Forms and templates on applications and submissions for biologic and radiopharmaceutical drugs
To help expedite the review process, manufacturers or sponsors are expected to use the appropriate forms or templates when filing submissions with the Biologic and Radiopharmaceutical Drugs Directorate. These forms summarize drug submission data related to quality, safety or efficacy.
Some documents are only available by request and are labeled as "available upon request". When you select one of those links, an email message will open with the required information already filled in. Simply 'Send' the message. Alternatively, you can create an email to no.reply.BRDD.Publications-DMBR.non.reponse@hc-sc.gc.ca, and use the requested subject line as specified for each document below.
Submission quality templates
- Certified product information document-biologics (CPID-B) (available upon request at no.reply.BRDD.Publications-DMBR.non.reponse@hc-sc.gc.ca). The email subject line must read 'Request for CPID-B'.
- Quality overall summary-biologics (QOS-B) (available upon request at no.reply.BRDD.Publications-DMBR.non.reponse@hc-sc.gc.ca). The email subject line must read 'Request for QOS-B'.
Lot Release Program forms and templates for Schedule D (biologic) drugs
- Group 1A lot notification form (available upon request at no.reply.BRDD.Publications-DMBR.non.reponse@hc-sc.gc.ca). The email subject line must read 'Request for Group 1A Notification Form'.
- Group 4 lot notification form (available upon request no.reply.BRDD.Publications-DMBR.non.reponse@hc-sc.gc.ca). The email subject line must read 'Request for Group 4 Notification Form'.
- Periodic quality report template (PQR) (available upon request at no.reply.BRDD.Publications-DMBR.non.reponse@hc-sc.gc.ca). The email subject line must read 'Request for PQR Template'.
- Periodic quality report template – Annotated version (available upon request at no.reply.BRDD.Publications-DMBR.non.reponse@hc-sc.gc.ca). The email subject line must read 'Request for PQR Template'.
Guidance on the Lot Release Program for Schedule D (biologic) drugs
Human drugs reconsideration template
Supplement to a new drug submission (SNDS) for biosimilar products – Addition of an indication
- Sponsor attestation: SNDS for biosimilar products – Addition of indication to product monograph to be in line with the Canadian reference biologic drug (available upon request at no.reply.BRDD.Publications-DMBR.non.reponse@hc-sc.gc.ca). The email subject line must read ‘Request for Sponsor Attestation’.
Guidance on information and submission requirements for biosimilar biologic drugs