Certification procedure
Certification procedure
Certification procedure
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Differences between CEP & ASMF<br />
- Specificity of ASMF:<br />
• Full dossier sent by API manufacturer to National Authorities<br />
• Applicant’s part sent by API manufacturer to MA applicant or<br />
holder of medicinal Product<br />
• Letter of access (to be sent by API manufacturer)<br />
• Assessment of ASMF by each national authority in the<br />
context of assessing a specific marketing authorisation<br />
application or variation for medicinal products<br />
Andrew McMath 29/01/10 ©2010 EDQM, Council of Europe, All rights reserved