Service Standard for the Right to Sell Drugs under the Food and Drug Regulations – Health Canada

Service Description:

Health Canada posts service standards and performance information for services with over 100 regulatory authorizations, such as permits or licences, issued each year (high-volume regulatory transactions).

Before a drug is authorized for sale in Canada, it must be issued a Drug Identification Number (DIN) in accordance with section C.01.014.2 or C.08.002 of the Food and Drug Regulations. Also in accordance with section C.01.014.5 of the Food and Drug Regulations, a manufacturer of a drug must annually, before October 1, notify Health Canada that the drug is still on the market and that all the information previously provided pertaining to the drug is correct.

The Fees for the Right to Sell Drugs guidance document provides manufacturers and regulatory correspondents guidance on the step by step process for annual notification in accordance with section C.01.014.5 of the Food and Drug Regulations.

Service Standard:

The Health Products and Food Branch (HPFB) commits to service delivery standard of 120 calendar days, from the receipt of annual notification, to update the Drug Product Database.

Performance Target:

The target for achieving this standard is set at 100% of updates made within the applicable review timelines.

Performance result for fiscal year 2020 to 2021:

Annual service performance is measured over the course of the fiscal year (April 1 - March 31). Performance results for a given fiscal year are published in the Report on Fees, which is normally tabled in Parliament and published in the third quarter (October-December) of the following fiscal year.

In 2020-2021, HPFB's actual result for these updates was 100% made within 120 calendar days.

Departmental Contacts:

To make any general inquiries or comments, please contact:

Office of Submissions and Intellectual Property
Resource Management and Operations Directorate
Health Canada
E-mail: annual-annuelle@hc-sc.gc.ca  
Telephone: 613-946-1151
Fax: 613-954-3067

On Cost Recovery:
E-mail:  cro-brc@hc-sc.gc.ca
Telephone: 613-617-7323
Fax: 613-954-9981