Les dossiers confidentiels des substances actives à usage pharmaceutique correspondant a la procédure européenne "Active Substance Master file" (aussi appelée "European Drug Master File" ) sont déposés par les producteurs de ces substances dans le cadre :
Active Substance Master Files (ASMF) commonly known as European Drug Master Files (EDMF) corresponding to European Active Substance Master File procedure are submitted by the active substance manufacturer in relation to a marketing authorisation application or to a marketing authorisation variation.
They should be presented in accordance with the recommendations of the European note for guidance "Guideline on Active Substance Master File procedure"EMEA/CPMP/QWP/227/02 Rev3/Corr*.
- d'une demande d'autorisation de mise sur le marché
- ou d'une variation d'autorisation de mise sur le marché
Active Substance Master Files (ASMF) commonly known as European Drug Master Files (EDMF) corresponding to European Active Substance Master File procedure are submitted by the active substance manufacturer in relation to a marketing authorisation application or to a marketing authorisation variation.
They should be presented in accordance with the recommendations of the European note for guidance "Guideline on Active Substance Master File procedure"EMEA/CPMP/QWP/227/02 Rev3/Corr*.