협회공지 Association 공지사항 협회소식,회원동정 교육정보 회원가입

HOME > 협회소개 > 공지사항 글답변 · 이름 · 패스워드 · 이메일 · 홈페이지 · 옵션 html · 제목 · 내용 <p><span style="color: rgb(102, 102, 102); margin: 0px; padding: 0px; border: none; font-family: 돋움; letter-spacing: 0pt; font-size: 12pt;">1. </span><span style="color: rgb(102, 102, 102); margin: 0px; padding: 0px; border: none; font-family: 돋움; font-size: 12pt;">개정이유</span></p><br style="color: rgb(102, 102, 102); font-family: " nanum="" gothic",="" 나눔고딕,="" nanumgothic,="" "맑은="" 고딕",="" "malgun="" 돋움,="" dotum,="" sans-serif;="" font-size:="" 15px;="" background-color:="" rgb(255,="" 255,="" 255);"=""><p class="1" style="border: none; color: rgb(102, 102, 102); font-family: " nanum="" gothic",="" 나눔고딕,="" nanumgothic,="" "맑은="" 고딕",="" "malgun="" 돋움,="" dotum,="" sans-serif;="" font-size:="" 15px;="" background-color:="" rgb(255,="" 255,="" 255);"=""><span style="margin: 0px; padding: 0px; border: none; font-size: 12pt; font-family: 돋움;"></span><span style="margin: 0px; padding: 0px; border: none; font-family: 돋움; font-size: 12pt;">한약</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 12pt; font-family: 돋움;">(</span><span style="margin: 0px; padding: 0px; border: none; font-family: 돋움; font-size: 12pt;">생약</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 12pt; font-family: 돋움;">)</span><span style="margin: 0px; padding: 0px; border: none; font-family: 돋움; font-size: 12pt;">제제 전문의약품 복합제의 제품명에서 주성분명 기재 원칙을 삭제하고</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 12pt; font-family: 돋움;">, </span><span style="margin: 0px; padding: 0px; border: none; font-family: 돋움; font-size: 12pt;">한약재의 포장단위 기재 방법을 명확히 하는 등 현행 제도 운영상 나타난 미비점을 보완·</span><span style="margin: 0px; padding: 0px; border: none; font-family: 돋움; font-size: 12pt;">개선하여 품목허가·</span><span style="margin: 0px; padding: 0px; border: none; font-family: 돋움; font-size: 12pt;">심사의 일관성을 확보하고자 함</span></p><br style="color: rgb(102, 102, 102); font-family: " nanum="" gothic",="" 나눔고딕,="" nanumgothic,="" "맑은="" 고딕",="" "malgun="" 돋움,="" dotum,="" sans-serif;="" font-size:="" 15px;="" background-color:="" rgb(255,="" 255,="" 255);"=""><p class="2" style="border: none; color: rgb(102, 102, 102); font-family: " nanum="" gothic",="" 나눔고딕,="" nanumgothic,="" "맑은="" 고딕",="" "malgun="" 돋움,="" dotum,="" sans-serif;="" font-size:="" 15px;="" background-color:="" rgb(255,="" 255,="" 255);"=""><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 12pt; font-family: 돋움;">2. </span><span style="margin: 0px; padding: 0px; border: none; font-family: 돋움; font-size: 12pt;">주요내용</span></p><br style="color: rgb(102, 102, 102); font-family: " nanum="" gothic",="" 나눔고딕,="" nanumgothic,="" "맑은="" 고딕",="" "malgun="" 돋움,="" dotum,="" sans-serif;="" font-size:="" 15px;="" background-color:="" rgb(255,="" 255,="" 255);"=""><p class="2" style="margin-left: 32px; border: none; color: rgb(102, 102, 102); font-family: " nanum="" gothic",="" 나눔고딕,="" nanumgothic,="" "맑은="" 고딕",="" "malgun="" 돋움,="" dotum,="" sans-serif;="" font-size:="" 15px;="" background-color:="" rgb(255,="" 255,="" 255);="" text-indent:="" -24.4pt;"=""><span style="margin: 0px; padding: 0px; border: none; font-size: 12pt; font-family: 돋움;"></span><span style="margin: 0px; padding: 0px; border: none; font-family: 돋움; font-size: 12pt;">가</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: 0pt; font-size: 12pt; font-family: 돋움;">. </span><span style="margin: 0px; padding: 0px; border: none; font-family: 돋움; font-size: 12pt;">전문의약품 복합제의 제품명에서 주성분명 기재 원칙을 삭제함</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: -0.3pt; font-size: 12pt; font-family: 돋움;">(</span><span style="margin: 0px; padding: 0px; border: none; font-family: 돋움; letter-spacing: -0.3pt; font-size: 12pt;">안 제</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: -0.3pt; font-size: 12pt; font-family: 돋움;">10</span><span style="margin: 0px; padding: 0px; border: none; font-family: 돋움; letter-spacing: -0.3pt; font-size: 12pt;">조</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: -0.3pt; font-size: 12pt; font-family: 돋움;">)</span></p><br style="color: rgb(102, 102, 102); font-family: " nanum="" gothic",="" 나눔고딕,="" nanumgothic,="" "맑은="" 고딕",="" "malgun="" 돋움,="" dotum,="" sans-serif;="" font-size:="" 