Templates - DCP (AR/Comments)

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Non Clinical / Clinical AR for Generics - MRP & DCP ( December 2017)

D70 Preliminary AR

        D70 Overview AR Template (empty) (May 2022)

        Overview AR Template (including instructions) (May 2022)

        Quality (January 2017)

        Non-clinical (October 2016)

        Clinical (January 2017)

D100 CMS Comments (November 2018)

D105 clock stop (March 2012)

Applicant's response template (February 2022)

D120 Draft AR

        Non-clinical (October 2016)

        Clinical (October 2016)

D120/D180 Quality AR (December 2018)

D145 CMS comments (December 2018)

D205 CMS Comments (December 2018)

RMS Assessment Report on Similarity (July 2020)

End of procedure(January 2022)