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An NOC/c is authorization to market a drug (i.e. a Notice of Compliance (NOC)), with the condition that the sponsor undertake additional studies to verify the clinical benefit. The NOC, qualifying under the NOC/c policy, is issued under section C.08.004 of the Food and Drug Regulations.
A Notice of Compliance (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.
The NOC lists are available in two formats, ASCII Text, and a "comma-delimited" database-text format (DBF) that can be imported into most database software packages. There are four types of NOCs: Biological, Prescription, Nonprescription and Veterinary. The NOCs are usually updated on Fridays.
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Frequently Asked Questions and Answers on Notice of compliance (NOC) database.
What is the Notice of Compliance (NOC) Data Extract?
The data extract is a series of compressed ASCII text files of the database. The uncompressed size of the files is approximately 28.5 MB. In order to utilize the data, the file must be loaded into an existing database or information system.
This guidance helps to classify safety and efficacy changes made to new drugs that have received a Notice of Compliance (NOC) pursuant to section C.08.004 of the Food and Drug Regulations (the Regulations).
This section highlights the range in categories of data and contextual information that may be relevant to the evaluation of a particular submission.
This section of the guidance provides criteria and examples to help you classify a safety or efficacy related change. Examples are not exhaustive and are meant to provide guidance on types of acceptable changes.