<p><span style="font-size: 12pt; font-family: David;">안녕하세요. </span></p> <p><span style="font-size: 12pt; font-family: David;">한국보건산업진흥원 제약바이오산업단에서 알려드립니다.</span></p> <p><span style="font-size: 12pt; font-family: David;"><br></span></p> <p style="box-sizing: border-box; margin: 0pt 0pt 0pt 33pt; padding: 0px; word-break: keep-all; text-align: justify; vertical-align: baseline; font-family: 함초롬바탕; letter-spacing: 0pt; font-size: 10pt; line-height: 24px; text-indent: -33pt;"><span style="box-sizing: border-box; font-family: David; letter-spacing: 0pt; font-size: 12pt;">□ </span><span style="box-sizing: border-box; font-family: David; font-size: 12pt;">주요 내용</span></p> <p style="box-sizing: border-box; margin: 0pt 0pt 0pt 19.4pt; padding: 0px; word-break: keep-all; text-align: justify; vertical-align: baseline; font-family: 함초롬바탕; letter-spacing: 0pt; font-size: 10pt; line-height: 24px; text-indent: -19.4pt;"><span style="box-sizing: border-box; font-family: David; letter-spacing: 0pt; font-size: 12pt;"><</span><span style="box-sizing: border-box; font-family: David; font-size: 12pt;">의약품 관리법</span><span style="box-sizing: border-box; font-family: David; letter-spacing: 0pt; font-size: 12pt;">>, <</span><span style="box-sizing: border-box; font-family: David; font-size: 12pt;">의약품 관리법 시행규칙</span><span style="box-sizing: border-box; font-family: David; letter-spacing: 0pt; font-size: 12pt;">>, <</span><span style="box-sizing: border-box; font-family: David; font-size: 12pt;">의약품 등록 및 관리 방법</span><span style="box-sizing: border-box; font-family: David; letter-spacing: 0pt; font-size: 12pt;">> </span><span style="box-sizing: border-box; font-family: David; font-size: 12pt;">상 언급된 원료의약품 관리와 관련된 요구</span></p> <p style="box-sizing: border-box; margin: 0pt 0pt 0pt 19.4pt; padding: 0px; word-break: keep-all; text-align: justify; vertical-align: baseline; font-family: 함초롬바탕; letter-spacing: 0pt; font-size: 10pt; line-height: 24px; text-indent: -19.4pt;"><span style="box-sizing: border-box; font-family: David; font-size: 12pt;">사</span><span style="box-sizing: border-box; letter-spacing: 0pt; text-indent: -19.4pt; font-family: David; font-size: 12pt;">항을 이행하기 </span><span style="box-sizing: border-box; text-indent: -19.4pt; font-family: David; letter-spacing: -0.4pt; font-size: 12pt;">위해</span><span style="box-sizing: border-box; text-indent: -19.4pt; font-family: David; letter-spacing: -0.4pt; font-size: 12pt;">, </span><span style="box-sizing: border-box; text-indent: -19.4pt; font-family: David; letter-spacing: -0.4pt; font-size: 12pt;">원료의약품 승인 통지서 발급 및 재등록 관리 등에 관한 사항을</span><span style="box-sizing: border-box; letter-spacing: 0pt; text-indent: -19.4pt; font-family: David; font-size: 12pt;"> </span><span style="box-sizing: border-box; letter-spacing: 0pt; text-indent: -19.4pt; font-family: David; font-size: 12pt;">아래와 같이 공고함</span><span style="box-sizing: border-box; letter-spacing: 0pt; text-indent: -19.4pt; font-family: David; font-size: 12pt;">.</span></p> <p style="box-sizing: border-box; margin: 0pt 0pt 0pt 19.4pt; padding: 0px; word-break: keep-all; text-align: justify; vertical-align: baseline; font-family: 함초롬바탕; letter-spacing: 0pt; line-height: 31.2px; text-indent: -19.4pt; font-size: 13pt;"><span style="font-family: David; font-size: 12pt;"> </span></p> <p style="box-sizing: border-box; margin: 0pt 0pt 0pt 19.4pt; padding: 0px; word-break: keep-all; text-align: justify; vertical-align: baseline; font-family: 함초롬바탕; letter-spacing: 0pt; font-size: 10pt; line-height: 24px; text-indent: -19.4pt;"><span style="box-sizing: border-box; font-family: David; letter-spacing: 0pt; font-weight: bold; font-size: 12pt;">1. </span><span style="box-sizing: border-box; font-family: David; font-weight: bold; font-size: 12pt;">전반적인 