"Sponsor Attestation S(A)nds for Generic Drugs - Product Monograph Updates to Be Line With the Crp" - Canada

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Sponsor Attestation
S(A)NDS for Generic Drugs - Product Monograph Updates to be in
line with the CRP
Brand (Proprietary) Name of Drug Product
Drug Substance / Medicinal Ingredient
Manufacturer / Sponsor
Dosage Form(s) and Strength(s)
ab
Canadian Reference Product (CRP)
Reason for Submission
Product Monograph (PM) update based on CRP’s PM;
control number:
Product Monograph update based on another labelling reference’s PM;
control number
Please specify the product used as a reference:
Please specify the reason the CRP’s PM was not used:
Was this filed in response to
Yes - Response to Advisement letter dated:
(YYYY/MM/DD)
an advisement letter
as per CRP PM update; control number
No
Confirm that the following
The Labels and Packages Certification Form
required documents are
Annotated PM against the most recent CRP PM dated:
provided:
(YYYY/MM/DD)
- Note: Please complete Table 1 with the differences between your proposed
PM and the CRP PM
Annotated PM against most recently approved PM for this generic product
dated:
(YYYY/MM/DD)
- Note: Please complete Table 2 with the differences between your proposed
PM and your currently approved PM.
a
CRP refers to the reference product listed on the NOC of the original ANDS
b
If you are filing a generic SNDS, please confirm that the original NDS was a generic approved prior to the ANDS regulations (i.e. pre-
1996) and indicate the reference product used for the approval of that generic NDS
Sponsor Attestation
S(A)NDS for Generic Drugs - Product Monograph Updates to be in
line with the CRP
Brand (Proprietary) Name of Drug Product
Drug Substance / Medicinal Ingredient
Manufacturer / Sponsor
Dosage Form(s) and Strength(s)
ab
Canadian Reference Product (CRP)
Reason for Submission
Product Monograph (PM) update based on CRP’s PM;
control number:
Product Monograph update based on another labelling reference’s PM;
control number
Please specify the product used as a reference:
Please specify the reason the CRP’s PM was not used:
Was this filed in response to
Yes - Response to Advisement letter dated:
(YYYY/MM/DD)
an advisement letter
as per CRP PM update; control number
No
Confirm that the following
The Labels and Packages Certification Form
required documents are
Annotated PM against the most recent CRP PM dated:
provided:
(YYYY/MM/DD)
- Note: Please complete Table 1 with the differences between your proposed
PM and the CRP PM
Annotated PM against most recently approved PM for this generic product
dated:
(YYYY/MM/DD)
- Note: Please complete Table 2 with the differences between your proposed
PM and your currently approved PM.
a
CRP refers to the reference product listed on the NOC of the original ANDS
b
If you are filing a generic SNDS, please confirm that the original NDS was a generic approved prior to the ANDS regulations (i.e. pre-
1996) and indicate the reference product used for the approval of that generic NDS
2 | Sponsor Attestation: S(A)NDS for Generic Drugs - Product Monograph Updates to be in line with the CRP
Notes:
- The annotated PMs, using a track changes feature or highlighting and strike-
throughs, should clearly identify all additions, deletions and replacement of
information between the proposed generic PM and the comparator PMs identified
above, and be provided as two separate documents.
- All differences must be listed in the Document Compare Tables 1 and 2 and
must have a justification (for example, update as per the reference product,
section not approved for this dosage form, level 3 change, etc.)
There are no differences between our proposed PM and the CRP PM other
Description of PM updates
(please check all that apply)
than the product brand name and product specific sections that have been
previously approved (for example, comparative bioavailability summary
table(s), pharmaceutical information, storage and stability, non-medicinal
ingredients, references).
There are some differences between our proposed PM and the CRP PM,
which have been previously approved (for example, a difference in market
authorized dosage forms, dosing and administration, strengths and/or
indications).
The CRP has been discontinued and this is a first-time update against another
reference product.
The CRP has been discontinued and another reference product has been
used for PM updates at least once previously, and this is a subsequent update
against that other reference product.
The PM is being migrated to a new format for the first time to match the CRP’s
PM.
The PM combines multiple previously approved generic PMs into one PM, to
match the CRP’s PM.
Other :
Attestation
We attest that the proposed revisions to the Product Monograph for
submitted by
contain only the changes outlined in this attestation.
We attest that the proposed revisions to the Product Monograph contain only updates to be in line with
the CRP or reference product identified above.
We attest that the proposed revisions to the Product Monograph contain all required safety updates.
Name
Signature
Title
Date
Company
2020/04/01
|
3
Sponsor Attestation: S(A)NDS for Generic Drugs - Product Monograph Updates to be in line with the CRP
Document Compare 1:
Summary of differences between proposed PM and most recent Canadian Reference Product (CRP) PM:
CRP name:
CRP PM Date:
CRP control number:
New Product Monograph Format
Differences
Justification for Differences
Part I: Health Professional
Information
Summary Product Information
Indications and Clinical Use
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions (Precautions)
Dosage and Administration
Overdosage
Action and Clinical Pharmacology
Storage and Stability
Dosage Forms, Composition and
Packaging (availability)
Part II: Scientific Information
Pharmaceutical Information
2020/04/01
|
4
Sponsor Attestation: S(A)NDS for Generic Drugs - Product Monograph Updates to be in line with the CRP
Clinical Trials
Detailed Pharmacology
Toxicology
References
Part III: Consumer Information
(Patient Information Sheet) / Patient
Medication Information
Document Compare 2:
Summary of Differences between proposed PM and most recently approved PM:
Most recently approved PM date:
Most recently approved PM control number:
New Product Monograph Format
Differences
Justification for Differences
Part I: Health Professional
Information
Summary Product Information
Indications and Clinical Use
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions (Precautions)
Dosage and Administration
2020/04/01
|
5
Sponsor Attestation: S(A)NDS for Generic Drugs - Product Monograph Updates to be in line with the CRP
Overdosage
Action and Clinical Pharmacology
Storage and Stability
Dosage Forms, Composition and
Packaging (Availability)
Part II: Scientific Information
Pharmaceutical Information
Clinical Trials
Detailed Pharmacology
Toxicology
References
Part III: Consumer Information
(Patient Information Sheet)
Patient Medication Information
2020/04/01
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