一細胞加工物を用いる医療技術（細胞加工物として再生医療等製品（医薬品医療機器等法第二十三条の二十五又は第二十三条の三十七の承認を受けた再生医療等製品をいう。以下この条において同じ。）のみをその承認に係る用法等（用法、用量、使用方法、効能、効果及び性能をいう。以下この号において同じ。）又は人の生命及び健康に影響を与えるおそれが当該承認に係る用法等と同程度以下のものとして厚生労働省令で定める用法等で用いるものを除く。）

(i)medical technology that uses processed cells (excluding technology that uses only regenerative medicine products (meaning regenerative medicine products approved pursuant to Article 23-25 or Article 23-37 of the Act on Pharmaceuticals and Medical Devices; the same applies below in this Article) as processed cells for approval uses and conditions (meaning usage, dosage, method of use, efficacy, effect, and performance; the same applies below in this item), or for uses and conditions specified by Order of the Ministry of Health, Labour and Welfare as posing the same or lower risk to human life and health as the approval uses and conditions); and

二核酸等を用いる医療技術（核酸等として医薬品（医薬品医療機器等法第十四条又は第十九条の二の承認を受けた医薬品をいう。以下この条において同じ。）又は再生医療等製品のみをそれぞれその承認に係る用法等（医薬品にあっては用法、用量、効能及び効果をいい、再生医療等製品にあっては用法、用量、使用方法、効能、効果及び性能をいう。以下この号において同じ。）又は人の生命及び健康に影響を与えるおそれが当該承認に係る用法等と同程度以下のものとして厚生労働省令で定める用法等で用いるものを除く。）

(ii)medical technology that uses nucleic acids and related compounds (excluding technology that uses only pharmaceuticals (meaning pharmaceuticals approved pursuant to the provisions of Article 14 or Article 19-2 of the Act on Pharmaceuticals and Medical Devices; the same applies below in this Article) or regenerative medicine products as nucleic acids and related compounds for the approved uses and conditions (meaning the usage, dosage, efficacy, and effect in the case of pharmaceuticals, and the usage, dosage, method of use, efficacy, effect, and function in the case of regenerative medicine products; the same applies below in this item), or for uses and conditions specified by Order of the Ministry of Health, Labour and Welfare as posing the same or lower risk to human life and health as the approved uses and conditions).

一第四条第二項（第五条第二項において準用する場合を含む。）の規定により再生医療等を提供しようとする病院若しくは診療所又は再生医療等提供機関の管理者から再生医療等提供計画について意見を求められた場合において、当該再生医療等提供計画について再生医療等提供基準に照らして審査を行い、当該管理者に対し、再生医療等の提供の適否及び提供に当たって留意すべき事項について意見を述べること。

(i)when the administrator of a hospital, clinic, or institution providing regenerative medicine intending to provide regenerative medicine pursuant to the provisions of Article 4, paragraph (2) (including as applied mutatis mutandis pursuant to Article 5, paragraph (2)) requests an opinion on the provision plan for such medicine, the regenerative medicine committee should examine the plan in light of the provision standards for regenerative medicine and provide an opinion to the administrator regarding whether the treatment should be provided and the matters to be noted in its provision;

二第十七条第一項の規定により再生医療等提供機関の管理者から再生医療等の提供に起因するものと疑われる疾病、障害若しくは死亡又は感染症の発生に関する事項について報告を受けた場合において、必要があると認めるときは、当該管理者に対し、その原因の究明及び講ずべき措置について意見を述べること。

(ii)upon receiving a report from the administrator of an institution providing regenerative medicine, pursuant to the provisions of Article 17, paragraph (1), regarding matters concerning the occurrence of any disease, disability, death, or infectious disease suspected to be caused by the provision of regenerative medicine, and finding it necessary, the regenerative medicine committee should provide opinions to the administrator regarding the investigation of the cause of the occurrence and the measures to be taken;

三第二十条第一項の規定により再生医療等提供機関の管理者から再生医療等の提供の状況について報告を受けた場合において、必要があると認めるときは、当該管理者に対し、その再生医療等の提供に当たって留意すべき事項若しくは改善すべき事項について意見を述べ、又はその再生医療等の提供を中止すべき旨の意見を述べること。

