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Notice of Compliance (NOC) Data Extract
Federal

What is the Notice of Compliance (NOC) Data Extract?
The data extract is a series of compressed ASCII text files …

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Notice-of-Compliance NOC NOC Data Extract
Post-Notice of Compliance changes: Guidance for safety and efficacy of veterinary drugs: …
Federal

This guidance helps to classify safety and efficacy changes made to new drugs that have received a Notice of Compliance …

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of compliance NOC post-NOC changes safety and efficacy veterinary drugs overview new drugs section C.08.004 Food-and-Drug Regulations
Post-Notice of Compliance changes: Guidance for safety and efficacy of veterinary drugs: …
Federal

This section highlights the range in categories of data and contextual information that may be relevant to the evaluation of …

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: post-notice of compliance-changes safety-and-efficacy veterinary drugs documentation data and contextual information
Post-Notice of Compliance changes: Guidance for safety and efficacy of veterinary drugs: …
Federal

This section of the guidance provides criteria and examples to help you classify a safety or efficacy related change. Examples …

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: post-notice of compliance-changes safety and efficacy veterinary drugs reporting categories
Rozlytrek - Notice of Compliance with Conditions - Qualifying Notice
Federal

Notice of Compliance with Conditions - Qualifying Notice.

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Rozlytrek notice of compliance NOC with Conditions qualifying notice
Summary: Guidance Document - Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, …
Federal

The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new …

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: summary guidance document post-notice-of-compliance-changes NOC framework document Pharmaceutical biologic radiopharmaceutical drugs for human-use-only framework Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs
Summary: Guidance Document- Post-Notice of Compliance (NOC) Changes: Safety and Efficacy
Federal

The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new …

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: summary guidance document post-notice of-compliance-changes safety-and-efficacy framework safety-and-efficacy quality guidance documents post-approval changes to-new-drugs
Vitrakvi - Notice of Compliance with Conditions - Qualifying Notice
Federal

Notice of Compliance with Conditions - Qualifying Notice.

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Vitrakvi notice of compliance NOC with Conditions qualifying notice
Arzerra - Notice of Compliance with Conditions - Qualifying Notice
Federal

Notice of Compliance with Conditions - Qualifying Notice.

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Arzerra notice of compliance NOC with Conditions qualifying notice
Balversa - Notice of Compliance with Conditions - Qualifying Notice
Federal

Notice of Compliance with Conditions - Qualifying Notice.

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Balversa notice of compliance NOC with Conditions qualifying notice