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Found 10 records similar to Updated: Notice - Notification of Safety Labelling Changes to the Product Monographs of Pharmaceutical Drug Products

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

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

A post-NOC change is any change that is made to a new drug that has received a NOC pursuant to section C.08.004 of the Food and Drug Regulations. Many of these changes may be made to improve the quality of the drug product or the efficiency of the manufacturing process, or they could be made for marketing considerations. Changes to the labelling of a drug product could include adding new indications, improving the management of risk for a product by adding warnings, limiting the target population or changing the dosage regime etc.

Last Updated: Jul. 7, 2021
Date Published: Apr. 1, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Post-Notice of Compliance, NOC Changes, framework document, pharmaceutical, biologic, radiopharmaceutical drugs, drugs for human use only
Federal

This guidance is intended to harmonize and to update the prescribing information for nonsteroidal anti-inflammatory drugs () indicated for controlling pain and inflammation associated with rheumatic diseases and other less severe conditions. Each Product Monograph is expected to contain objective, adequate and concise information on properties common to the active component and specific to the drug product. It should provide guidance on the safe and effective use of the drug, not only to the practitioner but also to the patient.

Last Updated: Jul. 7, 2021
Date Published: Aug. 7, 2009
Organization: Health Canada
Formats: HTML
Keywords:  Basic product mMonograph information, non-steroidal anti-inflammatory drugs, NSAIDs, controlling pain and inflammation, rheumatic diseases, product monograph contains objective, adequate and concise information on drug product, safe and effective use of the drug
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

This Notice serves to inform sponsors of drug submissions pursuant to Division C.08 of the Food and Drug Regulations (that is [i.e.], new drug and abbreviated new drug submissions) of changes in Health Canada's comparative bioavailability requirements for drug products which exhibit large pharmacokinetic within-subject variation in extent of absorption, as measured by area under the concentration versus time curve (AUC).

Last Updated: Jun. 1, 2021
Date Published: Apr. 18, 2016
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, drug submissions, new drug submissions, policy on bioequivalence standards, highly variable drug products, comparative bioavailability requirements, pharmacokinetic
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 and pharmaceutical and certain biotechnological products for veterinary 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: Aug. 12, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Post-notice of compliance, NOC changes, safety and efficacy document, changes to new drugs, section C.08.004 of the Food and Drug Regulations, pharmaceuticals, biologics, radiopharmaceuticals, human use
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

The Drug Product Database (DPD) system captures information on Canadian human, veterinary and disinfectant products approved for use by Health Canada. To facilitate the use of the drug product data, multiple Drug Product files are available. Users can access the complete data set through the “Drug Product” file. Subsets of the data can be accessed in the “Drug Product By …” files.

Last Updated: Feb. 9, 2022
Date Published: Dec. 9, 2002
Organization: Health Canada
Formats: XML JSON CSV HTML
Keywords:  dpd, drug product, pharmaceutical drugs, biological drugs, brand name, drug identification number, din, company, active ingredient
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
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