15px;="" background-color:="" rgb(255,="" 255,="" 255);"=""><p class="3" style="margin-left: 31px; border: none; color: rgb(102, 102, 102); font-family: " nanum="" gothic",="" 나눔고딕,="" nanumgothic,="" "맑은="" 고딕",="" "malgun="" 돋움,="" dotum,="" sans-serif;="" font-size:="" 15px;="" background-color:="" rgb(255,="" 255,="" 255);="" text-indent:="" -23.9pt;"=""><span style="margin: 0px; padding: 0px; border: none; letter-spacing: -0.2pt; font-size: 12pt; font-family: 돋움;"></span><span style="margin: 0px; padding: 0px; border: none; font-family: 돋움; letter-spacing: -0.2pt; font-size: 12pt;">나</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: -0.2pt; font-size: 12pt; font-family: 돋움;">. </span><span style="margin: 0px; padding: 0px; border: none; font-family: 돋움; letter-spacing: -0.2pt; font-size: 12pt;">한약재의 포장단위를 자사 포장단위로 기재할 수 있도록 명확히 규정함</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: -0.2pt; font-size: 12pt; font-family: 돋움;">(</span><span style="margin: 0px; padding: 0px; border: none; font-family: 돋움; letter-spacing: -0.2pt; font-size: 12pt;">안 제</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: -0.2pt; font-size: 12pt; font-family: 돋움;">18</span><span style="margin: 0px; padding: 0px; border: none; font-family: 돋움; letter-spacing: -0.2pt; font-size: 12pt;">조</span><span style="margin: 0px; padding: 0px; border: none; letter-spacing: -0.2pt; font-size: 12pt; font-family: 돋움;">)</span></p><br style="color: rgb(102, 102, 102); font-family: " nanum="" gothic",="" 나눔고딕,="" nanumgothic,="" "맑은="" 고딕",="" "malgun="" 돋움,="" dotum,="" sans-serif;="" font-size:="" 15px;="" background-color:="" rgb(255,="" 255,="" 255);"=""><p class="3" style="margin-left: 31px; border: none; color: rgb(102, 102, 102); font-family: " nanum="" gothic",="" 나눔고딕,="" nanumgothic,="" "맑은="" 고딕",="" "malgun="" 돋움,="" dotum,="" sans-serif;="" font-size:="" 15px;="" background-color:="" rgb(255,="" 255,="" 255);="" text-indent:="" -23.9pt;"=""><span style="margin: 0px; padding: 0px; border: none; letter-spacing: -0.2pt; font-size: 12pt; font-family: 돋움;"></span></p><p><span style="color: rgb(102, 102, 102); text-indent: -23.9pt; margin: 0px; padding: 0px; border: none; font-family: 돋움; letter-spacing: -0.2pt; font-size: 12pt;">다</span><span style="color: rgb(102, 102, 102); text-indent: -23.9pt; margin: 0px; padding: 0px; border: none; letter-spacing: -0.2pt; font-size: 12pt; font-family: 돋움;">. </span><span style="color: rgb(102, 102, 102); text-indent: -23.9pt; margin: 0px; padding: 0px; border: none; font-family: 돋움; letter-spacing: -0.2pt; font-size: 12pt;">인용하고 있는 법령 등의 제명 및 조문 이동 등의 변경사항을 반영함</span><span style="color: rgb(102, 102, 102); text-indent: -23.9pt; margin: 0px; padding: 0px; border: none; letter-spacing: -0.2pt; font-size: 12pt; font-family: 돋움;">(</span><span style="color: rgb(102, 102, 102); text-indent: -23.9pt; margin: 0px; padding: 0px; border: none; font-family: 돋움; letter-spacing: -0.2pt; font-size: 12pt;">안 제</span><span style="color: rgb(102, 102, 102); text-indent: -23.9pt; margin: 0px; padding: 0px; border: none; letter-spacing: -0.2pt; font-size: 12pt; font-family: 돋움;">5</span><span style="color: rgb(102, 102, 102); text-indent: -23.9pt; margin: 0px; padding: 0px; border: none; font-family: 돋움; letter-spacing: -0.2pt; font-size: 12pt;">조 등</span><span style="color: rgb(102, 102, 102); text-indent: -23.9pt; margin: 0px; padding: 0px; border: none; letter-spacing: -0.2pt; font-size: 12pt; font-family: 돋움;">)</span> </p><p><span style="color: rgb(102, 102, 102); text-indent: -23.9pt; margin: 0px; padding: 0px; border: none; letter-spacing: -0.2pt; font-size: 12pt; font-family: 돋움;"> </span></p><p><span style="color: rgb(102, 102, 102); text-indent: -23.9pt; margin: 0px; padding: 0px; border: none; letter-spacing: -0.2pt; font-size: 12pt; font-family: 돋움;">개정고시문은 식약처 홈페이지 (<a href="http://www.mfds.go.kr>">www.mfds.go.kr></a> 법령자료> 제개정고시 등)에 게재되어 있습니다. </span></p><p><span style="color: rgb(102, 102, 102); text-indent: -23.9pt; margin: 0px; padding: 0px; border: none; letter-spacing: -0.2pt; font-size: 12pt; font-family: 돋움;">(게시글 상단 링크 클릭하면 바로 이동합니다.) </span></p> 임시저장 · 링크 #1 · 링크 #2 · 파일 + - · 자동등록방지 자동등록방지 숫자음성듣기 새로고침 자동등록방지 숫자를 순서대로 입력하세요.   글저장  목록