}]}]},{"tag":"SupplProvision","attr":{"Extract":"true"},"children":[{"tag":"SupplProvisionLabel","attr":{},"children":["附　則"]},{"tag":"Article","attr":{"Delete":"false","Hide":"false","Num":"1"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（施行期日）"]},{"tag":"ArticleTitle","attr":{},"children":["第一条"]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"1","OldStyle":"false"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["この政令は、改正法の施行の日（平成二十六年十一月二十五日）から施行する。"]}]}]}]},{"tag":"Article","attr":{"Delete":"false","Hide":"false","Num":"2"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（外国製造医療機器等特例承認取得者に関する変更の届出に関する経過措置）"]},{"tag":"ArticleTitle","attr":{},"children":["第二条"]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"1","OldStyle":"false"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["この政令の施行前にその氏名又は住所その他第一条の規定による改正前の薬事法施行令（以下この条及び次条において「旧薬事法施行令」という。）第三十五条第一項の厚生労働省令（旧薬事法施行令第八十三条の規定が適用される場合にあっては、農林水産省令。次条において同じ。）で定める事項に変更があった医療機器又は体外診断用医薬品の外国特例承認取得者（旧薬事法第十九条の二第四項に規定する外国特例承認取得者をいい、改正法附則第三十七条の規定により医薬品医療機器等法第二十三条の三十七の承認を受けたものとみなされる者を除く。）であって、旧薬事法施行令第三十五条第一項の規定による届出をしていないものについては、第一条の規定による改正後の医薬品、医療機器等の品質、有効性及び安全性に関する法律施行令（次条において「医薬品医療機器等法施行令」という。）第三十七条の三十四第一項の規定にかかわらず、なお従前の例による。"]}]}]}]},{"tag":"Article","attr":{"Delete":"false","Hide":"false","Num":"3"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（外国製造再生医療等製品特例承認取得者に関する変更の届出に関する経過措置）"]},{"tag":"ArticleTitle","attr":{},"children":["第三条"]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"1","OldStyle":"false"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["この政令の施行前にその氏名又は住所その他旧薬事法施行令第三十五条第一項の厚生労働省令で定める事項に変更があった医薬品又は医療機器の外国特例承認取得者（旧薬事法第十九条の二第四項に規定する外国特例承認取得者をいい、改正法附則第三十七条の規定により医薬品医療機器等法第二十三条の三十七の承認を受けたものとみなされる者に限る。）であって、旧薬事法施行令第三十五条第一項の規定による届出をしていないものについては、医薬品医療機器等法施行令第四十三条の三十一第一項の規定にかかわらず、なお従前の例による。"]}]}]}]},{"tag":"Article","attr":{"Delete":"false","Hide":"false","Num":"4"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（医療機器の製造販売の承認の申請等に係る手数料の額に関する経過措置）"]},{"tag":"ArticleTitle","attr":{},"children":["第四条"]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"1","OldStyle":"false"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["改正法附則第十三条の規定によりなお従前の例によることとされた同条の再審査に係る医療機器と構造、使用方法、効果及び性能が明らかに異ならない医療機器について医薬品医療機器等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申請する者については、第二条の規定による改正後の医薬品、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関係手数料令第十二条第一項第一号イ（１）中「、その」とあるのは「その」と、「を除く」とあるのは「、薬事法等の一部を改正する法律（平成二十五年法律第八十四号。以下「改正法」という。）第一条の規定による改正前の薬事法（以下「旧法」という。）第十四条の四第一項第一号（旧法第十九条の四において準用する場合を含む。）に規定する新医療機器であってその製造販売の承認のあった日後同号に規定する調査期間（旧法第十四条の四第二項の規定による延長が行われたときは、その延長後の期間）を経過していないもの（改正法附則第三十条の規定により法第二十三条の二十五の承認を受けたものとみなされ、又は改正法附則第三十七条の規定により法第二十三条の三十七の承認を受けたものとみなされるものを除く。）及び旧法第十四条の四第一項第二号（旧法第十九条の四において準用する場合を含む。）に規定する厚生労働大臣が指示する医療機器であって同号に規定する厚生労働大臣が指示する期間を経過していないもの（改正法附則第三十条の規定により法第二十三条の二十五の承認を受けたものとみなされ、又は改正法附則第三十七条の規定により法第二十三条の三十七の承認を受けたものとみなされるものを除く。）を除く」とする。"]