(iii)upon receiving a report from the administrator of an institution providing regenerative medicine on the status of the provision of regenerative medicine pursuant to the provisions of Article 20, paragraph (1), and, if deemed necessary, expressing an opinion to the administrator regarding matters to be noted or improved in the provision of such treatment, or an opinion suggesting that the provision of such treatment should be discontinued; and

四前三号に掲げる場合のほか、再生医療等技術の安全性の確保等その他再生医療等の適正な提供のため必要があると認めるときは、当該再生医療等委員会の名称が記載された再生医療等提供計画に係る再生医療等提供機関の管理者に対し、当該再生医療等提供計画に記載された事項に関し意見を述べること。

(iv)in addition to the cases stated in the preceding three items, when it is deemed necessary to ensure the safety of and bioethical standards for regenerative medicine technologies and the proper provision of regenerative medicine, to provide opinions to the administrator of the institution providing regenerative medicine regarding matters described in the provision plan for regenerative medicine, including the name of the regenerative medicine committee.

一氏名又は名称及び住所並びに法人にあっては、その代表者（法人でない団体で代表者又は管理人の定めのあるものにあっては、その代表者又は管理人）の氏名

(i)the name and address of the applicant, and, if the applicant is a corporation, the name of the representative (or, if the applicant is a non-corporate organization with a designated representative or administrator, the name of the representative or administrator);

二当該再生医療等委員会の名称

(ii)the name of the regenerative medicine committee;

三当該再生医療等委員会の委員の氏名及び職業

(iii)the names and occupations of the members of the regenerative medicine committee;

四当該再生医療等委員会が第三種再生医療等提供計画のみに係る審査等業務を行う場合にあっては、その旨

(iv)a statement to that effect in cases where the regenerative medicine committee conducts review and other duties exclusively related to a provision plan for class III regenerative medicine;

五審査等業務を行う体制に関する事項

(v)matters related to the system for conducting review and other duties;

六審査等業務に関し手数料を徴収する場合にあっては、当該手数料の算定の基準

(vi)if any fee is collected for review and other duties, the criteria for calculating the fee; and

七その他厚生労働省令で定める事項

(vii)other matters specified by Order of the Ministry of Health, Labour and Welfare.

一当該再生医療等委員会の委員の略歴を記載した書類

(i)a document outlining the career histories of the members of the regenerative medicine committee;

二当該再生医療等委員会の審査等業務に関する規程

(ii)rules concerning the review and other duties of the regenerative medicine committee; and

三その他厚生労働省令で定める書類

(iii)other documents specified by Order of the Ministry of Health, Labour and Welfare.

一第一種再生医療等提供計画、第二種再生医療等提供計画及び第三種再生医療等提供計画について、第一種再生医療等、第二種再生医療等及び第三種再生医療等のそれぞれの再生医療等提供基準に照らして審査等業務を適切に実施する能力を有する者として医学又は法律学の専門家その他の厚生労働省令で定める者から構成されるものであること。

(i)with regard to plans for the provision of class I, class II, and class III regenerative medicine, the committee consists of medical or legal experts and other persons specified by Order of the Ministry of Health, Labour and Welfare who are capable of appropriately carrying out the review and other duties in accordance with the respective provision standards for class I, class II, and class III regenerative medicine;

二その委員の構成が、審査等業務の公正な実施に支障を及ぼすおそれがないものとして厚生労働省令で定める基準に適合すること。

(ii)the composition of the committee members conforms to the criteria specified by Order of the Ministry of Health, Labour and Welfare, ensuring that it is unlikely to impede the fair implementation of review and other duties;

三審査等業務の実施の方法、審査等業務に関して知り得た情報の管理及び秘密の保持の方法その他の審査等業務を適切に実施するための体制が整備されていること。

(iii)the corporation has established a system for properly implementing review and other duties, including methods for conducting these duties, managing information acquired during the process, and maintaining confidentiality;

