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47222 records

This document provides information on the application process and application contents for a disinfectant drug product regulated under the Food …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: applying for DIN DIN for disinfectant-drug COVID-19 pandemic purpose-and-eligible products

Types of products eligible in receiving a Drug Identification Number (DIN).

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: applying for DIN distribute sell hand sanitizer eligible products

Existing processes and guidance for manufacturers and sponsors applying for a Drug Identification Number (DIN) for hand sanitizers.

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: applying for DIN distribute sell hand sanitizer purpose and scope

This policy describes the requirements relating to the assignment of Drug Identification Numbers (DINs) for drug products sold in kits …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Drug Identification Numbers Assignment of DIN DIN for drug-products-in-kits

This document is intended to provide guidance with respect to the Quality (Chemistry and Manufacturing) portion of Applications for Drug …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: draft-guidance for industry quality guidance applications for DIN DINAs for pharmaceuticals

EDC 2022 Annual Report

Record Modified: Sep 2, 2023
Record Released: Aug 31, 2023
Publisher: Export Development Canada
Formats: HTML
Keywords: Annual Report Financial 2022

EDC 2020- 2021 Annual Report

Record Modified: Sep 2, 2023
Record Released: Aug 31, 2023
Publisher: Export Development Canada
Formats: HTML
Keywords: Annual Report Financial 2020 2021

If a submission or application is not reviewed within the established performance standard, sponsors will be credited 25% of the …

Record Modified: Sep 1, 2023
Record Released: Aug 30, 2023
Publisher: Health Canada
Formats: HTML
Keywords: drug submissions-and-applications human-drugs-and-disinfectants submission guidance-document on fees fees for review evaluation fees credit-for missed performance-standard

Health Canada uses disaggregated data to analyze the safety and efficacy of health products. The collection and analysis of disaggregated …

Record Modified: Sep 1, 2023
Record Released: Aug 30, 2023
Publisher: Health Canada
Formats: HTML
Keywords: drug submissions disaggregated data analysis of disaggregated-data questionnaire for drug-submissions safety-and-efficacy of health-products clinical-trials diversity of clinical-trial

This document is intended to provide guidance with regard to the Quality [that is (i.e.), Chemistry and Manufacturing] portion of …

Record Modified: Sep 1, 2023
Record Released: Aug 30, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Quality Guidance chemistry and manufacturing New Drug Submissions NDSs Abbreviated New-Drug Submissions ANDSs substances of synthetic semi-synthetic origin drug products Division C.08 Food-and-Drug Regulations