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(영문) 울산지방법원 2011.06.24 2011노261
의료법위반
Text

The prosecutor's appeal is dismissed.

Reasons

1. In light of the purport of the grounds for appeal, the former Medical Service Act (amended by Act No. 9932, Jan. 18, 2010; hereinafter “former Medical Service Act”) provides that where anyone requests a new health technology assessment and the Minister of Health and Welfare deems it necessary to conduct a new health technology assessment, the former Medical Service Act stipulates that if a person who newly developed the health technology wishes to do so, he/she shall file an application for a new health technology assessment. Since the Defendant did not file an application for a new health technology assessment and advertised “self-local stem cell transplantation,” the instant facts charged are guilty, the lower court erred by misapprehending the legal doctrine, which affected the conclusion of the judgment.

2. In light of the determination, Article 3 of the former Regulations on the Evaluation of New Medical Technology (amended by Ordinance of the Ministry of Health and Welfare No. 0001, Mar. 19, 2010; hereinafter “former Regulations on the Evaluation of New Medical Technology”) provides that anyone may request a new health technology assessment and undergo a new health technology assessment. However, Article 53 of the former Medical Service Act and Article 2 of the former Rules on the Evaluation of New Medical Technology limit the subject of new health technology assessment to “new health technology which is deemed necessary to assess its safety and effectiveness” and Article 3(3) of the former Regulations on the Evaluation of New Medical Technology (amended by Ordinance of the Ministry of Health and Welfare).

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