Streamlined Category B submissions. : H113-31/12-2023E-PDF

"The purpose of this new guidance document is to clarify the eligibility and conditions for acceptance of Streamlined Category B Submissions. With the publication of Regulatory Directive DIR2017-01, Management of Submissions Policy (8 March 2017), new terminology was introduced for submissions with a limited number of amendments, and requiring only a value assessment: Streamlined Category B Submissions. These types of submissions were formerly termed Category C Efficacy Reviews (REG2002-04). On 3 July 2020, in Regulatory Proposal PRO2020-01, the PMRA proposed to increase the number of label amendments permitted within one of these submissions to six (6). This guidance document is published pursuant to PRO2020-01 and replaces REG2002-04"--Page 1.

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publications.gc.ca/pub?id=9.955490&sl=1

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