四審査等業務に関し手数料を徴収する場合にあっては、当該手数料の算定の基準が審査等業務に要する費用に照らし、合理的なものとして厚生労働省令で定める基準に適合するものであること。

(iv)when fees are collected for review and other duties, the criteria for calculating the fees conform to those specified by Order of the Ministry of Health, Labour, as reasonable in light of the costs required for those duties; and

五前各号に掲げるもののほか、審査等業務の適切な実施のために必要なものとして厚生労働省令で定める基準に適合するものであること。

(v)beyond what is stated in the preceding items, the applicant meets other criteria specified by Order of the Ministry of Health, Labour and Welfare, as necessary for the proper implementation of review and other duties.

一拘禁刑以上の刑に処せられ、その執行を終わり、又は執行を受けることがなくなるまでの者であるとき。

(i)when the person has been sentenced to imprisonment or a more severe punishment, and the sentence has not yet been fully served or has not yet ceased to apply;

二この法律その他国民の保健医療に関する法律で政令で定めるものの規定により罰金の刑に処せられ、その執行を終わり、又は執行を受けることがなくなるまでの者であるとき。

(ii)when the person has been sentenced to a fine under the provisions of this Act or other Acts concerning citizens' health and medical care specified by Cabinet Order, and the sentence has not yet been fully served or has not yet ceased to apply;

三第三十三条第一項の規定により第一項の認定を取り消され、その認定の取消しの日から起算して三年を経過しない者（当該認定の取消しの処分に係る行政手続法（平成五年法律第八十八号）第十五条の規定による通知があった日（以下この項において「通知日」という。）前六十日以内に当該認定を取り消された法人の役員（業務を執行する社員、取締役、執行役又はこれらに準ずる者をいい、相談役、顧問その他いかなる名称を有する者であるかを問わず、法人に対し業務を執行する社員、取締役、執行役又はこれらに準ずる者と同等以上の支配力を有するものと認められる者を含む。第六号並びに第三十五条第四項第一号及び第四号において同じ。）であった者で当該認定の取消しの日から起算して三年を経過しないもの及び通知日前六十日以内に当該認定を取り消された団体の代表者又は管理人であった者で当該認定の取消しの日から起算して三年を経過しないものを含む。）であるとき。ただし、当該認定の取消しが、当該認定の取消しの処分の理由となった事実及び当該事実の発生を防止するための認定委員会設置者（次項第一号に規定する認定委員会設置者をいう。）による体制の整備についての取組の状況その他の当該事実に関して当該認定委員会設置者が有していた責任の程度を考慮して、この号本文に規定する認定の取消しに該当しないこととすることが相当であると認められる認定の取消しとして厚生労働省令で定めるものに該当する場合を除く。

(iii)if the person is one whose accreditation referred to in paragraph (1) has been revoked pursuant to the provisions of Article 33, paragraph (1), and three years have not yet passed since the date of revocation of the accreditation (this includes a person who was previously an officer of a corporation whose accreditation has been revoked within 60 days prior to the date of notice under Article 15 of the Administrative Procedures Act (Act No. 88 of 1993) relating to the revocation of the accreditation (referred to below as the "date of notice" in this paragraph) (an officer refers to members, directors, executive officers, or any other person equivalent to those who execute the business, including those found to have control over the corporation that is equivalent to or greater than that of members, directors, executive officers, or any other person equivalent to those who execute the business; the same applies in item (vi) and Article 35, paragraph (4), items (i) and (iv)), and for whom three years have not yet passed since the date of revocation of the accreditation; or a person who was previously the representative or administrator of an organization whose accreditation has been revoked within 60 days prior to the date of notice, and for whom three years have not yet passed since the date of revocation of the accreditation); provided, however, that this does not apply if the revocation of the accreditation falls under circumstances specified by Order of the Ministry of Health, Labour and Welfare, whereby it is determined that the revocation should not be considered in the same manner as the revocation described in the main clause of this item, based on factors such as the facts constituting the grounds for the revocation, the status of efforts made by the establisher of the certified committee (as defined in item (i) of the following paragraph) to establish a system for preventing the occurrence of those facts, and the degree of responsibility of the establisher of the certified committee with respect to those facts;

