Health Canada

The flu: approved drugs and medical devices in 2017.

Vaccines: approved drugs and medical devices in 2017.

This Notice of Compliance with Conditions Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada Guidance Document: Notice of Compliance with Conditions (NOC/c), is to advise you that information submitted in support of the New Drug Submission for Veklury (remdesivir), Control...

This Notice of Compliance with Conditions-Qualifying Notice (NOC/c-QN) is to advise you that information submitted in support of the New Drug Submission for Tepadina (thiotepa), control number 168816, for the indication in combination with other chemotherapeutic products as part of a high-dose...

This Notice of Compliance with Conditions Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada Guidance Document: Notice of Compliance with Conditions (NOC/c), is to advise you that information submitted in support of the New Drug Submission for Tepmetko (tepotinib), Control...

This Notice of Compliance with Conditions-Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada Guidance Document: Notice of Compliance with Conditions (NOC/c), is to advise you that information submitted in support of the New Drug Submission for Pemazyre (pemigatinib),...

This Notice of Compliance with Conditions Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada Guidance Document.

This Notice of Compliance with Conditions-Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada Guidance Document: Notice of Compliance with Conditions (NOC/c), is to advise you that information submitted in support of the New Drug Submission for Truseltiq (infigratinib...

This Notice of Compliance with Conditions Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada Guidance Document: Notice of Compliance with Conditions (NOC/c), is to advise you that information submitted in support of the Supplemental New Drug Submission for Zepzelca...

This Notice of Compliance with Conditions Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada Guidance Document: Notice of Compliance with Conditions (NOC/c), is to advise you that information submitted in support of the New Drug Submission for Gavreto (pralsetinib), Control...

This document includes guidance for companies (applicants) who wish to put forward submissions/applications to request a switch of an ingredient from prescription to non-prescription status.

This document includes guidance for companies (applicants) who wish to put forward submissions/applications to request a switch of an ingredient from prescription to non-prescription status.

This document includes guidance for companies (applicants) who wish to put forward submissions/applications to request a switch of an ingredient from prescription to non-prescription status.

This document includes guidance for companies (applicants) who wish to put forward submissions/applications to request a switch of an ingredient from prescription to non-prescription status.

The Prescription Drug List is a list of medicinal ingredients that when found in a drug, require a prescription. It does not include medicinal ingredients that when found in a drug, require a prescription if those ingredients are listed in Controlled Drugs and Substances Act Schedules.

The Food and Drugs Act (F&DA) and its regulations serve as a basis for the classification of drugs, devices, food, and cosmetics. The definitions of "food," "drug," "cosmetic" and "device" in section 2 of the F&DA, and the definition of "natural health product" (NHP) in section 1 of the...

This guidance document describes Health Canada’s expectations for distributing information about a prescription drug product using an electronic platform linked to that product’s label.

The legal framework that governs the use of electronic media in prescription drug labelling includes: the Food and Drugs Act (FDA), the Food and Drug Regulations (FDR), and certain provisions of the Controlled Drugs and Substances Act (CDSA) and its Regulations for prescription drugs containing...

You can make the initial request to incorporate a link to an electronic platform on a prescription drug label through existing submission pathways including a prescription drug's: initial application for market authorization ((A)NDS or DINA/DINB) and the post-market application procedure (S(A)NDS...

These guidelines are intended to help you comply with federal laws and to ensure that universally recognized principles, such as patient safety and accessibility, are respected when distributing information through an electronic platform linked to a prescription drug label.