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. What is a Summary Basis of Decision?
7. What is a Notice of Decision?
8. Why aren't all NOCs accompanied by a Notice of Decision/Summary Basis of Decision?
9. What is the Product Monograph Part III: Consumer Information?

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 a sponsor notifies Health Canada that an authorized product is being marketed, it will appear in the DPD.

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 DPD would remove "Drug X" from the active list and move it to the discontinued list. The NOC Database retains the historical records of all NOCs that have been issued for 'Drug X".
• If "Drug Y" is found in the NOC Database but is not listed in the DPD, this means that the product has not been marketed in Canada.

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. What is a Summary Basis of Decision?

A summary Basis of Decision (SBD) is a document that outlines the scientific and benefit/risk based considerations that factor into Health Canada's decision to grant market authorization for a drug or medical device. The document includes regulatory, safety, efficacy and quality (chemistry and manufacturing) considerations.

7. What is a Notice of Decision?

A Notice of Decision (ND) is a one-page summary outlining the authorization received and general information related to the drug or medical device. NDs will be published independently within approximately two weeks of product authorization. When the SBD is published, the ND will be incorporated into the SBD as Section 2.

8. Why aren't all NOCs accompanied by a Notice of Decision/Summary Basis of Decision?

Summary Basis of Decisions will be implemented in a phased approach beginning with New Drug Submissions for New Active Substances authorized after January 1, 2005.

9. What is the Product Monograph Part III: Consumer Information?

The Product Monograph Part III: Consumer Information is a lay-language translation of information contained in Parts I (Health Professional Information) and II (Scientific Information) of the product monograph. For more information, refer to the Health Canada guidance document Product Monographs.

For the purposes of the product monograph, "consumer" is defined as the general public. It may include an individual using the drug, a caregiver or someone who is simply interested in obtaining information about a drug.

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.