四第三十三条第一項の規定による第一項の認定の取消しの処分に係る通知日から当該処分をする日又は処分をしないことを決定する日までの間に第三十条第一項の規定による廃止の届出をした者（当該廃止について相当の理由がある者を除く。）で、当該届出の日から起算して三年を経過しないものであるとき。

(iv)a person that has filed a notification of discontinuation under the provisions of Article 30, paragraph (1) during the period from the date of notification of the revocation of the accreditation referred to in paragraph (1) under the provisions of Article 33, paragraph (1) to the date of the revocation or the date of the decision not to revoke the accreditation (excluding a person that has reasonable grounds for the discontinuation), provided that it has not been three years since the date of the notification;

五第一項の認定の申請前三年以内に審査等業務に関し不正又は著しく不当な行為をした者であるとき。

(v)when the person has committed a wrongful or significantly unjustifiable act in relation to the review and other duties within three years prior to the application for accreditation referred to in paragraph (1);

六法人であって、その役員のうちに前各号のいずれかに該当する者があるとき。

(vi)a corporation whose officers fall under any of the preceding items; or

七法人でない団体であって、その代表者又は管理人のうちに第一号から第五号までのいずれかに該当する者があるとき。

(vii)a non-corporate organization whose representative or administrator falls under any of items (i) through (v).

一当該認定を受けた者（以下「認定委員会設置者」という。）の氏名又は名称及び住所

(i)the name and address of the person who has been authorized (referred to below as the "establisher of the certified committee");

二当該認定に係る再生医療等委員会（以下「認定再生医療等委員会」という。）の名称

(ii)the name of the regenerative medicine committee related to the accreditation (referred to below as the "certified committee for regenerative medicine"); and

三当該再生医療等委員会が第三種再生医療等提供計画のみに係る審査等業務を行うものとして認定された場合には、その旨

(iii)in cases where the regenerative medicine committee has been authorized to conduct review and other duties exclusively related to the provision plan for class III regenerative medicine, a statement to that effect.

一偽りその他不正の手段により第二十六条第一項の認定、第二十七条第一項の変更の認定又は第二十八条第二項の有効期間の更新を受けたとき。

(i)when the accreditation under Article 26, paragraph (1), the approval for changes under Article 27, paragraph (1), or the renewal of the validity period under Article 28, paragraph (2) has been obtained through deception or other wrongful means;

二その設置する認定再生医療等委員会が第二十六条第四項各号に掲げる要件（当該認定再生医療等委員会が第三種再生医療等提供計画のみに係る審査等業務を行う場合にあっては、同項第一号（第三種再生医療等提供計画に係る部分を除く。）に掲げる要件を除く。）のいずれかに適合しなくなったとき。

(ii)when the established certified committee for regenerative medicine no longer meets any of the requirements specified in the items of Article 26, paragraph (4) (excluding the requirement stated in item (i) of the same paragraph, except for the part relating to the provision plan for class III regenerative medicine, in cases where the certified committee for regenerative medicine conducts review and other duties exclusively related to that plan);

三第二十六条第五項各号（第三号及び第四号を除く。）のいずれかに該当するに至ったとき。

(iii)when the establisher has come to fall under any of the items listed in Article 26, paragraph (5) (excluding items (iii) and (iv));

四第三十一条第一項の報告をせず、若しくは虚偽の報告をし、同項の規定による立入検査を拒み、妨げ、若しくは忌避し、又は同項の規定による質問に対し、正当な理由なしに答弁せず、若しくは虚偽の答弁をしたとき。

(iv)when the establisher has failed to make the report specified in Article 31, paragraph (1), has made a false report, has refused, obstructed, or evaded an on-site inspection under the provisions of the same paragraph, or has failed to respond without legitimate grounds or has provided a false response to the questions under the provisions of the same paragraph; or

五前各号に掲げるもののほか、この章の規定又はこの章の規定に基づく命令若しくは処分に違反したとき。

(v)beyond what is stated in the preceding items, when the establisher has violated the provisions of this Chapter or any order or disposition issued based on its provisions.

