공포번호 19990
공포일 2024-01-09
보건복지부
Ministry of Health and Welfare
전체선택
제1장 총칙
CHAPTER I GENERAL PROVISIONS
제1조(목적)
Article 1 (Purpose)
제2조(정의)
Article 2 (Definitions)
제3조(제약기업의 책무)
Article 3 (Responsibilities of pharmaceutical enterprises)
제2장 제약산업육성ㆍ지원계획
CHAPTER II PLANS FOR FOSTERING AND SUPPORT OF PHARMACEUTICAL INDUSTRY
제4조(제약산업육성ㆍ지원종합계획)
Article 4 (Comprehensive plans for fostering and support of pharmaceutical industry)
제5조(제약산업육성ㆍ지원시행계획)
Article 5 (Implementation plans for fostering and support of pharmaceutical industry)
제6조(제약산업육성ㆍ지원위원회)
Article 6 (Committee on Fostering and Support of Pharmaceutical Industry)
제3장 혁신형 제약기업의 인증 등
CHAPTER III CERTIFICATION OF INNOVATIVE PHARMACEUTICAL ENTERPRISES
제7조(혁신형 제약기업의 인증)
Article 7 (Certification of innovative pharmaceutical industry)
제7조의2(인증서와 인증마크)
Article 7-2 (Certificates and certification marks)
제7조의3(지위의 승계)
Article 7-3 (Succession to status)
제8조(인증의 유효기간)
Article 8 (Effective period of certification)
제9조(인증의 취소)
Article 9 (Revocation of certification)
제10조(자료의 제공)
Article 10 (Provision of data)
제11조(청문)
Article 11 (Hearings)
제12조(혁신형 제약기업의 유형별 구분)
Article 12 (Categorization of innovative pharmaceutical enterprises)
제13조(혁신형 제약기업 지원)
Article 13 (Assistance to innovative pharmaceutical enterprises)
제4장 혁신형 제약기업 지원
CHAPTER IV SUPPORT OF INNOVATIVE PHARMACEUTICAL ENTERPRISES
제14조(국가연구개발사업 등 우대)
Article 14 (Preferential treatment to national research and development projects)
제15조(조세에 관한 특례)
Article 15 (Special cases in taxation)
제16조 삭제 <2022. 6. 10.>
Article 16 Deleted.
제16조의2(연구시설 건축에 관한 특례)
Article 16-2 (Special cases concerning construction of research facilities)
제17조 삭제 <2022. 6. 10.>
Article 17 Deleted.
제17조의2(약제의 상한금액 가산 등 우대)
Article 17-2 (Preferential treatment including addition to upper limit amounts of medicines)
제17조의3(각종 부담금의 면제)
Article 17-3 (Exemption from various charges)
제5장 제약기업의 연구개발
CHAPTER V RESEARCH AND DEVELOPMENT OF PHARMACEUTICAL ENTERPRISES
제18조(연구개발투자의 확대)
Article 18 (Expansion of investment in research and development)
제18조의2(임상시험지원센터의 설치ㆍ운영)
Article 18-2 (Establishment and operation of clinical trial support center)
제19조(연구개발정보의 수집과 보급)
Article 19 (Collection and diffusion of information about research and development)
제20조(연구개발 생산성 향상에 대한 포상)
Article 20 (Awards for improvement of productivity of research and development)
제21조(제약기업의 국제협력활동 지원)
Article 21 (Assistance to pharmaceutical industry in activities for international cooperation)
제22조(권한의 위탁)
Article 22 (Entrustment of authority)
제6장 벌칙
CHAPTER VI PENALTY PROVISIONS
제23조(벌칙)
Article 23 (Penalty provisions)
제24조(양벌규정)
Article 24 (Joint penalty provision)
제25조(과태료)
Article 25 (Administrative fines)
부칙 <제10519호, 2011. 3. 30.>
ADDENDA <Act No. 10519, Mar. 30, 2011>
부칙 <제11690호, 2013. 3. 23.>
ADDENDA <Act No. 11690, Mar. 23, 2013>
부칙 <제14839호, 2017. 7. 26.>
ADDENDA <Act No. 14839, Jul. 26, 2017>
부칙 <제15908호, 2018. 12. 11.>
ADDENDUM <Act No. 15908, Dec. 11, 2018>
부칙 <제16406호, 2019. 4. 30.>
ADDENDUM <Act No. 16406, Apr. 30, 2019>
부칙 <제18902호, 2022. 6. 10.>
ADDENDA <Act No. 18902, Jun. 10, 2022>
부칙 <제19990호, 2024. 1. 9.>
ADDENDA <Act No. 19990, Jan. 9, 2024>