Open Government Portal
This document includes guidance for companies (applicants) who wish to put forward submissions/applications to request a switch of an ingredient …
The Prescription Drug List is a list of medicinal ingredients that when found in a drug, require a prescription. It …
The Food and Drugs Act (F&DA) and its regulations serve as a basis for the classification of drugs, devices, food, …
This guidance document describes Health Canada’s expectations for distributing information about a prescription drug product using an electronic platform linked …
The legal framework that governs the use of electronic media in prescription drug labelling includes: the Food and Drugs Act …
You can make the initial request to incorporate a link to an electronic platform on a prescription drug label through …
These guidelines are intended to help you comply with federal laws and to ensure that universally recognized principles, such as …
This is a technical document that provides instructions on how to implement the ICH Electronic Common Technical Document v4.0 (eCTD …
The objective of this Ministerial Order is to ensure that Health Canada is able to review all applications for new …
Health Canada considers cybersecurity a component of the medical device's design and lifecycle that can affect the safety and effectiveness …