一氏名又は名称及び住所並びに法人にあっては、その代表者の氏名

(i)the name and address of the applicant, and, if the applicant is a corporation, the name of its representative;

二特定細胞加工物等製造施設の管理者の氏名及び略歴

(ii)the name and career history of the administrator of the manufacturing facility of specific processed cells, specific nucleic acids, and related compounds;

三製造をしようとする特定細胞加工物等の種類

(iii)the type of specific processed cells, specific nucleic acids, and related compounds to be manufactured; and

四その他厚生労働省令で定める事項

(iv)other matters specified by Order of the Ministry of Health, Labour and Welfare.

一第四十九条の規定により許可を取り消され、その取消しの日から三年を経過しない者（当該許可を取り消された者が法人である場合においては、当該取消しの処分に係る行政手続法第十五条の規定による通知があった日前六十日以内に当該法人の役員であった者で当該取消しの日から三年を経過しないものを含む。）

(i)a person whose permission has been revoked pursuant to the provisions of Article 49, if three years have not passed from the date of the revocation (if the revoked party is a corporation, this includes any person who was an officer of the corporation within 60 days prior to the date of the notice under Article 15 of the Administrative Procedure Act concerning the revocation, provided that three years have not passed from the date of the revocation);

二拘禁刑以上の刑に処せられ、その執行を終わり、又は執行を受けることがなくなった日から三年を経過しない者

(ii)a person who has been sentenced to imprisonment or a more severe punishment, and for whom three years have not yet passed since completing the sentence or ceasing to be subject to its enforcement;

三前二号に該当する者を除くほか、この法律、移植に用いる造血幹細胞の適切な提供の推進に関する法律（平成二十四年法律第九十号）若しくは医薬品医療機器等法その他薬事に関する法令で政令で定めるもの又はこれらに基づく処分に違反し、その違反行為があった日から二年を経過しない者

(iii)a person, other than those falling under the preceding two items, who has violated this Act; the Act on the Appropriate Provision of Hematopoietic Stem Cells for Transplantation (Act No. 90 of 2012); the Act on Pharmaceuticals and Medical Devices; other pharmaceutical laws and regulations specified by Cabinet Order; or any disposition based on these laws and regulations, and for whom two years have not elapsed since the date of the violation; or

四法人であって、その業務を行う役員のうちに前三号のいずれかに該当する者があるもの

(iv)a corporation whose officers in charge of its business fall under any of the preceding three items.

一氏名又は名称及び住所並びに法人にあっては、その代表者の氏名

(i)the name and address of the applicant, and, if the applicant is a corporation, the name of its representative;

二特定細胞加工物等製造施設の管理者の氏名及び略歴

(ii)the name and career history of the administrator of the manufacturing facility of specific processed cells, specific nucleic acids, and related compounds;

三製造をしようとする特定細胞加工物等の種類

(iii)the type of specific processed cells, specific nucleic acids, and related compounds to be manufactured; and

四その他厚生労働省令で定める事項

(iv)other matters specified by Order of the Ministry of Health, Labour and Welfare.

一当該許可に係る特定細胞加工物等製造施設の構造設備が第四十二条の基準に適合しなくなったとき。

(i)when the structure and equipment of the manufacturing facility of specific processed cells, specific nucleic acids, and related compounds under the permission no longer conform to the standards referred to in Article 42;

二第三十五条第四項各号のいずれかに該当するに至ったとき。

(ii)when the permitted manufacturer has come to fall under any of the items in Article 35, paragraph (4); or

三前二号に掲げる場合のほか、この法律、移植に用いる造血幹細胞の適切な提供の推進に関する法律若しくは医薬品医療機器等法その他薬事に関する法令で政令で定めるもの又はこれらに基づく処分に違反したとき。

(iii)beyond the cases stated in the preceding two items, when the recipient of the delivery of goods violates this Act, the Act on the Appropriate Provision of Hematopoietic Stem Cells for Transplantation, the Act on Pharmaceuticals and Medical Devices, other pharmaceutical laws and regulations specified by Cabinet Order, or any disposition based on these Acts.

