Service Standard for Drug Establishment Licences under the Food and Drug Regulations
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).
A Drug Establishment Licence (DEL) is required for any person in Canada engaged in any of the six licensable activities with respect to drugs under the Food and Drug Regulations of the Food and Drugs Act. The six licensable activities are: fabricate, package/label, test, import, distribute and wholesale.
The Guidance on Drug Establishment Licensing and Drug Establishment Licence Fee (GUI-0002) is intended to explain sections C.01A.001 to C.01A.019 of the Food and Drug Regulations. The Regulations outline the responsibilities of persons who conduct licensable activities in Canada, as well as Health Canada's responsibilities. The guide describes what a DEL is and when it is required, who is required to hold a DEL, and the activities requiring a DEL. The application requirements are described, including how to obtain a new DEL, how and when to amend an existing EL and the annual review of DELs.
The Regulatory Operations and Enforcement Branch (ROEB) of Health Canada commits to a service delivery standard of 250 calendar days of Health Canada review time, from the receipt of a complete application, to the issuance of a decision. The service standard applies to DEL applications that are subject to fees, including annual license review applications, applications for a new DEL and applications to amend a DEL.
The target for achieving the standard is set at an annual average time to complete DEL applications being no greater than 250 days.
Performance result in fiscal year 2018 to 2019:
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 Departmental Results Report, which is normally tabled in Parliament and published in the third quarter (October-December) of the following fiscal year.
In 2018-2019, ROEB's actual performance was 100% as it took 75 days on average to issue decisions on DEL applications that were subject to fees. Of those applications subject to fees, 96% had a decision issued within the 250-day service standard. Incomplete applications can lead to the process taking longer than 250 days to issue a decision.
Please contact the Drug Establishment Licensing Unit to make any general inquiries or comments:
Drug Establishment Licensing Unit (DELU):
200 Eglantine Driveway
13th Floor, Jeanne Mance Building
Address Locator: 1913B
Ottawa, Ontario K1Y 1G9
Teletypewriter: 1-800-267-1245 (Health Canada)
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