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Information for Applicants: Guidelines: Generics

Generics

For new dossiers submitted from 1 March 2011 onwards, it is mandatory that the completed QIS/QOS templates be provided with the dossier(s). The applicant is encouraged to submit these templates before this, whenever possible.

For new dossiers submitted from 1 September 2011 onwards, it is mandatory that the dossier(s) be presented in CTD format.  The applicant is encouraged to submit in CTD format before this, whenever possible.

 

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