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Found 10 records similar to Notice of Compliance Brand

Federal

A Notice of Compliance is a notification, issued pursuant to paragraph C.08.004(1)(a), indicating that a manufacturer has complied with sections C.08.002 or C.08.003 and C.08.005.1 of the Food and Drug Regulations. Notices of Compliance are issued to a manufacturer following the satisfactory review of a submission. The NOC extract files contain Health Canada authorization dates for all drugs dating back to 1994 that have received an NOC. There are four types of NOCs: Biological, Prescription, Nonprescription and Veterinary.

Last Updated: Feb. 22, 2022
Date Published: Aug. 19, 2010
Organization: Health Canada
Formats: TXT
Keywords:  notice of compliance listings, notices of compliance with conditions
Federal

A Notice of Compliance is a notification, issued pursuant to paragraph C.08.004(1)(a), indicating that a manufacturer has complied with sections C.08.002 or C.08.003 and C.08.005.1 of the Food and Drug Regulations. Notices of Compliance are issued to a manufacturer following the satisfactory review of a submission. The NOC extract files contain Health Canada authorization dates for all drugs dating back to 1994 that have received an NOC. There are four types of NOCs: Biological, Prescription, Nonprescription and Veterinary.

Last Updated: Feb. 22, 2022
Date Published: Aug. 19, 2010
Organization: Health Canada
Formats: TXT
Keywords:  notice of compliance listings, notices of compliance with conditions
Federal

A Notice of Compliance is a notification, issued pursuant to paragraph C.08.004(1)(a), indicating that a manufacturer has complied with sections C.08.002 or C.08.003 and C.08.005.1 of the Food and Drug Regulations. Notices of Compliance are issued to a manufacturer following the satisfactory review of a submission. The NOC extract files contain Health Canada authorization dates for all drugs dating back to 1994 that have received an NOC. There are four types of NOCs: Biological, Prescription, Nonprescription and Veterinary.

Last Updated: Feb. 22, 2022
Date Published: Aug. 19, 2010
Organization: Health Canada
Formats: TXT
Keywords:  notice of compliance listings, notices of compliance with conditions
Federal

A Notice of Compliance is a notification, issued pursuant to paragraph C.08.004(1)(a), indicating that a manufacturer has complied with sections C.08.002 or C.08.003 and C.08.005.1 of the Food and Drug Regulations. Notices of Compliance are issued to a manufacturer following the satisfactory review of a submission. The NOC extract files contain Health Canada authorization dates for all drugs dating back to 1994 that have received an NOC. There are four types of NOCs: Biological, Prescription, Nonprescription and Veterinary.

Last Updated: Feb. 22, 2022
Date Published: Aug. 19, 2010
Organization: Health Canada
Formats: TXT
Keywords:  notice of compliance listings, notices of compliance with conditions
Federal

A Notice of Compliance is a notification, issued pursuant to paragraph C.08.004(1)(a), indicating that a manufacturer has complied with sections C.08.002 or C.08.003 and C.08.005.1 of the Food and Drug Regulations. Notices of Compliance are issued to a manufacturer following the satisfactory review of a submission. The NOC extract files contain Health Canada authorization dates for all drugs dating back to 1994 that have received an NOC. There are four types of NOCs: Biological, Prescription, Nonprescription and Veterinary.

Last Updated: Feb. 22, 2022
Date Published: Aug. 19, 2010
Organization: Health Canada
Formats: TXT
Keywords:  notice of compliance listings, notices of compliance with conditions
Federal

A Notice of Compliance is a notification, issued pursuant to paragraph C.08.004(1)(a), indicating that a manufacturer has complied with sections C.08.002 or C.08.003 and C.08.005.1 of the Food and Drug Regulations. Notices of Compliance are issued to a manufacturer following the satisfactory review of a submission. The NOC extract files contain Health Canada authorization dates for all drugs dating back to 1994 that have received an NOC. There are four types of NOCs: Biological, Prescription, Nonprescription and Veterinary.

Last Updated: Feb. 22, 2022
Date Published: Aug. 19, 2010
Organization: Health Canada
Formats: TXT
Keywords:  notice of compliance listings, notices of compliance with conditions
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. 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 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
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