Article 42(Revocation of Permission and Suspension of Business) #
(1) Where a regenerative medical institution falls under any of the following subparagraphs, the Minister of Health and Welfare may revoke the designation thereof or order to fully or partially suspend its business for a period of up to one year: Provided, That he or she shall revoke such designation in cases falling under subparagraph 1:
1. Where it obtains the designation under Article 10 (1) by fraud or other improper means;
2. Where it ceases to meet the standards for designation under Article 10 (2);
3. Where it fails to comply with the standards for conducting clinical research of advanced regenerative medicine, in violation of Article 10 (4);
4. Where it charges expenses incurred in conducting clinical research of advanced regenerative medicine to a human subject, in violation of Article 10 (5);
5. Where it fails to undergo deliberation under Article 12 (1) or to obtain approval under Article 12 (3), or conducts clinical research of advanced regenerative medicine in a manner different from that deliberated and approved;
6. Where it fails to report an adverse reaction to the head of a safety management institution, in violation of Article 20 (2);
7. Where it fails to comply with any order or disposition issued under Article 39, 40, or 41;
8. Where it refuses, obstructs, or evades access, investigation, or inspection by a relevant public official provided in Article 39 (1);
9. Where it violates this Act or any orders issued under this Act.
(2) Where a manufacturer or importer of advanced biological products, person who has obtained permission by item, human cell management entity, or cell processing establishment falls under any of the following subparagraphs, the Minister of Food and Drug Safety may revoke such permission or acceptance of a report, or may order closure of a contract manufacturing business office or business place (limited to cases reported pursuant to Article 27 (1); hereafter the same shall apply in Article 43), prohibition on manufacturing of items or on importation of items, or suspension of the whole or part of the business under this Act for a period of up to one year: Provided, That he or she shall revoke such permission in cases falling under subparagraph 1. <Amended on Oct. 22, 2024>
1. Where he, she, or it obtains permission under Article 15 (1) or 28 (1) by fraud or other improper means;
2. Where he, she, or it ceases to meet the establishment standards provided in Article 15 (1), 23 (1), 27 (3) or 28 (1);
3. Where he, she, or it fails to obtain permission by item or permission for modification, in violation of Article 23 (2), (3), or (7) or Article 27 (1);
4. Where he, she, or it falls under any of the subparagraphs 1, 4-2, or 5 of Article 23 (6) (limited to an importer in cases falling under subparagraph 5): Provided, That the same shall not apply where the representative of a corporation falls under any of such provisions and is replaced within six months;
5. Where he, she, or it falls under Article 23 (6) 6 and 7 or Article 27 (4) 2: Provided, That the same shall not apply where the representative of a corporation falls under any of such provisions and is replaced within six months;
6. Where he, she, or it manufactures advanced biological products, in violation of Article 26 (1);
7. Where he, she, or it fails to files a registration or a registration of modification or fails to file a report on modification under Article 27 (7) and (8), or files a registration, a registration on modification, or a notification of modification by fraud or other improper means;
8. Where he, she, or it manages human cells, etc., in violation of Article 29;
9. Where he, she, or it fails to report a serious adverse event, in violation of Article 30 (3);
10. Where he, she, or it states information, in violation of Article 31;
11. Where he, she, or it fails to comply with any order or disposition issued under Article 39, 40, or 41;
12. Where he, she, or it refuses, interferes with, or evades the entry, inspection, inquiry, or collection by a relevant public official under Article 39 (2);
13. Where he, she, or it manufactures, imports, or distributes advanced biological products which caused or are likely to cause any risk to the public health or which are recognized as having no efficacy;
14. Where he, she, or it violates this Act or any orders issued under this Act.
(3) Detailed standards for administrative dispositions under paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare, and detailed standards for administrative dispositions under paragraph (2) shall be prescribed by Ordinance of the Prime Minister in consideration of the type, severity, etc. of the relevant violations.