drug specifications 中文意思是什麼
drug specifications
解釋
藥品規格- drug : n 1 藥，藥品，藥物，藥劑。2 〈俚語〉麻醉藥品，麻醉劑，使人上癮的毒品 （＝narcotic drugs）。3 〈pl...
- specifications : 標準
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Applicant should make applications for the following additional items when applying for the re - registration of imported drugs and modify packaging, labels and specifications types in accordance with sfda ' s requirements for drug packaging, labeling and specifications : ( 1 ) the changes of company names and addresses, of factory names, and of drug names other contents not relating to technical evaluation ; ( 2 ) supplements to or improvements on the security levels of specifications ; and ( 3 ) reductions in the validity of drugs
在申請進口藥品再注冊的同時申報下列補充申請，並按照我局有關藥品包裝、標簽和說明書的管理規定，需要修改包裝、標簽和說明書的品種：公司名稱和地址變更、生產廠的名稱變更、藥品名稱變更等無技術審評內容的；增加或者完善說明書安全性內容的；縮短藥品有效期的。 -
The name of the drug, its specifications, the producing unit, approval number, product batch number, principal ingredients, diseases for which it is indicated, manner of use, side - effects and points to note must be clearly set out on the label or in the instruction booklet
標簽或說明書上必須註明藥品的品名、規格、生產企業、批準文號、產品批號、主要成份、適應癥、用法、用量、禁忌、不良反應和注意事項。
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