Full dossier sent by API manufacturer to National Authorities;
Applicant’s part sent by API manufacturer to MA applicant or holder of medicinal product;
Letter of access (to be sent by API manufacturer)
Assessment of ASMF by each national authority in the context of assessing a specific marketing authorization application or variation for medicinal products
Full dossier sent directly by manufacturer to EDQM;
Single evaluation centralised at EDQM;
By assessors nominated by national authorities and approved by Certification Steering Committee;
Independent from marketing authorization applications for medicinal products;
Certificate including annexes (additional tests to be performed) granted to manufacturer who supplies a copy of it to its customers (the users of the API/excipient)
原文由 闲鹤野云(ruojun) 发表: Applicant’s part sent by API manufacturer to MA applicant or holder of medicinal product 原料药生产商递交公开部分给药品上市许可申请人或持有人 “递交公开部分”我看不出这里有这层意思呢
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