Health Canada announces the upcoming launch of the updated version of the Notice of Compliance (NOC) Online Database and the addition of Weekly Data Extracts which will replace the current NOC listings

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July 16, 2010

Notice

Our file number: 10-115915-196

Re: Health Canada announces the up-coming launch of the updated version of the Notice of Compliance (NOC) Online Database and the addition of Weekly Data Extracts which will replace the current NOC Listings.

The NOC Database contains specific drug product information on drugs authorized for sale in Canada. An 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 and Veterinary drugs from January 1, 1994 to date. The NOC reflects the information available to Health Canada at the time of issuance.

Information available in the database includes, but is not limited to, the following parameters: Brand/Product Name, Drug Identification Number (DIN), manufacturer, dosage form, routes of administration, active/medicinal ingredient(s), strength of the active/medicinal ingredient, submission type and class, Canadian authorization date, and therapeutic class.

The updated version soon to be launched contains the same information as the current NOC Online Database with formatting changes to meet Common Look and Feel 2.0 requirements. The major difference will be the introduction of a weekly extract which will replace the current NOC listings.

NOC Online Database Weekly Data Extract

Similar to the Drug Product Database (DPD) data extract; Health Canada will be releasing a weekly set of data extracts for the NOC Online Database. This data extract will be a series of compressed ASCII text files of the database. These extracts will contain most of the information currently provided in the NOC listings but formatted differently. The uncompressed size of the files is approximately 2.5 MB. In order to utilize the data, the file must be loaded into an existing database or information system. The typical user is most likely a third-party claims adjudicator, provincial formulary, insurance company, etc. A casual user of this file must be familiar with database structure and capable of setting up queries. A "Read me" file will be created that contains the data structure required to download the zipped files.

Please note any Portable Document Format (PDF) files visible on the NOC Online Database will not be part of the data extracts created weekly.

The expected launch date of the revised database is mid August and the NOC Listing will be discontinued in mid September. Once the revised database is launched, there will be a period of one month for transition to the use of these extracts. The NOC Online data extract will be updated weekly on every Friday.

Should you have any questions or comments regarding the content of the notice, please contact:

Submission and Information Policy Division
Therapeutic Products Directorate
Health Canada
101 Tunney's Pasture Driveway
Address Locator 0201A1
Ottawa, Ontario
K1A 0K9

Phone: 613-957-3123
Fax: 613-941-0825
E-Mail: SIPDMAIL@hc-sc.gc.ca