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Includes general details on the active substance, manufacturing processes, quality specifications, and analytical controls.

Contains information that the manufacturer is willing to share with the drug developer (the Marketing Authorization Holder). Download asmf 4349 zip

This part is sent directly to the National Competent Authorities or the EMA and is with the drug developer. Security Warning Download asmf 4349 zip

An is a set of confidential documents provided by a manufacturer to regulatory authorities (like the EMA ) to support a marketing authorization for a medicine. It allows a manufacturer to protect intellectual property while giving regulators necessary quality data. Typical Content Structure Download asmf 4349 zip