Open Government Portal

Found 10 records similar to Guidance Document: Schedule A and Section 3 to the Food and Drugs Act [Health Canada, 2010]

Federal

In Canada, natural health products and foods are regulated under the Food and Drugs Act (FDA) and its associated regulations. Products that meet the definition of a "natural health product" (NHP) as set out in the Natural Health Products Regulations (NHPR) are subject to the FDA as it applies to drugs and to the NHPR. Products that are foods as defined in the FDA are subject to the FDA as it applies to foods and to Parts A, B and D of the Food and Drug Regulations (FDR). It is important to note that the provisions of the FDR do not apply to products classified as NHPs except where such provisions are incorporated by reference into the NHPR, as per section 3 of the NHPR.

Last Updated: Sep. 9, 2021
Date Published: Mar. 27, 2018
Organization: Health Canada
Formats: HTML
Keywords:  NHP, natural health products, foods, classification of products, food-natural health product interface, products in food formats, Food and Drugs Act, FDA, Parts A
Federal

On December 13, 2017, Health Canada published the Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs in Dosage Form Listed in Schedule C to the Food and Drugs Act) in Canada Gazette, Part II. The objective of this regulatory amendment is to apply to Schedule C Drugs (radiopharmaceuticals and kits), the requirement to have a Drug Identification Number (DIN) in order for a drug to be sold in Canada. Along with the new requirement for all Schedule C drugs to have a DIN, the labelling requirements have also been updated to reflect the new requirement: instead of requiring the Establishment Licence number to be on the label, there will now be a requirement for the DIN to be on the label.

Last Updated: Jul. 6, 2021
Date Published: May 5, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, DIN, drug identification numbers, schedule C drugs, radiopharmaceuticals and Kits, regulatory amendment, Food and Drug Regulations, drugs in dosage form, the requirement
Federal

This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations. These new drugs may include pharmaceuticals, biologics, and radiopharmaceuticals for human use, including those submissions for which a NOC has been recommended but issuance of the NOC has been placed on hold.

Last Updated: Jul. 7, 2021
Date Published: Apr. 1, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, post-notice of compliance, NOC Changes, changes to new drugs, safety and efficacy document, pharmaceutical, biologic, radiopharmaceutical, drugs for human use
Federal

This document provides information for industry on how Health Canada's Health Products and Food Branch interprets and applies the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) for prescription products and those administered or obtained through a health professional. Please note that this includes prescription pharmaceutical drugs, biologic drugs (Schedule D), and radiopharmaceuticals (Schedule C).

Last Updated: Jul. 7, 2021
Date Published: May 14, 2020
Organization: Health Canada
Formats: HTML
Keywords:  questions and answers, plain language labelling regulations, prescription drugs, labelling, packaging and brand names of drugs, drugs for human use, prescription pharmaceutical drugs, biologic drugs, schedule-D
Federal

Food and Drug Regulations-Amendment (Schedule No.1024) Clinical Trial Framework

Last Updated: Jun. 7, 2022
Date Published: May 18, 2018
Organization: Health Canada
Formats: HTML
Keywords:  food-and-drug regulations, regulations-amendment, Schedule No.1024, 1024 clinical-trials, clinical-trial framework
Federal

This document provides information for industry on how Health Canada's Health Products and Food Branch interprets and applies the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) for non-prescription (Over-the-Counter, OTC) drug products. These amendments are commonly referred to as the Plain Language Labelling (PLL) Regulations.

Last Updated: Jul. 7, 2021
Date Published: Sep. 28, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, plain language labelling regulations, non-prescription drugs, 2014 Regulations Amending the Food and Drug Regulations, labelling, packaging and brand names, drugs for human use for non-prescription
Federal

(DIN) has been assigned for that drug and the assignment of the number has not been cancelled pursuant to section C.01.014.6. In the case of a new drug, a new drug submission filed pursuant to Division 8 of the Food and Drug Regulations is regarded as an application for a DIN. When a product is not subject to Division 8, the application is called a DIN submission.

Last Updated: Jul. 6, 2021
Date Published: Aug. 26, 2009
Organization: Health Canada
Formats: HTML
Keywords:  Guideline, drug identification number, DIN, preparation of DIN Submissions, ssection C.01.014, Food and Drug Regulations, section C.01.014.6., a new drug, a new drug submission
Federal

The purpose of this document is to provide guidance to sponsors to facilitate compliance with the labelling requirements pursuant to sections 3, 9, and 10 of the Food and Drugs Act as well as related provisions of the Food and Drug Regulations and the Controlled Drugs and Substances Act.

Last Updated: Jul. 7, 2021
Date Published: Sep. 15, 2015
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, labelling requirements, labelling of pharmaceutical drugs, drugs for human use, Food and Drugs Act
Federal

Health Canada and the U.S. Food and Drug Administration (FDA) are holding joint public consultation meetings on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines currently under development. The aim of this initiative is to hold public consultation meetings prior to each bi-annual ICH face-to-face meeting, in order to seek input on certain regulatory aspects that could be beneficial for the harmonisation of ICH guidelines.

Last Updated: Dec. 29, 2021
Date Published: Aug. 26, 2021
Organization: Health Canada
Formats: HTML
Keywords:  HC, USA Food and Drug Administration, Joint Public Consultation, International Council for Harmonisation, ICH, Technical Requirements, Pharmaceuticals for Human Use
Federal

This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in humans to understand and comply with Part C, Division 5 of the Food and Drug Regulations (the Regulations).

Last Updated: May 4, 2021
Date Published: Aug. 20, 2019
Organization: Health Canada
Formats: HTML
Keywords:  Guidance, Part C, Division 5, Food and Drug Regulations, Drugs for Clinical Trials, Clinical Trials Involving Human Subjects, GUI-0100
Date modified: