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Found 10 records similar to Guidance Document on the Distribution of Drugs as Samples - Summary

Federal

The purpose of this document is to assist stakeholders with the interpretation of legislation and regulatory requirements about distributing samples of prescription drugs, non-prescription drugs and natural health products.

Last Updated: Jul. 6, 2021
Date Published:
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, distributing samples, distribution of drugs as samples, legislation and regulatory requirements, prescription drugs, non-prescription drugs, natural health products
Federal

When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the manufacturer and printed on the package labels. A DIN indicates that the evaluation of the drug determined that it met the relevant requirements of the Food and Drugs Act and its regulations and the drug has a favourable risk/benefit profile. Manufacturers of prescription and non-prescription drugs must obtain a DIN before they are marketed in Canada

Last Updated: Jul. 6, 2021
Date Published:
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, regulatory requirements, DIN, drug identification numbers, summary, a drug to be marketed in Canada, DIN printed on the package labels, prescription and non-prescription drugs, obtain a DIN
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
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

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

Health Canada is publishing this document to be transparent about the principles and factors that it considers when deciding whether a drug would be best sold as a prescription or nonprescription product. This document is also designed to help the public, industry and healthcare professionals, including veterinarians, as well as other stakeholders, better understand and predict when a drug will be authorized as a prescription or nonprescription product.

Last Updated: Jul. 7, 2021
Date Published: Jun. 21, 2013
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, determining prescription status for human drugs, determining prescription status for veterinary drugs, authorized as a prescription or nonprescription product
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

Under this Framework, Health Canada will advance a new approach to the regulation of consumer health products. The key enabler of the approach is the proposal to create new regulations for non-prescription drugs, supported by ongoing operational improvements.

Last Updated: Sep. 9, 2021
Date Published: Mar. 16, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Consumer health products, framework, regulation of consumer health products, regulations for non-prescription drugs
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

This document describes how Health Canada's Health Products and Food Branch (HPFB) interprets the flexibility allowing for the use of a URL on Category IV products, mouthwash and toothpaste as described in the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products (GLPPG).

Last Updated: Sep. 10, 2021
Date Published: Oct. 12, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Non-prescription drugs, natural health products, drug facts table, eCDFT, technical Standards, Category IV products, mouthwash, toothpaste, good label and package practices guide
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