<p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; text-size-adjust: none;"><span style="color: rgb(118, 123, 134); font-family: Malgun Gothic; box-sizing: inherit; text-size-adjust: none;"><span style="font-size: 11pt; box-sizing: inherit; text-size-adjust: none;">식품의약품안전처 식품의약품안전평가원 바이오생약심사부 생물제제과에서</span></span></p> <p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; text-size-adjust: none;"><span style="color: rgb(118, 123, 134); font-family: Malgun Gothic; box-sizing: inherit; text-size-adjust: none;"><span style="font-size: 11pt; box-sizing: inherit; text-size-adjust: none;">「백신제제의 위해성관리계획 작성방법 표준안」(2020.10.30.)을 마련하였습니다.</span></span></p> <p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; text-size-adjust: none;"><span style="color: rgb(118, 123, 134); font-family: Malgun Gothic; box-sizing: inherit; text-size-adjust: none;"><br style="box-sizing: inherit; text-size-adjust: none;"></span></p> <p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; text-size-adjust: none;"><span style="color: rgb(118, 123, 134); font-family: Malgun Gothic; box-sizing: inherit; text-size-adjust: none;"><span style="font-size: 11pt; box-sizing: inherit; text-size-adjust: none;">< 목 차 ></span><br style="box-sizing: inherit; text-size-adjust: none;"> <span style="font-size: 11pt; box-sizing: inherit; text-size-adjust: none;">Ⅰ. 서론</span><br style="box-sizing: inherit; text-size-adjust: none;"> <span style="font-size: 11pt; box-sizing: inherit; text-size-adjust: none;">  1. 목적 및 배경</span><br style="box-sizing: inherit; text-size-adjust: none;"> <span style="font-size: 11pt; box-sizing: inherit; text-size-adjust: none;">  2. 범위</span><br style="box-sizing: inherit; text-size-adjust: none;"> <span style="font-size: 11pt; box-sizing: inherit; text-size-adjust: none;">Ⅱ. 위해성관리계획서</span><br style="box-sizing: inherit; text-size-adjust: none;"> <span style="font-size: 11pt; box-sizing: inherit; text-size-adjust: none;">  A. 표지, 개요, 변경이력, 목차</span><br style="box-sizing: inherit; text-size-adjust: none;"> <span style="font-size: 11pt; box-sizing: inherit; text-size-adjust: none;">  B. 본문</span><br style="box-sizing: inherit; text-size-adjust: none;"> <span style="font-size: 11pt; box-sizing: inherit; text-size-adjust: none;">Ⅲ. 위해성관리계획 이행·평가 결과</span><br style="box-sizing: inherit; text-size-adjust: none;"> <span style="font-size: 11pt; box-sizing: inherit; text-size-adjust: none;">  A. 표지</span><br style="box-sizing: inherit; text-size-adjust: none;"> <span style="font-size: 11pt; box-sizing: inherit; text-size-adjust: none;">  B. 본문</span><br style="box-sizing: inherit; text-size-adjust: none;"> <span style="font-size: 11pt; box-sizing: inherit; text-size-adjust: none;">Ⅳ. 정기적 최신 안전성정보 보고서</span><br style="box-sizing: inherit; text-size-adjust: none;"> <span style="font-size: 11pt; box-sizing: inherit; text-size-adjust: none;">[붙임 1] 백신접종자용 사용설명서 작성양식</span><br style="box-sizing: inherit; text-size-adjust: none;"> <span style="font-size: 11pt; box-sizing: inherit; text-size-adjust: none;">[붙임 2] 의사 등 전문가용 설명자료 작성양식</span></span></p> <p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; text-size-adjust: none;"><span style="color: rgb(118, 123, 134); font-family: Malgun Gothic; box-sizing: inherit; text-size-adjust: none;"><br style="box-sizing: inherit; text-size-adjust: none;"></span></p> <p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; text-size-adjust: none;"><span style="color: rgb(118, 123, 134); font-family: Malgun Gothic; box-sizing: inherit; text-size-adjust: none;">※ 본 표준안은 백신제제의 위해성관리계획 작성 시 민원인의 편의를 돕고자 필요한 최소한의 기재사항을 예시로 제시한 것으로,</span></p> <p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; text-size-adjust: none;"><span style="color: rgb(118, 123, 134); font-family: Malgun Gothic; box-sizing: inherit; text-size-adjust: none;">   강제성이나 법적 효력을 가지고 있는 것은 아닙니다.</span></p> <p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; text-size-adjust: none;"><span style="color: rgb(118, 123, 134); font-family: Malgun Gothic; box-sizing: inherit; text-size-adjust: none;">※ 본 표준안 내용 이외에 각 백신제제의 특성을 반영하여 추가하거나 수정할 수 있으며 「의약품의 위해성관리계획 가이드라인</span></p> <p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; text-size-adjust: none;"><span style="color: rgb(118, 123, 134); font-family: Malgun Gothic; box-sizing: inherit; text-size-adjust: none;">   (민원인 안내서)」에 따라 작성할 수도 있습니다.</span></p> <p><br></p>
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