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Found 10 records similar to Notice of Compliance Database (NOC) API

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

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 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

After a new drug as defined in section C.08.001 of the Food and Drug Regulations has been granted a Notice of Compliance (NOC), it is not uncommon for sponsors to make changes to the drug. 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: Aug. 27, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Post-Notice of Compliance, NOC Changes, framework document, changes to the drug, section C.08.004 of the Food and Drug Regulations
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 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. This may include pharmaceuticals, biologics and radiopharmaceuticals for human use and pharmaceutical, radiopharmaceutical and certain biotechnological products for veterinary use.

Last Updated: Jul. 7, 2021
Date Published: Aug. 26, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Post-Notice of Compliance, NOC Changes, quality guidance, changes to new drugs, section C.08.004 of the Food and Drug Regulations, pharmaceuticals, biologics, radiopharmaceuticals, drugs for human use
Federal

Health Canada is pleased to announce the release of five associated revised draft guidance documents on Post-Notice of Compliance (NOC) Quality Changes for pharmaceutical, biologic and radiopharmaceutical drugs for human use, for stakeholder consultation.

Last Updated: Dec. 29, 2021
Date Published: Jul. 30, 2021
Organization: Health Canada
Formats: HTML
Keywords:  draft revised guidance, post-notice of compliance, changes for pharmaceutical, changes for biologic, changes for radiopharmaceutical, drugs for human-use, for stakeholder consultation
Federal

Unfortunately, the text-based data extract is no longer accessible through the Natural and Non-prescription Health Products (NNHPD) website. We want to underline that the support for the CSV (text) extract formats has been dropped by our program area and the links to CSV files on the page will be deleted soon. However, the alternative formats XML and JSON are both available and are updated daily and will continue to be moving forward. .For the most recent LNHPD extract you can retrieve either XML or JSON extracts from our API.

Last Updated: Feb. 22, 2022
Date Published: Dec. 18, 2009
Organization: Health Canada
Formats: XML JSON CSV HTML
Keywords:  medicinal ingredients, product specific information, natural health products, product licence, natural product number, npn, homeopathic medicine number, din-hm, vitamin
Federal

Health Canada’s Veterinary Drugs Directorate (VDD) is clarifying the expectations for the information about Good Manufacturing Practices (GMP) status that should accompany veterinary drug submissions.

Last Updated: Jul. 8, 2021
Date Published: Feb. 16, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Notice, submission filing recommendations, veterinary drugs, good manufacturing practices, drug establishment licences
Federal

Importing and exporting health products is regulated under the Food and Drugs Act and its associated Regulations. Some health products may also have additional restrictions placed on them by other Acts and Regulations.

Last Updated: Apr. 26, 2021
Date Published: Feb. 15, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Compliance and enforcement, Import and export of drugs, Import and export of health products
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