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Found 10 records similar to Post-Notice of Compliance (NOC) Changes: Framework Document

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. 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

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. 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

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

The publication of the National Occupational Classification (NOC) 2021 is the thirtieth anniversary of the standard occupational classification system and it introduces a major structural change. The NOC 2021 Version 1.0 overhauls the "Skill Level" structure by introducing a new categorization representing the degree of Training, Education, Experience and Responsibilities (TEER) required for an occupation. The NOC 2021 Version 1.0 also introduces a new 5-digit hierarchical structure, compared to a 4-digit hierarchical structure in the previous versions of the classification. The NOC has been developed and maintained as part of a collaborative partnership between Employment and Social Development Canada and Statistics Canada.

Last Updated: Nov. 14, 2022
Date Published: Sep. 21, 2021
Organization: Statistics Canada
Formats: PDF HTML CSV
Keywords:  Classification, Classification codes, Classification systems, Industrial classification, Business statistics, Industry - Standard classifications
Federal

The National Occupational Classification (NOC) 2016 Version 1.2 updates the National Occupational Classification 2016 Version 1.1. The NOC has been developed and maintained as part of a collaborative partnership between Employment and Social Development Canada and Statistics Canada. This update of the classification was completed in response to the legalization of cannabis for non-medical use. This has resulted in twenty five new job titles being created in NOC 2016 V1.2 to reflect new occupations in the cannabis industries.

Last Updated: Apr. 5, 2019
Date Published: Dec. 19, 2018
Organization: Statistics Canada
Formats: HTML CSV
Keywords:  Classification, Classification codes, Classification systems, Industrial classification, Business statistics, Industry - Standard classifications
Federal

The National Occupational Classification (NOC) 2016 updates the National Occupational Classification 2011. The NOC has been developed and maintained as part of a collaborative partnership between Employment and Social Development Canada and Statistics Canada. This update of the classification reflects ongoing occupational research and consultation to incorporate information on new occupations.

Last Updated: Feb. 21, 2022
Date Published: May 16, 2016
Organization: Statistics Canada
Formats: HTML CSV
Keywords:  Classification, Classification codes, Classification systems, Industrial classification, Business statistics, Industry - Standard classifications
Federal

The NOC is the product of a partnership between Statistics Canada and Employment and Social Development Canada. The National Occupational Classification (NOC) is the nationally accepted taxonomy and organizational framework of occupations in the Canadian labour market. The basic principle of classification of the NOC is that of kind of work performed. The NOC 2011 updates both the National Occupational Classification 2006 of Employment and Social Development Canada and Statistics Canada's National Occupational Classification for Statistics (NOC-S) 2006.

Last Updated: Feb. 21, 2022
Date Published: Nov. 21, 2011
Organization: Statistics Canada
Formats: PDF CSV HTML
Keywords:  Classification, Classification systems, Occupational classification, Occupations, NOC, NOC-S, SOC
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