INNOK-식의약 GMP,인허가 컨설팅





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저희 이노케이는 GMP 전문 에이전시로 의약품등 해외제조소 등록 및 계속적인 규제기관 보고를 대행해드립니다

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작성자 innok 연락처 :
댓글 2건 조회 1,373회 작성일 22-06-16 06:29

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< 의약품등 해외제조소 등록제 안내 >


2020. 12. 12.부터 해외제조소 등록제가 본격 시행되었습니다.
등록없이 수입 가능하던 '19. 12. 12. 이전 수입허가(신고) 품목에 대한 유예기간이 '20. 12. 11.자로 종료되어 이후 모든 의약품등은 수입 전에 해외제조소를 등록해야 합니다.
등록대상: 수입품목 허가(신고)된 의약품(등록대상 원료의약품 포함)과 의약외품의 해외제조소
신청자: 의약품등 수입자
관련 법령: ● 「약사법」 제42조제7항 및 제8항 ● 「의약품 등의 안전에 관한 규칙」(총리령) 제60조의2 및 [별지 제57호의2 서식]

해외제조소 등록에 관한 고시가 제정되었습니다.
「의약품 등의 해외제조소 등록에 관한 규정」(식약처 고시) 제정('20. 9. 21.)
● 수입품목 허가(신고) 진행 중인 경우에도 해외제조소 등록 신청 가능(제2조제2항)
● 제조소 총람은 한글과 원문을 제출하여야 하며, 필요한 경우 영어로 제출 가능(제2조제3항)
● 제조소 총람은 해외제조소가 직접 식약처장에게 제출 가능(제2조제4항)
● 변경신고사항은 최초 등록일의 전월 말일부터 역산하여 1년 동안의 변경 내용을 매년 등록일이 속하는 월의 말일까지 제출(제2조)
* 예) '20년 10월에 등록했을 경우 1년 동안의 변경내용을 '21년 10월 31.까지 제출

해외제조소, 무엇을 등록해야 하나요?
해외제조소 정보: 제조소의 명칭, 소재지, 관리자, 연락처(전화번호, 전자우편주소 등), 해외제조소의 인력·시설·제조·품질관리에 관한 요약 자료(이하 '제조소 총람')
* 「의약품 등의 안전에 관한 규칙」 제48조제9호 및 제9호의2에 해당하는 의약품등만 제출
품목 정보: 수입품목의 제품명, 종류(원료의약품, 의약외품 등), 제형, 허가(등록)번호 또는 신고수리번호

등록사항에 변경이 발생한 경우
「약사법」 제42조제8항에 따라 변경사항이 발생한 경우 변경등록 또는 변경신고하여야 합니다.
변경등록 사항: 다음 어느 하나에 해당하는 등록사항의 변경
● 해외제조소의 명칭 및 소재지(행정구역의 변경을 포함)
● 수입품목의 제품명, 종류(원료의약품, 의약외품 등), 제형, 허가(등록)번호 또는 신고수리번호
변경신고 사항: 변경등록 사항 외의 변경사항(해외제조소의 관리자, 연락처, 제조소 총람)

온라인 민원 시청
민원인(수입자)
의약품안전나라(https://nedrug.mfds.go.kr) 접속
▶ 전자민원/보고 메뉴에서 민원사무명 선택
* (등록) 의약품등 해외제조소 등록
(변경) 의약품등 해외제조소 등록사항 변경 > 변경등록 또는 변경신고 선택
▶ 민원신청서 작성
▶ 등록 신청
식약처(담당 부서)
민원 접수
▶신청사항 검토
* 처리기간 30일(보완 요구한 경우, 기간 연장)
▶ 처리 결과 알림

해외제조소 등록사항 온라인 확인
* 의약품안전나라(nedrug.mfds.go.kr) > 의약품등 정보 > '의약품등 해외제조소 등록 정보'에서 해외제조소 등록번호, 국가, 수입자명, 제조소 명칭, 제조소 소재지 확인 가능 

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