Article 44(Revocation of permission and suspension of business) #
(1) Where a person handling narcotics, a person approved to handle narcotics, or an exporter, importer of precursors falls under any of the following, the relevant authority granting permission may revoke permission (including permission for items), designation, or approval given under this Act or may issue an order to fully or partially suspend his or her business or handling of narcotics and precursors for a period of up to one year; provided, where narcotic drugs, psychotropic substances, or ultra-narcotic drugs cause or are likely to cause harm or danger to the public health due to reasons not attributable to a person handling them and where it is deemed that the objectives of permission are deemed achievable by changing the ingredients or prescription thereof, only the change may be ordered: <Amended on Mar. 23, 2013; Jul. 30, 2013; Mar. 18, 2014; May 18, 2015; Dec. 11, 2018; Dec. 13, 2019; Aug. 17, 2021; Feb. 6, 2024>
1. With regard to an order to fully or partially suspend business or handling of narcotics and precursors:
(a) Where he or she violates the provisions concerning restrictions on handling narcotics under Article 5 (1) and (2);
(b) Where he or she fails to comply with measures under Article 5 (3);
(c) Where he or she fails to obtain permission for modification or modified designation under the latter part, with the exception of the subparagraphs, of Article 6 (1) and the latter part of paragraph (2) of that Article;
(d) Where he or she fails to obtain permission for modification under the latter part Article 6-2 (1);
(e) Where he or she fails to have a certificate of permission or designation letter under Article 7 (2) re-issued;
(f) Where he or she transfers narcotics, in violation of Article 9 (2) and (3);
(g) Deleted; <May 18, 2015>
(h) Deleted; <May 18, 2015>
(i) Where he or she fails to submit a report or submits a false report, in violation of Article 11;
(j) Where he or she fails to report, or destroys, narcotics involved in an accident, in violation of Article 12;
(k) Where he or she advertises narcotics, in violation of Article 14;
(l) Where he or she stores narcotics, in violation of Article 15;
(m) Where he or she fails to seal narcotics, or gives or receives narcotics which are not sealed, in violation of Article 16;
(n) Where he or she fails to state information, in violation of Article 17, or states false information;
(o) Deleted; <May 18, 2015>
(p) Where he or she sells narcotics, in violation of Articles 20, 22, and 26;
(q) Where he or she administers a narcotic or psychotropic substance without following a prescription, in violation of Article 32, or records false information in a prescription, or fails to prepare, keep and retain a prescription;
(r) Where he or she fails to employ a manager of narcotics, in violation of Article 33;
(s) Where he or she fails to keep and retain records, in violation of Article 35 (2) through (4), or records false information;
(t) Where a cultivator of cannabis plants fails to cultivate the cannabis plants for two consecutive years without good cause;
(u) Where he or she violates obligations of control of a person handling narcotics under Article 38;
(v) Where he or she refuses, hinders, or abstains from inspections, inquiries and collection by a relevant public official under Article 41;
(w) Where the persons handling narcotics or exporters, importers of precursors fail to receive education, in violation of Article 50;
(X) Where he or she exports and imports precursors without obtaining approval for export and import, in violation of Article 51 (1), or exports and imports precursors in a manner inconsistent with approval for export and import;
(y) Where he or she fails to prepare or retain records on the manufacture, export, import, giving, receiving, sale, or purchase of precursors, in violation of Article 51 (2) or prepares false records;
(z) Where he or she trades precursors in small quantities to evade the obligation of preparing records on the export, import, giving, receiving, sale, or purchase of precursors under Article 51 (2);
(Aa) Where he or she fails to report under Article 51 (3);
(Ab) Where he or she fails to obtain approval or modified approval for export and import under Article 18 (2) 2;
2. Where permission (including permission for items), designation, or approval is revoked:
(a) Where he or she falls under a ground for disqualification under each subparagraph of Article 6 (3);
(b) Where he or she fails to obtain permission or modified permission, in violation of Article 18 (2) 1, 21 (2), or 24 (2);
(c) Where he or she violates subparagraph 1 (a), (m), or (v) or Article 9 (2) on at least two occasions;
(d) Where he or she violates subparagraph 1 (i), (j), or (r), or (Ab) or Article 9 (3) on at least three occasions;
(e) Where he or she fails to meet the standards prescribed by Prime Ministerial Decree for the content of active ingredients of narcotic drugs, rate of loss of narcotic drugs in the compounding process on at least three occasions;
(f) Where a person handling narcotics, such as a pharmacist, loses his or her qualification required to be a person handling narcotics under Article 6 (1) or (2), or the permission granted to a manufacturer or a wholesaler of pharmaceuticals under the Pharmaceutical Affairs Act is revoked;
(g) Where an exporter, importer of precursors reports to the head of the competent tax office on the closure of his or her business, or the head of the competent tax office cancels his or her business registration under Article 8 of the Value-Added Tax Act.
(h) Where he or she obtains approval under subparagraphs 2 through 7 of Article 3, Article 4 (2) 7, or paragraph (3) of that Article by fraud or other improper means;
(i) Where he or she obtains permission or permission for modification under Article 6 (1) or 6-2 (1) by fraud or other improper means;
(j) Where he or she obtains permission or permission for modification under Article 18 (2) 1, 21 (2), or 24 (2) by fraud or other improper means.
(k) Where he or she conducts business during the period of business suspension.
(2) The criteria for administrative dispositions under paragraph (1) shall be prescribed by Prime Ministerial Decree. <Amended on Mar. 23, 2013>
(3) The Minister of Food and Drug Safety may request the head of the competent tax office to provide information as to whether an exporter, importer of precursors has closed his or her business, if necessary for revoking permission for any reason under paragraph (1) 2 (g). In such cases, the head of the competent tax office shall provide information thereon under Article 36 (1) of the Electronic Government Act, unless there is a compelling reason not to do so. <Added on Dec. 11, 2018>
(4) If the authority granting permission has taken a disposition under paragraph (1) against a medical practitioner handling narcotics or a retailer of narcotics, it shall notify the Health Insurance Review and Assessment Service and the National Health Insurance Service under the National Health Insurance Act of such fact. <Added on February 6, 2024>
[This Article Wholly Amended on Jun. 7, 2011]