一厚生労働大臣が、必要があると認めて、当該認定事業者に対し、厚生労働省令で定めるところにより必要な報告を求めた場合において、その報告がされず、又は虚偽の報告がされたとき。

(i)if the Minister of Health, Labour and Welfare finds it necessary and requests the certified manufacturer to make a necessary report pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, and the certified manufacturer fails to make the report or makes a false report;

二厚生労働大臣が、必要があると認めて、当該職員に、当該認定事業者の当該認定に係る特定細胞加工物等製造施設又は事務所においてその構造設備又は帳簿、書類その他の物件を検査させ、関係者に質問させようとした場合において、その検査が拒まれ、妨げられ、若しくは忌避され、又はその質問に対し、正当な理由なしに答弁がされず、若しくは虚偽の答弁がされたとき。

(ii)when the Minister of Health, Labour and Welfare finds it necessary and has attempted to have the relevant officials inspect the structure and equipment, or books, documents, and other items, and question the relevant persons at the manufacturing facility of specific processed cells, specific nucleic acids, and related compounds or at the office related to the relevant certification of the certified manufacturer, and the persons have refused, obstructed, or evaded the inspection, or have failed to respond without legitimate grounds or provided false responses to the questions;

三次項において準用する第四十八条の規定による請求に応じなかったとき。

(iii)when the certified manufacturer has failed to respond to a request made under the provisions of Article 48 as applied mutatis mutandis pursuant to the following paragraph; or

四この法律、移植に用いる造血幹細胞の適切な提供の推進に関する法律若しくは医薬品医療機器等法その他薬事に関する法令で政令で定めるもの又はこれらに基づく処分に違反したとき。

(iv)when the certified manufacturer has violated any of the provisions of this Act, the Act on the Appropriate Provision of Hematopoietic Stem Cells for Transplantation, the Act on Pharmaceuticals and Medical Devices, other pharmaceutical laws and regulations specified by Cabinet Order, or any of the dispositions based on these.

一当該届出に係る特定細胞加工物等製造施設の構造設備が第四十二条の基準に適合しなくなったとき。

(i)when the structure and equipment of the manufacturing facility of specific processed cells, specific nucleic acids, and related compounds relating to the notification no longer conform to the standards referred to in Article 42;

二第三十五条第四項各号のいずれかに該当するに至ったとき。

(ii)when the notified manufacturer has come to fall under any of the items in Article 35, paragraph (4); or

三前二号に掲げる場合のほか、この法律、移植に用いる造血幹細胞の適切な提供の推進に関する法律若しくは医薬品医療機器等法その他薬事に関する法令で政令で定めるもの又はこれらの規定に基づく処分に違反したとき。

(iii)in addition to the cases stated in the preceding two items, when the notified manufacturer violates this Act, the Act on the Appropriate Provision of Hematopoietic Stem Cells for Transplantation, the Act on Pharmaceuticals and Medical Devices, other pharmaceutical laws and regulations specified by Cabinet Order, or any disposition issued based on these provisions.

一第二条第二項の政令の制定又は改廃の立案をしようとするとき。

(i)when intending to propose the enactment, amendment, or repeal of the Cabinet Order referred to in Article 2, paragraph (2);

二第二条第二項第一号若しくは第二号、第七項若しくは第八項の厚生労働省令又は第四十条第一項の特定細胞加工物等製造施設を定める厚生労働省令を制定し、又は改廃しようとするとき。

(ii)when establishing, amending, or repealing an Order of the Ministry of Health, Labour and Welfare referred to in Article 2, paragraph (2), item (i) or (ii), paragraph (7) or (8), or an Order of the Ministry of Health, Labour and Welfare that specifies a manufacturing facility of specific processed cells, specific nucleic acids, and related compounds referred to in Article 40, paragraph (1);

三再生医療等提供基準を定め、又は変更しようとするとき。

(iii)when intending to establish or change the provision standards for regenerative medicine; or

四第八条第一項（第十条第一項において準用する場合を含む。）の規定による命令をしようとするとき。

(iv)when intending to issue an order under the provisions of Article 8, paragraph (1) (including as applied mutatis mutandis pursuant to Article 10, paragraph (1)).

