Request from Health Canada
Health Canada can request for update notices or clarification during screening or review of the submission.
There are no restrictions on the information that may be added to or removed from the original NDS, SNDS, ANDS, or SANDS in the updated submission. Update Notice will be issued by the Director of the reviewing Bureau/Centre.
During the screening or review of the submission, including the label review, a Bureau/Centre may seek clarification of specific information in the submission. Requests will be solicited by facsimile and must be responded to in writing, directly to the requester. Responses up to 15 pages that do not contain data in tabular format should be faxed directly to the requester with no hard copy. If the response exceeds 15 pages or includes data in tabular format, hard copy only should be sent by courier directly to the requester.
Atinza will assist clients to response to these Notices of Health Canada promptly to expedite evaluation process and speed up the time to market of your products.
Notices of Deficiency (NOD)
Only one NOD per submission will be issued. Review of the submission will stop on the date of the NOD. The review of the submission in the other review streams may or may not be complete at the time of the issuance of a NOD.
Atinza will support clients to response to NOD in due time (90 days for NDSs, SNDSs, SNDS-Cs, ANDSs and SANDSs) and 45 days for DINAs (Drug Identification Number Application).
Notices of Noncompliance (NON)
After the comprehensive review of a submission is complete, a NON will be issued if the submission is deficient or incomplete in complying with the requirements outlined in the Food and Drugs Act and Regulations. For submissions under the jurisdiction of TPD, the NON will be issued by the unit manager in the appropriate review Bureau for DINAs and by the Director General for all other submission types. For Biologics and Genetic Therapies Directorate (BGTD) submissions, the NON will be issued by the Director General for all submission types.
- Health Canada will consider a sponsor’s failure to submit the solicited information within the assigned time frame, as a request to withdraw the submission.
- Atinze will ensure timely response to inquiries of Health Canada on behalf of the clients
Notice of Compliance (NOC)
A NOC/c-QN will be issued by the Director of the responsible reviewing Bureau/Centre upon completion of a review, should a submission be determined to qualify for further consideration under the NOC/c policy. The NOC/c – QN will indicate that the submission qualifies for a NOC, under the NOC/c policy, as well as outline the additional clinical evidence to be provided in confirmatory studies, post-market surveillance responsibilities and any requirements related to advertising, labeling, or distribution. Submission review will cease upon issuance of the Qualifying Notice.
- Health Canada will consider a sponsor’s failure to submit the solicited information within the assigned time frame, as a request to withdraw the submission.
- Atinza will support clients to submit the appropriate information and material within the required 30 days of receipt of the NOC/c-QN to Submission and Information Policy Division.