We report in the Regulatory Essentials, details of HPCD-SHIELD’s performance standards on Site Licensing. We have received clarification on what the term “Site Clock Day” represents as there has been some confusion around this term.
As it relates to service standards, the term “Site Clock Day” is a count of how far along a submission is in its review timeline.
The review timeline:
Begins at Day 1 once the submission is received by HPCD (i.e. the submission is at Site Clock Day 1). When a site license submission is administratively complete, Health Canada issues an acknowledgment of receipt notice, starting the review timeline. The submission then moves through a screening process by which the review timeline in “Site Clock Days” continues to count towards the service standard unless additional information is required, in this case the review timeline will pause and remain at a certain “Site Clock Day” until a response is received.
Thus, if additional information is required (e.g., via clarimail or information request notices), the review timeline will pause and this will be communicated in the clarimail or information request notice. The timeline resumes when the requested information is received and the “Site Clock Day” continues to count towards the submission’s service standard.
As a reminder, the service standard for the management of all types of site licence applications (new applications, renewals, or amendments) depends on the type of Good Manufacturing Practices (GMP) evidence provided and the number of sites listed on the application:
- Stream 1 (Unlimited site number and includes pre-cleared evidence for every site):
35 business days
- Stream 2 (1-9 sites and includes non pre-cleared evidence for one or more sites):
65 business days
- Stream 3 (10+ sites and includes non pre-cleared evidence for one or more sites):
95 business days
