as of 2018 - 12 - 03

21.C Marketing authorisation documentation for active substances

21.C Marketing authorisation documentation for active substances
Here you will find answers to the following questions:

What are EDMF/ASMF and/or CEP?

What part do EDMF/ASMF and CEP play in documenting marketing authorisations?

What role does the manufacturer or the marketing authorisation holder of an active substance play in an EDMF/ASMF and/or CEP?

What safeguards do EDMF/ASMF and/or CEP offer with regard to GMP-compliant manufacturing?

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