Ontario Public Drug Programs

SUBMISSION SUMMARY

For Submissions under DIDFA, Regulation 935, Section 6

Drug Product (Brand name/generic name/strengths):

Original Drug Product (to which interchangeability designation is sought):

Submitting Manufacturer:

Please complete all items

Submission Type (select one): ☐First Review ☐Second Review: Master File #: ☐Reconsideration: Master File #: ☐Meeting Request: Master File #:

Category/Designation a. Submission Category (select one): ☐New Product ☐New Strength ☐New Indication ☐New Dosage ☐New Format ☐Notice of Change

b. If applicable, list Formulary designation sought (select one): ☐Interchangeable ☐Facilitated Access ☐EAP Rapid Review Request: Request for a “rapid review” for this submission: ☐Yes ☐No Page Ref.:

Justification provided for “rapid review” request: 1 ☐Yes ☐No Page Ref.:

2 SUBMISSION SUMMARY – Page 2

Source and Authorization for Submission: a. Submitting manufacturer of the submission indicated: b. Is the submitting manufacturer the holder of the NOC? ☐Yes ☐No

If not, provide information for (c) and (d) c. Letter from NOC holder authorizing submitting manufacturer to submit on NOC holder’s behalf: ☐Yes ☐No Page Ref.: d. Relationship between each party detailed: ☐Yes ☐No Page Ref.: Administrative Issues a. Two complete sets of the submission provided: ☐Yes ☐No b. Number of binders that make up each set of a submission: c. Submission is well organized, tabbed and indexed according to the relevant

section of the requirements:☐Yes ☐No

d. A table of contents is included in the submission: ☐Yes ☐No

Submission Data: a. Schedule of drug Classification: ☐Guideline A ☐Guideline B ☐Report C

b. Drug Status: ☐New Drug ☐Old Drug

If applicable, specify which exemptive regulations were applied for: ☐6.(2) ☐6.(3) ☐6.(4) ☐6.(5) ☐6.(6) ☐6.(7)

3 SUBMISSION SUMMARY – Page 3

Interchangeability Information

a. Bioequivalence declared to the Canadian Reference Product on the NOC: ☐Yes ☐No Page Ref.: b. Reference product is the same as the Ministry’s original product: ☐Yes ☐No Page Ref.: c. Reference product is currently listed in the Formulary/CDI: ☐Yes ☐No d. If reference product is not currently listed in the Formulary/CDI, specify the edition, supplement, and page number indicating when the original product was first listed: Edition: Supplement: Page Ref.:

Bioavailability Data

a. Bioavailability study report provided: ☐Yes ☐No Page Ref.:

If not, please provide justification/exemption: b. Bioavailability test lots have the same formulation as the submitted lot: ☐Yes ☐No Page Ref.: c. Clarification/evidence provided of linkage if product names different in (b): ☐Yes ☐No Page Ref.: