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Found 10 records similar to Drug Product Database - All Files

Federal

The NOC is issued to a manufacturer following the satisfactory review of a submission for a new drug, and signifies compliance with the Food and Drug Regulations. The database is updated nightly and contains NOC information on human drugs from January 1, 1994 to date. It also contains NOC information on Veterinary drugs from September 19, 2000 to date.

Last Updated: Feb. 24, 2022
Date Published: Dec. 18, 2017
Organization: Health Canada
Formats: XML JSON HTML
Keywords:  NOC, veterinary drugs, DIN
Federal

Health Canada's Clinical Trials Database is a listing of information about phase I, II and III clinical trials in patients. The database is managed by Health Canada and provides a source of information about Canadian clinical trials involving human pharmaceutical and biological drugs.

Additional information on Health Canada’s CTD is available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/health-canada-clinical-trials-database/frequently-asked-questions.html

Last Updated: Feb. 2, 2022
Date Published: Dec. 18, 2017
Organization: Health Canada
Formats: XML JSON HTML
Keywords:  CTAs, CTD, Phase I, II, and III, clinical trials, database, manufacturer, medical condition
Federal

Health Canada will continue to post a monthly table on the Department website which reflects updated and/or new safety information in PMs of brand name pharmaceutical drug products (those regulated under Division 8 of the Food and Drug Regulations only). This table will identify the section of the PM that was updated pursuant to a Supplement to an (Abbreviated) New Drug Submission (S(A)NDS).

Last Updated: Dec. 29, 2021
Date Published: Mar. 23, 2020
Organization: Health Canada
Formats: HTML
Keywords:  safety labelling changes, product monographs, PMs, pharmaceutical drug products, a monthly table, safety information
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

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 guide is for anyone working with drugs or natural health products. It will help facilitate understanding and compliance with sections of the Food and Drugs Act (the Act), the Food and Drug Regulations (FDR) and Natural Health Products Regulations (NHPR) that relate to recalls.

Last Updated: Sep. 9, 2021
Date Published: Feb. 27, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, NHPs, recalls
Federal

This guide is for anyone working with drugs or natural health products. It will help facilitate understanding and compliance with sections of the Food and Drugs Act (the Act), the Food and Drug Regulations (FDR) and Natural Health Products Regulations (NHPR) that relate to recalls.

Last Updated: Apr. 27, 2021
Date Published: Jul. 23, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Guide, drug recall, natural health products recall, recalls
Federal

Drug and medical device manufacturers submit clinical information to Health Canada for the approval of new products. Health Canada assesses this clinical information to reach a decision on whether or not to approve a drug or medical device.

Last Updated: Sep. 17, 2020
Date Published: Feb. 28, 2019
Organization: Health Canada
Formats: HTML
Keywords:  Clinical information, approval of new drug and health products.
Federal

The Special Access Programme (SAP) provides access to nonmarketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP authorizes a manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada.

Last Updated: May 5, 2020
Date Published: Jul. 5, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Special Access Program, Non-marketed drugs.
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
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