一第三十六条第一項の許可の更新を申請する者

(i)a person who applies for the renewal of the permission referred to in Article 36, paragraph (1); and

二第三十九条第二項において準用する第三十六条第一項の認定の更新を申請する者

(ii)a person who applies for the renewal of the certification provided for in Article 36, paragraph (1), as applied mutatis mutandis pursuant to Article 39, paragraph (2).

一第四条第一項の規定に違反して、第一種再生医療等提供計画を提出せず、又はこれに記載すべき事項を記載せず、若しくは虚偽の記載をしてこれを提出して、第一種再生医療等を提供したとき。

(i)when a person, in violation of the provisions of Article 4, paragraph (1), provides class I regenerative medicine without submitting a provision plan for class I regenerative medicine, or submits such a plan that omits required information or contains false statements;

二第五条第一項の規定に違反して、変更後の第一種再生医療等提供計画を提出せず、又はこれに記載すべき事項を記載せず、若しくは虚偽の記載をしてこれを提出して、第一種再生医療等を提供したとき。

(ii)when a person, in violation of the provisions of Article 5, paragraph (1), provides class I regenerative medicine without submitting a revised provision plan for class I regenerative medicine, or submits such a plan that omits required information, or contains false statements;

三第八条第一項（第十条第一項において準用する場合を含む。）の規定による命令に違反したとき。

(iii)when a person has violated an order issued under the provisions of Article 8, paragraph (1) (including as applied mutatis mutandis pursuant to Article 10, paragraph (1));

四第九条（第十条第一項において準用する場合を含む。）の規定に違反したとき。

(iv)when a person has violated the provisions of Article 9 (including as applied mutatis mutandis pursuant to Article 10, paragraph (1));

五第十三条の規定に違反して第一種再生医療等を行ったとき。

(v)when a person has provided class I regenerative medicine in violation of the provisions of Article 13; or

六第二十三条第二項（第一種再生医療等に係る部分に限る。）の規定による命令に違反したとき。

(vi)when a person has violated an order issued under the provisions of Article 23, paragraph (2) (limited to the part relating to class I regenerative medicine).

一第三十五条第一項の規定に違反して許可を受けないで特定細胞加工物等の製造をしたとき。

(i)when the person manufactures specific processed cells, specific nucleic acids, and related compounds without obtaining permission, in violation of the provisions of Article 35, paragraph (1);

二第四十七条の規定による命令に違反したとき。

(ii)when the person violates an order issued pursuant to the provisions of Article 47;

三第四十八条第一項の規定による特定細胞加工物等製造施設の使用禁止の処分（許可事業者に対するものに限る。）に違反したとき。

(iii)when the person violates a disposition prohibiting the use of manufacturing facilities that produce specific processed cells, specific nucleic acids, and related compounds under the provisions of Article 48, paragraph (1) (limited to dispositions against permitted manufacturers);

四第四十八条第二項の規定による命令（許可事業者に対するものに限る。）に違反したとき。

(iv)when the person violates an order issued pursuant to the provisions of Article 48, paragraph (2) (limited to orders issued to permitted manufacturers); or

五第四十九条の規定による命令に違反したとき。

(v)when the person violates an order issued pursuant to the provisions of Article 49.

