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Translation - English Title: permission change instruction (unification adjustment) on Mycophenolate Mofetil single preparation (oral) – call for opinion
1. We notify that of all pharmaceuticals, ‘Mycophenolate Mofetil single preparation (oral)’ is scheduled to uniform adjustment of precaution in use, see attachment, referenced from safety.efficacy test
2. Moreover, any company in possession of target items thereof holds objection, it shall submit such opinion to us (Drug Review Management Division) before 07.27.2015, while related organization shall notify each member of this adjustment plan so any company, even if not in possession of target items, shall submit any opinion one might hold on this adjustment plan.
3. This unification adjustment (plan) and related subjects shall be up at our division’s webpage (www.mfds.go.kr)>notification board>notice which one can use upon noticing each corporate member.
※ Separately, for items that contain additives with the set precaution of use, shall be managed by a company itself to have latest safety materials registered under Article No.17 Paragraph No. 1 of 「Regulation on Pharmaceuticals Approval, Notification, and Review 」
1. unification adjustment on Mycophenolate Mofetil single preparation(oral) target items
2. Mycophenolate Mofetil single preparation(oral_tablet, capsule) comparison table for change
3. Mycophenolate Mofetil single preparation(oral_tablet, capsule) unification adjustment plan
4. Mycophenolate Mofetil single preparation(oral_powder for suspension) comparison table for change
5. Mycophenolate Mofetil single preparation(oral_powder for suspension) unification adjustment plan
6. Permission change instruction (unification adjustment) on Mycophenolate Mofetil single preparation (oral) – call for opinion.
Korean to English: Off-label Medicine evaluation procedure General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - Korean 제1조(목적) 이 지침은 약사법에 의한 품목허가(신고)받은 범위 외로 사용하고자 하는 의약품의 안전성과 유효성을 평가하기 위한 평가대상, 평가절차 및 평가결과에 관한 사항을 정함으로써 허가외 사용 의약품 평가업무에 적정을 기함을 목적으로 한다.
제2조(정의) 이 지침에서 사용하는 용어의 뜻은 다음 각 호와 같다.
1. ‘허가외 사용 의약품’이란 약사법 제31조 제2항 및 제3항 또는 제42조 제1항에 의한 허가(신고)를 받았으나, 허가(신고)받지 아니한 효능•효과, 또는 용법•용량으로 사용하고자 하는 의약품을 말한다.
2. ‘신청자(기관)’란 이 지침 제3조 제1호 및 제2호에 따라 허가외 사용 의약품에 대한 안전성•유효성 평가를 요청한 자를 말한다.
제3조 (적용 대상) 이 지침에 따라 평가하는 허가외 사용 의약품은 다음과 같다.
1.「허가 또는 신고 범위 초과 약제 비급여 사용 승인에 관한 기준 및 절차」(보건복지부 고시)에 따라 건강보험심사평가원에서 검토 요청한 품목
2. 대한의사협회, 대한약사회 등 유관 단체에서 안전성과 유효성 평가가 필요하다고 검토 요청한 품목
3. 기타 안전성과 유효성에 관한 우려로 식품의약품안전처장이 검토가 필요하다고 인정한 품목
Translation - English Article 1(Purpose) for the purpose of this evaluation procedure herein define the target, evaluation procedure, related subjects on evaluation results of Off-label Medicine per PHARMACEUTICALS AFFAIR ACT to evaluate safety and efficacy thereof and provide reasons to Off-label Medicine evaluation.
Article 2 (Definition) definitions of terms herein contained is as the following paragraph
1. ‘Off-label Medicine’ is pharmaceuticals approved(notified) in accordance to PHARMACEUTICALS AFFAIR ACT Article 31 Paragraph 2 and Paragraph 3 or Article 42 paragraph 1 that is subject to future use for effect•efficacy, or dose•dosage administration which has not been approved(notified).
2. ‘Applicant (Agency)’ is one who applied for safety and efficacy evaluation of Off-label Medicine following procedure herein, Article 3 Paragraph 1 and Paragraph 2
Article3 (Application) evaluation herein contained is applied to the following Off-label Medicine
1. Items that have been requested an assessment from Health Insurance Review & Assessment Service in accordance to 「Criteria and Procedures for the Approval of Non-reimbursement Use of Drugs Exceeding the Scope of Product Approval or Notification」(Ministry of Health and Welfare Announcement)
2. Items that have been requested evaluation on necessity basis for safety and efficacy thereof from Korean Medical Association, Korean Pharmaceutical Association, or from other relevant organization
3. Items that have been approved of the necessity of evaluation from Minister of Food and Drug Safety for other concerns on safety and efficacy.
BA in Biology and Ph.D. Student in Nanotechnology. Certified professional translator from International Interpretation & Translation Association of Korea. Part-time independent translator. Previous translation works include those in the field of psychology, Coursera subtitle for HR and IT courses, general business, and technology.