EN PL

GMP: How to submit an Active Substance Master File?

23.01.2014
As part of the authorisation procedure for a medicinal product, applicants have to provide detailed information about the quality of the API. Generally, the applicant doesn\'t manufacture the API himself but receives it from an API manufacturer and has to submit the quality-related information regarding the API directly to the authority (see Directive 2001/83/EC, Annex I) in a separate document: the \"Active Substance Master File\".