}]}]}]},{"tag":"Article","attr":{"Delete":"false","Hide":"false","Num":"5"},"children":[{"tag":"ArticleCaption","attr":{},"children":["（特許権の存続期間の延長登録の出願に関する経過措置）"]},{"tag":"ArticleTitle","attr":{},"children":["第五条"]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"1","OldStyle":"false"},"children":[{"tag":"ParagraphNum","attr":{},"children":[]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["この政令の施行前にした特許権の存続期間の延長登録の出願については、なお従前の例による。"]}]}]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"2","OldStyle":"false"},"children":[{"tag":"ParagraphNum","attr":{},"children":["２"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"Num":"1","WritingMode":"vertical"},"children":["この政令の施行後にした特許権の存続期間の延長登録の出願であって、次に掲げる処分に係るものについては、第七条の規定による改正前の特許法施行令第三条第二号の規定は、なおその効力を有する。"]},{"tag":"Sentence","attr":{"Num":"2","WritingMode":"vertical"},"children":["この場合において、第二号に掲げる処分に係るものに係る同条第二号の規定の適用については、同号中「薬事法」とあるのは、「薬事法等の一部を改正する法律（平成二十五年法律第八十四号）附則第六十三条の規定又は薬事法等の一部を改正する法律の施行に伴う関係政令の整備等及び経過措置に関する政令（平成二十六年政令第二百六十九号）第十八条の規定によりなお従前の例によりされた同法第一条の規定による改正前の薬事法」とする。"]}]},{"tag":"Item","attr":{"Delete":"false","Hide":"false","Num":"1"},"children":[{"tag":"ItemTitle","attr":{},"children":["一"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["第七条の規定による改正前の特許法施行令第三条第二号に掲げる処分"]}]}]},{"tag":"Item","attr":{"Delete":"false","Hide":"false","Num":"2"},"children":[{"tag":"ItemTitle","attr":{},"children":["二"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["改正法附則第六十三条の規定又は第十八条の規定によりなお従前の例によりされた前号に掲げる処分"]}]}]}]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"3","OldStyle":"false"},"children":[{"tag":"ParagraphNum","attr":{},"children":["３"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["この政令の施行後にした特許権の存続期間の延長登録の出願であって、次に掲げる処分に係るものに係る特許法施行令第二条第二号の規定の適用については、同号中「次に掲げる処分」とあるのは、「次に掲げる処分及び薬事法等の一部を改正する法律の施行に伴う関係政令の整備等及び経過措置に関する政令（平成二十六年政令第二百六十九号）附則第五条第三項各号に掲げる処分」とする。"]}]},{"tag":"Item","attr":{"Delete":"false","Hide":"false","Num":"1"},"children":[{"tag":"ItemTitle","attr":{},"children":["一"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["旧薬事法第十四条第一項に規定する医療機器（医薬品医療機器等法第二条第九項に規定する再生医療等製品に該当するものに限る。）に係る旧薬事法第十四条第一項の承認、同条第九項（旧薬事法第十九条の二第五項において準用する場合を含む。）の承認及び旧薬事法第十九条の二第一項の承認"]}]}]},{"tag":"Item","attr":{"Delete":"false","Hide":"false","Num":"2"},"children":[{"tag":"ItemTitle","attr":{},"children":["二"]},{"tag":"ItemSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["改正法附則第六十三条の規定によりなお従前の例によりされた前号に掲げる処分"]}]}]}]}]}]},{"tag":"SupplProvision","attr":{"AmendLawNum":"平成二七年一月二八日政令第二六号","Extract":"true"},"children":[{"tag":"SupplProvisionLabel","attr":{},"children":["附　則"]},{"tag":"Paragraph","attr":{"Hide":"false","Num":"1","OldStyle":"false"},"children":[{"tag":"ParagraphCaption","attr":{},"children":["（施行期日）"]},{"tag":"ParagraphNum","attr":{},"children":["１"]},{"tag":"ParagraphSentence","attr":{},"children":[{"tag":"Sentence","attr":{"WritingMode":"vertical"},"children":["この政令は、平成二十六年改正法の施行の日（平成二十七年四月一日）から施行する。"]}]}]}]}]}]}}