요구사항</span></p> <p style="box-sizing: border-box; margin: 0pt 0pt 0pt 19.4pt; padding: 0px; word-break: keep-all; text-align: justify; vertical-align: baseline; font-family: 함초롬바탕; letter-spacing: 0pt; font-size: 10pt; line-height: 24px; text-indent: -19.4pt;"><span style="box-sizing: border-box; letter-spacing: 0pt; text-indent: -47.2pt; font-family: David; font-size: 12pt;">(1) </span><span style="box-sizing: border-box; text-indent: -47.2pt; font-family: David; letter-spacing: -0.1pt; font-size: 12pt;">원료의약품은 의약품 관리법에 따라 등록</span><span style="box-sizing: border-box; text-indent: -47.2pt; font-family: David; letter-spacing: -0.1pt; font-size: 12pt;">, </span><span style="box-sizing: border-box; text-indent: -47.2pt; font-family: David; letter-spacing: -0.1pt; font-size: 12pt;">추가 신청 및 재등록 </span><span style="box-sizing: border-box; text-indent: -47.2pt; font-family: David; letter-spacing: 0.1pt; font-size: 12pt;">신청 절차는 행정 허가 항목에 속하여 의약품 규제 당국은 </span><span style="box-sizing: border-box; text-indent: -47.2pt; font-family: David; letter-spacing: -0.1pt; font-size: 12pt;"><</span><span style="box-sizing: border-box; text-indent: -47.2pt; font-family: David; letter-spacing: -0.1pt; font-size: 12pt;">의</span><span style="box-sizing: border-box; text-indent: -47.2pt; font-family: David; letter-spacing: -0.2pt; font-size: 12pt;">약품 관리법</span><span style="box-sizing: border-box; text-indent: -47.2pt; font-family: David; letter-spacing: -0.2pt; font-size: 12pt;">>, <</span><span style="box-sizing: border-box; text-indent: -47.2pt; font-family: David; letter-spacing: -0.2pt; font-size: 12pt;">의약품 관리법 시행규칙</span><span style="box-sizing: border-box; text-indent: -47.2pt; font-family: David; letter-spacing: -0.2pt; font-size: 12pt;">>, <</span><span style="box-sizing: border-box; text-indent: -47.2pt; font-family: David; letter-spacing: -0.2pt; font-size: 12pt;">의약품 등록 </span><span style="box-sizing: border-box; letter-spacing: 0pt; text-indent: -47.2pt; font-family: David; font-size: 12pt;">및 관리 방법</span><span style="box-sizing: border-box; letter-spacing: 0pt; text-indent: -47.2pt; font-family: David; font-size: 12pt;">> </span><span style="box-sizing: border-box; letter-spacing: 0pt; text-indent: -47.2pt; font-family: David; font-size: 12pt;">등 관련 규정에 따라 검토하고 심사를 통해 최종 </span><span style="box-sizing: border-box; text-indent: -47.2pt; font-family: David; letter-spacing: 0.3pt; font-size: 12pt;">승인함</span><span style="box-sizing: border-box; text-indent: -47.2pt; font-family: David; letter-spacing: 0.3pt; font-size: 12pt;">. </span><span style="box-sizing: border-box; text-indent: -47.2pt; font-family: David; letter-spacing: 0.3pt; font-size: 12pt;">국내에서 생산한 원료의약품을 등록하는 자는 원료의</span><span style="box-sizing: border-box; letter-spacing: 0pt; text-indent: -47.2pt; font-family: David; font-size: 12pt;">약품을 실제 생산하는 기업이어야 하며</span><span style="box-sizing: border-box; letter-spacing: 0pt; text-indent: -47.2pt; font-family: David; font-size: 12pt;">, </span><span style="box-sizing: border-box; letter-spacing: 0pt; text-indent: -47.2pt; font-family: David; font-size: 12pt;">해외에서 생산하는 </span><span style="box-sizing: border-box; text-indent: -47.2pt; font-family: David; letter-spacing: -0.2pt; font-size: 12pt;">원료의약품을 등록하는 자는 중국 내 법인 기업에 위탁 후 등</span><span style="box-sizing: border-box; text-indent: -47.2pt; font-family: David; letter-spacing: -0.5pt; font-size: 12pt;">록</span><span style="box-sizing: border-box; letter-spacing: 0pt; text-indent: -47.2pt; font-family: David; font-size: 12pt;">해야 함</span></p> <p><span style="font-size: 12pt; font-family: David;"><br></span></p> <p><span style="font-size: 12pt; font-family: David;">▷ 자세한 내용은 출처 홈페이지를 참조하시기 바랍니다. </span></p> <div><br></div>
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