총 409페이지

마. 동물용의약품등 품목허가(신고) 사항의 변경 ··························································116
바. 한국동물약품협회 신고 품목 ····················································································120
3. 동물용의약품(외품) 제조의 위탁·수탁 ·····························································121
가. 위·수탁 제조의 범위 ·······························································································121
나. 위·수탁 제조품목의 품목허가·신고(변경) ································································122
4. 동물용의약품 재평가 ························································································127
가. 재평가의 목적············································································································127
나. 실시절차 ···················································································································127
다. 재평가 대상품목(‘21 ∼‘28년) ················································································142
5. 신약등 재심사 ··································································································160
가. 재심사의 목적 ··········································································································160
나. 재심사 기간, 대상 및 조사 대상 동물 수 ······························································160
다. 재심사 절차 ··············································································································162
라. 재심사 관련 기타 참고 사항 ···················································································166
6. 동물용의약품의 제조 및 품질관리(GMP) ·······················································175
가. 목적 및 적용범위·······································································································175
나. 일반제제(화학제제)의 GMP 평가··············································································176
다. 생물학적제제등의 GMP 평가····················································································183
라. 사후관리 ···················································································································185
7. 제조업자 ? 제조(수입)품목 지위승계 ? 양도(양수)············································187
가. 공통사항 ···················································································································187
나. 품목 지위승계 이후 변경신청 등 ············································································189
다. 기타 ··························································································································19

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