Notice of compliance (NOCC) database Frequently Asked Questions

1. What are the differences between the Drug Product Database (DPD) and the Notice of Compliance (NOC) Database?
2. Why is searching by "Medicinal/Active Ingredient" the best way to find similar products?
3. What happens when a company fulfills the conditions associated with a Notice of Compliance with conditions (NOC/c) and how will this be displayed on the NOC Database?
4. What does it mean when the notation N/A appears in the DIN field?
5. Why does the NOC Database contain records that only go back to 1994?
6. Are Summary Basis of Decision documents linked to NOC records?

1. What are the differences between the Drug Product Database (DPD) and the Notice of Compliance (NOC) Database?

• The DPD contains approximately 14,000 products that are available for sale in Canada and 25,000 that have been discontinued, but does not include radiopharmaceutical products.
• The NOC Database contains the Health Canada authorization dates for all drugs dating back to 1994 that have received an NOC.
• When Health Canada authorizes a product, it will appear in the DPD with the status “Approved”.

The need to use the two different databases occurs when seeking the current status of drugs.

For example:

• If "Drug X" has been removed from the market, the DPD would reflect this change. The drug status of "Drug X" will be changed from “Marketed” to “Cancelled (post-market)”. The NOC Database retains the historical records of all NOCs that have been issued for 'Drug X".

To determine the current status of a drug in Canada, search the Drug Product Database.

To determine the Canadian authorization date, search the NOC Database or the NOC Listings.

2. Why is searching by "Medicinal/Active Ingredient" the best way to find similar products?

Searching by Medicinal Ingredient will display all of the products that Health Canada has authorized since 1994 that contain a particular medicinal ingredient, either alone or in combination. Therefore, both "innovator" (name brand) and "generic" drugs with the same medicinal ingredient will be listed in the search results.

3. What happens when a company fulfills the conditions associated with a Notice of Compliance with conditions (NOC/c) and how will this be displayed on the NOC Database?

Once a sponsor provides Health Canada with satisfactory evidence of the drug's effectiveness, and Health Canada is satisfied that all the conditions agreed-upon at the outset have been met, the conditions associated with authorization will be removed in accordance with the NOC/c policy. A notation will be added to the original authorization in the NOC database reflecting the date that the conditions were met. The NOC/c will remain on the database for historical purposes but it will be clearly marked as having fulfilled all the conditions.

4. What does it mean when the notation N/A appears in the DIN field?

When "N/A" (Not Applicable) appears in the DIN field it means that for that particular NOC the DIN remained unchanged. A common example of this would be a new indication or a new dosage regimen.

5. Why does the NOC Database contain records that only go back to 1994?

The NOC Database only goes back to 1994 because over the years changes have been made to the regulatory review processes. These changes have made it difficult to keep a level of consistency and to merge data from years prior to 1994 with our present-day regulatory framework.

6. Are Summary Basis of Decision documents linked to NOC records?

Due to the migration of web content from the Health Canada site to Canada.ca, as of the date of this Notice, links to individual Summary Basis of Decision (SBD) documents for drug products will no longer be provided from the NOC database.

Some Final Notes

If you search by the Medicinal/Active Ingredient field, all the products with the same Medicinal/Active Ingredient will appear on the search results page.

Most generic drugs have a prefix, then a dash, followed by the recognized Medicinal/Active Ingredient name of the drug, for example, ABC-Medicinal Ingredient.

Generic Drugs authorized for sale prior to the Fall 1996 do not have a Canadian Reference Product listed since it was not a regulatory requirement.