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Home - Information for Applicants: Guidelines: Generics

Information for Applicants: Guidelines: Generics

Generics

Introduction to the new Quality guideline
- Preparation of Product Dossiers (PDS) in Common Technical Document (CTD) Format [pdf]
- Guidelines on Submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part [pdf]

Templates (Quality) - the filled-out templates should be submitted in Word format!
- Quality Overall Summary - Product Dossier (QOS-PD) [doc]
- Quality Information Summary (QIS) [doc]

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.

Template (BE) - the filled-out template should be submitted in Word format!
- Presentation of Bioequivalence Trial Information (BTIF) [doc]