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Found 10 records similar to Non-prescription Drugs: Category IV Monographs

Federal

A non-prescription drug Category IV Monograph outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions for use, warnings, active ingredients and combinations thereof.

Last Updated: Sep. 9, 2021
Date Published: Aug. 30, 2019
Organization: Health Canada
Formats: HTML
Keywords:  Non-prescription drugs, category IV monographs, use and labelling requirements, dose, intended use, directions for use, warnings, active ingredients
Federal

A nonprescription drug labelling standard outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions for use, warnings, active ingredients and combinations thereof. Labelling standards are developed for drugs that have a well characterized safety and efficacy profile under specific conditions of use.

Last Updated: Jul. 7, 2021
Date Published: Sep. 15, 2016
Organization: Health Canada
Formats: HTML
Keywords:  Non-prescription Drugs, labelling standards, drug product, permissible conditions of use, labelling requirements, dose, intended use, directions for use, warnings
Federal

Labelling standards are developed for drugs that have a well characterized safety and efficacy profile under specific conditions of use. A manufacturer may reference a labelling standard in a drug submission when the product and its labelling are consistent with the information set out in the document.

Last Updated: Sep. 9, 2021
Date Published: Nov. 17, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Non-prescription drugs, labelling standards, drug product, safety and efficacy profile, specific conditions of 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 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

The safe use of non-prescription drugs depends on consumers being able to identify the desired product and also being able to understand and act upon the information presented. The label and package are the first points of interaction between a health product and a consumer or healthcare professional. Prior to the implementation of the Plain Language Labelling (PLL) initiative, the general practice in Canada was to present key information within blocks of text on the product label. This guidance document provides prescriptive information on the design specifications, required sections of the CDFT, and labelling content.

Last Updated: Jul. 7, 2021
Date Published: Feb. 16, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Labelling requirements, non-prescription drugs, safe use of non-prescription drugs, guidance document, label and package, a health product and a consumer, a health product and healthcare professional, plain language labelling
Federal

A product monograph is a factual, scientific document on a drug product. It does not contain promotional material. The monograph describes the properties, claims, indications and conditions of use for the drug. It also contains any other information that may be required for optimal, safe and effective use of the drug.

Last Updated: Jul. 28, 2022
Date Published: Oct. 29, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, COVID-19 drugs, market authorization requirements, drug manufactured, sold, regulatory process, labelling requirements, post-market requirements
Federal

The Drug Facts Table provides a standardized format and location (on the label) for important product information. This helps consumers find and compare information quickly and easily.

Last Updated: Sep. 13, 2021
Date Published: Aug. 23, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, NHPs, non-prescription drugs, drug facts table, Non-prescription drugs, product information, standardized format, location, product information
Federal

The purpose of this guidance document is to assist sponsors in developing product monographs with acceptable format and content. Health Canada reviews the product monograph as part of the drug review process, as it forms an integral part of a new drug submission. A product monograph is intended to provide the necessary information for the safe and effective use of a new drug and also to serve as a standard against which all promotion and advertising of the drug can be compared.

Last Updated: Jul. 7, 2021
Date Published: Nov. 1, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, product monograph, product monograph 2020, an integral part of a new drug submission, necessary information for the safe and effective use of a new drug
Federal

This proposed guidance will assist manufacturers, packagers, and distributors of non-prescription drugs in developing plain language labelling content for a Facts Table in a standardized format so that consumers can find important product information quickly and easily.

Last Updated: Jul. 7, 2021
Date Published: Sep. 28, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, drug facts table, non-prescription drugs, plain language labelling, important product information
Federal

The Drug Facts Table for Non-prescription Drugs Guidance Document gives direction for designing safe and clear labels and packages.

Last Updated: Sep. 9, 2021
Date Published: Aug. 21, 2019
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, NHPs, Non-prescription drugs, a new Drug Facts Table, supporting improved labelling
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