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「의약품등 해외제조소 등록 질의 · 응답집(민원인 안내서)」 개정 알림

「의약품등 해외제조소 등록 질의 · 응답집(민원인 안내서)」 개정 알림 : 작성자, 작성일, 조회수, 출처,원문, 첨부파일 정보 제공
작성자	관리자
작성일	2022-07-22	조회수	1,093
출처	한국바이오의약품협회
원문	https://www.kobia.kr/bbs/board.php?tbl=data01&mode=VIEW&num=646&category=&findEx=&findType=&findWord=&sort1=&sort2=&it_id=&shop_flag=&mobile_flag=&page=1
첨부파일	220721_의약품등 해외제조소 등록 질의응답집(민원인 안내서)_개정.pdf(417.99KB)내려받기

한국바이오의약품협회에서 안내드립니다.

<식품의약품안전처 「의약품등 해외제조소 등록 질의 · 응답집(민원인 안내서)」 개정 알림>

우리 처에서는「약사법」제42조제7항 개정 규정의 시행( '22. 7. 21.)에 따라 자사 제조 원료의약품의 해외제조소 등록이 의무화됨에 따라, 원료의약품 수입업체 등의 이해 도 제고를 위해 「의약품등 해외제조소 등록 질의 · 응답집(민원인 안내서)」를 붙임 과 같이 개정하였음을 알려드립니다.

참고로 동 안내서는 우리 처 홈페이지(http://www.mfds.go.kr → 법령/자료 → 법령정보 → 공무원 지침서/민원인안내서)에서 열람하실 수 있음을 알려드립니다.

붙임. 「의약품등 해외제조소 등록 질의 · 응답집(민원인 안내서)」. 끝.

이전글 의약품등 임상시험실시기관 지정현황 공고(2022.07.19.)
다음글 WTO, 코로나19 백신 지재권 면제 결정

연관컨텐츠: 한국바이오의약품협회

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<p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: tahoma; font-size: 12pt;">한국바이오의약품</span><span style="box-sizing: inherit; text-size-adjust: none; font-family: tahoma; font-size: 12pt;">협회에서 안내드립니다.</span></p>
<p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: tahoma; font-size: 11pt;"><br style="box-sizing: inherit; text-size-adjust: none;"></span></p>
<p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><br style="box-sizing: inherit; text-size-adjust: none;"></p>
<p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: tahoma; font-size: 12pt;"><strong style="box-sizing: inherit; text-size-adjust: none;"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 14pt;"><span style="box-sizing: inherit; text-size-adjust: none;"><식품의약품안전처 </span><span style="box-sizing: inherit; text-size-adjust: none; color: rgb(81, 143, 187);">「의약품등 해외제조소 등록 질의 · 응답집(민원인 안내서)」 개정 알림</span><span style="box-sizing: inherit; text-size-adjust: none;">></span></span></strong></span></p>
<p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><br style="box-sizing: inherit; text-size-adjust: none;"></p>
<p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; color: rgb(0, 0, 0); font-family: 나눔고딕, NanumGothic, sans-serif; font-size: 16px; font-weight: inherit;"><br style="box-sizing: inherit; text-size-adjust: none;"></span></p>
<p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic, sans-serif; color: rgb(90, 80, 75);"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 16px;">우리 처에서는「약사법」제42조제7항 개정 규정의 시행( '22. 7. 21.)에 따라 자사 <b style="box-sizing: inherit; text-size-adjust: none;">제조 원료의약품의 해외제조소 등록이 의무화됨</b>에 따라, 원료의약품 수입업체 등의 이해 도 제고를 위해<b style="box-sizing: inherit; text-size-adjust: none;"> 「의약품등 해외제조소 등록 질의 · 응답집(민원인 안내서)」를 붙임 과 같이 개정</b>하였음을 알려드립니다.</span></span></p>
<p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic, sans-serif; color: rgb(90, 80, 75);"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 16px;"><br style="box-sizing: inherit; text-size-adjust: none;"></span></span></p>
<p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic, sans-serif; color: rgb(90, 80, 75);"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 16px;">참고로 동 안내서는 우리 처 홈페이지(<a href="http://www.mfds.go.kr/" target="_self" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">http://www.mfds.go.kr</a> → 법령/자료 → 법령정보 → <a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15049&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1" target="_self" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">공무원 지침서/민원인안내서</a>)에서 열람하실 수 있음을 알려드립니다.</span></span> </p>
<p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic, sans-serif; color: rgb(90, 80, 75);"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 16px;"><br style="box-sizing: inherit; text-size-adjust: none;"></span></span></p>
<p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><br style="box-sizing: inherit; text-size-adjust: none;"></p>
<p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic, sans-serif;"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 16px; color: rgb(0, 0, 0);">붙임. </span></span><span style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic, sans-serif;"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 16px;">「의약품등 해외제조소 등록 질의 · 응답집(민원인 안내서)」.  끝.</span></span></p>
<p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic, sans-serif;"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 16px;"><br></span></span></p>

<p><br></p> <p><br></p> <p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: tahoma; font-size: 12pt;">한국바이오의약품</span><span style="box-sizing: inherit; text-size-adjust: none; font-family: tahoma; font-size: 12pt;">협회에서 안내드립니다.</span></p> <p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: tahoma; font-size: 11pt;"><br style="box-sizing: inherit; text-size-adjust: none;"></span></p> <p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><br style="box-sizing: inherit; text-size-adjust: none;"></p> <p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: tahoma; font-size: 12pt;"><strong style="box-sizing: inherit; text-size-adjust: none;"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 14pt;"><span style="box-sizing: inherit; text-size-adjust: none;"><식품의약품안전처 </span><span style="box-sizing: inherit; text-size-adjust: none; color: rgb(81, 143, 187);">「의약품등 해외제조소 등록 질의 · 응답집(민원인 안내서)」 개정 알림</span><span style="box-sizing: inherit; text-size-adjust: none;">></span></span></strong></span></p> <p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><br style="box-sizing: inherit; text-size-adjust: none;"></p> <p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; color: rgb(0, 0, 0); font-family: 나눔고딕, NanumGothic, sans-serif; font-size: 16px; font-weight: inherit;"><br style="box-sizing: inherit; text-size-adjust: none;"></span></p> <p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic, sans-serif; color: rgb(90, 80, 75);"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 16px;">우리 처에서는「약사법」제42조제7항 개정 규정의 시행( '22. 7. 21.)에 따라 자사 <b style="box-sizing: inherit; text-size-adjust: none;">제조 원료의약품의 해외제조소 등록이 의무화됨</b>에 따라, 원료의약품 수입업체 등의 이해 도 제고를 위해<b style="box-sizing: inherit; text-size-adjust: none;"> 「의약품등 해외제조소 등록 질의 · 응답집(민원인 안내서)」를 붙임 과 같이 개정</b>하였음을 알려드립니다.</span></span></p> <p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic, sans-serif; color: rgb(90, 80, 75);"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 16px;"><br style="box-sizing: inherit; text-size-adjust: none;"></span></span></p> <p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic, sans-serif; color: rgb(90, 80, 75);"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 16px;">참고로 동 안내서는 우리 처 홈페이지(<a href="http://www.mfds.go.kr/" target="_self" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">http://www.mfds.go.kr</a> → 법령/자료 → 법령정보 → <a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15049&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1" target="_self" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">공무원 지침서/민원인안내서</a>)에서 열람하실 수 있음을 알려드립니다.</span></span> </p> <p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic, sans-serif; color: rgb(90, 80, 75);"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 16px;"><br style="box-sizing: inherit; text-size-adjust: none;"></span></span></p> <p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><br style="box-sizing: inherit; text-size-adjust: none;"></p> <p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic, sans-serif;"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 16px; color: rgb(0, 0, 0);">붙임. </span></span><span style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic, sans-serif;"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 16px;">「의약품등 해외제조소 등록 질의 · 응답집(민원인 안내서)」. 끝.</span></span></p> <p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic, sans-serif;"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 16px;"><br></span></span></p>
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