一第四条第一項の規定に違反して、再生医療等提供計画を提出せず、又はこれに記載すべき事項を記載せず、若しくは虚偽の記載をしてこれを提出して、再生医療等を提供したとき（第六十条第一項第一号の規定に該当する場合を除く。）。

(i)when the person provides regenerative medicine, in violation of the provisions of Article 4, paragraph (1), without submitting a provision plan for regenerative medicine, or submits such a plan that omits required information or contains false statements (excluding cases falling under the provisions of Article 60, paragraph (1), item (i));

二第五条第一項の規定に違反して、変更後の再生医療等提供計画を提出せず、又はこれに記載すべき事項を記載せず、若しくは虚偽の記載をしてこれを提出して、再生医療等を提供したとき（第六十条第一項第二号の規定に該当する場合を除く。）。

(ii)when the person provides regenerative medicine in violation of the provisions of Article 5, paragraph (1), without submitting a revised provision plan for regenerative medicine, or submits such a plan that omits required information or contains false statements (excluding cases falling under the provisions of Article 60, paragraph (1), item (ii));

三第十三条の規定に違反して再生医療等を行ったとき（第六十条第一項第五号の規定に該当する場合を除く。）。

(iii)when regenerative medicine is performed in violation of the provisions of Article 13 (excluding cases falling under the provisions of Article 60, paragraph (1), item (v));

四第十六条第一項の規定に違反して記録を作成せず、又は虚偽の記録を作成したとき。

(iv)when the person fails to prepare a record or prepares a false record in violation of the provisions of Article 16, paragraph (1);

五第十六条第二項の規定に違反して記録を保存しなかったとき。

(v)when the person fails to preserve records in violation of the provisions of Article 16, paragraph (2);

六第二十三条第二項（第一種再生医療等に係る部分を除く。）の規定による命令に違反したとき。

(vi)when the person violates an order issued pursuant to Article 23, paragraph (2) (excluding the part relating to class I regenerative medicine); or

七第二十四条第一項若しくは第二項の報告をせず、若しくは虚偽の報告をし、同条第一項若しくは第二項の規定による立入検査を拒み、妨げ、若しくは忌避し、又は同条第一項若しくは第二項の規定による質問に対し、正当な理由なしに答弁せず、若しくは虚偽の答弁をしたとき。

(vii)when the person fails to report as required under Article 24, paragraph (1) or (2), makes a false report, refuses, obstructs, or evades an on-site inspection under the provisions of paragraph (1) or (2) of the same Article, fails to respond without legitimate grounds, or provides a false response to questions under the provisions of paragraph (1) or (2) of the same Article.

一第四十条第一項の規定に違反して、届出をしないで、又は虚偽の届出をして、特定細胞加工物等の製造をしたとき。

(i)when the person manufactures specific processed cells, specific nucleic acids, and related compounds without making a notification, or makes a false notification, in violation of the provisions of Article 40, paragraph (1);

二第四十八条第一項の規定による特定細胞加工物等製造施設の使用禁止の処分（許可事業者に対するものを除く。）に違反したとき。

(ii)when the person violates a disposition prohibiting the use of manufacturing facilities that produce specific processed cells, specific nucleic acids, and related compounds under the provisions of Article 48, paragraph (1) (excluding dispositions against permitted manufacturers);

三第四十八条第二項の規定による命令（許可事業者に対するものを除く。）に違反したとき。

(iii)when the person violates an order issued pursuant to the provisions of Article 48, paragraph (2) (excluding orders issued to permitted manufacturers);

四第五十一条の規定による命令に違反したとき。

(iv)when the person violates an order issued pursuant to the provisions of Article 51; or

五第五十二条第一項若しくは第二項の報告をせず、若しくは虚偽の報告をし、同条第一項若しくは第二項の規定による立入検査（第五十三条第一項の規定により機構が行うものを含む。）を拒み、妨げ、若しくは忌避し、又は第五十二条第一項若しくは第二項の規定による質問（第五十三条第一項の規定により機構が行うものを含む。）に対し、正当な理由なしに答弁せず、若しくは虚偽の答弁をしたとき。

(v)when the person fails to report as required under Article 52, paragraph (1) or (2), makes a false report, refuses, obstructs, or evades an on-site inspection under the provisions of paragraph (1) or (2) of the same Article (including inspections conducted by the PMDA pursuant to the provisions of Article 53, paragraph (1)), fails to respond without legitimate grounds, or provides a false response to questions under the provisions of Article 52, paragraph (1) or (2) (including questions asked by the PMDA pursuant to the provisions of Article 53, paragraph (1)).