Templates - DCP (AR/Comments)
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Non Clinical / Clinical AR for Generics - MRP & DCP ( December 2017)
D70 Preliminary AR
Overview (July 2020)
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
Overview(July 2020)
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)