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Drug products legislation and guidelines
Federal

Acts and regulations, Health Canada guidance documents and policies related to pharmaceutical drugs and medical devices. The Pharmaceutical Drugs Directorate …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: drug products legislation Food-and-Drug Regulations Food-and-Drugs Act interim orders notices canada gazette memorandum of understanding schedule f guidance documents policies pharmaceutical drugs safe ...
Fact Sheets – Drug products
Federal

List of Health Canada information sheets covering topics related to drug products.

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: fact sheets information sheets drug products prescription drugs prescription medicines pharmaceutical products
Fact Sheets – Medical devices
Federal

Health Canada fact sheets related to medical devices.

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: fact sheets medical devices
Fees for human drugs
Federal

Fees for regulatory activities related to human drugs (pharmaceutical and biological) are charged as per the Fees in Respect of …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: human drugs fees fees for regulatory-activities fees for human-drugs pharmaceutical-and-biological drugs drugs-and-medical-devices order
Guidance Document Post-Drug Identification Number (DIN) Changes
Federal

The guidance is intended to advise both internal and external stakeholders regarding the filing requirements for post market changes and …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document post-drug identification number DIN Changes post market changes filing requirements
Summary - Cancellation of a Drug Identification Number (DIN) and Notification of …
Federal

This guidance document provides information on the regulatory requirements for when: a drug is not sold for 12 or more …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Cancellation of DIN notification of discontinuation-of-sales
Summary: Guidance Document - Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals …
Federal

Drug Identification Numbers for Schedule C Drugs.

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document drug DIN DIN for Schedule-C-Drugs radiopharmaceuticals and kits
Applying for a Drug Identification Number (DIN) for a disinfectant drug during …
Federal

General COVID-19 flexibilities for all disinfectant application/submission pathways.

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 application flexibilities COVID-19 flexibilities disinfectant application/submission
Applying for a Drug Identification Number (DIN) for a disinfectant drug during …
Federal

Steps to select the applicable fee category, the proper application stream and the pathways used to seek an authorization for …

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 application stream applicable fee category proper application stream authorization for disinfectant-product
Applying for a Drug Identification Number (DIN) for a disinfectant drug during …
Federal

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