"Labels and Packages Certification Form for Non-prescription Drugs" - Canada

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Protected A (When Completed)
Labels and Packages Certification Form for Non-prescription Drugs
Drug Product Information
Submission Type
Brand, Proprietary or Product
Name
(as per Field #8 on the Drug
Submission Application Form)
Proper, Common or Non-
proprietary Name
(as per Field #9 on the Drug
Submission Application Form)
Note: This Labels and Packages Certification Form outlines the requirements as per Health
Canada's Guidance Document, Questions and Answers: Plain Language Labelling
Regulations for Non-prescription Drugs (Q&A: PLL).
Attestation
Attestation A*: New Drug Submission (NDS), Abbreviated New Drug Submission (ANDS),
Supplement to a New Drug Submission (SNDS), Supplement to an
Abbreviated New Drug Submission (SANDS), Application for a
Drug Identification Number (DINA)
Attestation B*: Post-Authorization Division 1 Change (PDC)
Attestation C: Submissions Processed Administratively
*Does not include submissions processed administratively. For those submissions, please use Attestation C.
Protected A (When Completed)
Labels and Packages Certification Form for Non-prescription Drugs
Drug Product Information
Submission Type
Brand, Proprietary or Product
Name
(as per Field #8 on the Drug
Submission Application Form)
Proper, Common or Non-
proprietary Name
(as per Field #9 on the Drug
Submission Application Form)
Note: This Labels and Packages Certification Form outlines the requirements as per Health
Canada's Guidance Document, Questions and Answers: Plain Language Labelling
Regulations for Non-prescription Drugs (Q&A: PLL).
Attestation
Attestation A*: New Drug Submission (NDS), Abbreviated New Drug Submission (ANDS),
Supplement to a New Drug Submission (SNDS), Supplement to an
Abbreviated New Drug Submission (SANDS), Application for a
Drug Identification Number (DINA)
Attestation B*: Post-Authorization Division 1 Change (PDC)
Attestation C: Submissions Processed Administratively
*Does not include submissions processed administratively. For those submissions, please use Attestation C.
2 | Labels and Packages Certification Form for Non-Prescription Drugs
Attestation A – NDS, ANDS, SNDS, SANDS, DINA
I, the undersigned, certify, in regards to all original and solicited information, that:
Inner and Outer Label and Package Mock-Ups
At time of filing:
(select one option)
All inner and outer label and package mock-ups associated with this product are enclosed in
both official languages.
Any necessary clarifications should be provided within a Note to Reviewer in Module 1.3.2.
Written text of all inner and outer labels and packages associated with this product has been
enclosed in both official languages.
Note: Depending on the type of submission, a Screening Deficiency Notice (SDN) or a Notice of
Deficiency (NOD) will be issued requesting finalized versions of inner and outer label and package
mock-ups in both official languages.
A mock-up of only the smallest label and/or package for each dosage form and strength has
been provided in both official languages, as
• there are no differences other than pill count or volume on the labels/packages; and
• all the other labels/packages will have identical text, format, size, layout, color, etc.
Any minor differences have been clearly cited within a Note to Reviewer in Module 1.3.2.
Inner and outer label and package mock-ups are not required for this submission (i.e., the
proposed changes do not impact the labels).
If labels have been provided, I certify the following (as per Health Canada’s Guidance
Documents, Q&A: PLL Regulations for Non-prescription Drugs and the Labelling
Requirements for Non-prescription Drugs, and the Good Label and Package Practices
Guide for Non-prescription Drugs and Natural Health Products (GLPPG)).
The second language translation of the enclosed inner and outer label and package mock-ups
is, to the best of my knowledge, true and accurate.
Finalized bilingual version of the inner and outer label and package mock-ups, will be
submitted prior to approval.
The enclosed inner and outer label and package mock-ups
are in an editable (i.e., not locked) PDF format. The mock-ups are full colour and actual
size, with the dimensions for each label stated (dimensions can be indicated directly on the
mock-ups, or within a Note to Reviewer in Module 1.3.2).
2020-04-01
3 | Labels and Packages Certification Form for Non-Prescription Drugs
The font size and style of the enclosed inner and outer label and packages
meet the requirements outlined in the Guidance Document: Labelling Requirements for
Non-prescription Drugs and the Good Label and Package Practices Guide for Non-
prescription Drugs and Natural Health Products (GLPPG).
Product Monograph/Prescribing Information
At time of filing:
(select one option)
The Product Monograph/Prescribing Information is enclosed in both official languages.
The first language Product Monograph/Prescribing Information has been provided and the
second language Product Monograph/Prescribing Information will be provided within 15 days
of the submission being accepted into review.
The Product Monograph/Prescribing Information is not required for this submission (i.e., the
proposed changes do not impact the Product Monograph/Prescribing Information).
If a Product Monograph/Prescribing Information has been/will be provided, I certify the
following (as per Health Canada’s Guidance Document, Q&A: PLL Regulations for Non-
prescription Drugs):
The second language translation of the Product Monograph/Prescribing Information is/will be,
to the best of my knowledge, true and accurate.
A finalized second language translation of the Product Monograph/Prescribing Information that
has been updated with any changes made during review and is, to the best of my knowledge,
true and accurate, will be submitted no later than 20 days following approval.
Package Insert Mock-Up(s)
Please check the option that best describes the content of the Package Insert for this product:
Product Monograph Part III/Consumer Information
Product Monograph Patient Medication Information
Other (e.g., Package Insert for Division I products if applicable)
This product does not have a Package Insert
At time of filing, if a Package Insert exists for this product:
(select one option)
A mock-up of the Package Insert is enclosed in both official languages.
2020-04-01
4 | Labels and Packages Certification Form for Non-Prescription Drugs
Written text of Package Insert is enclosed in both official languages.
Note: A Screening Deficiency Notice (SDN) will be issued requesting finalized versions of inner and
outer label and package mock-ups in both official languages.
The first language Package Insert mock-up (Part III of the Product Monograph only) has been
provided and the second language Package Insert mock-up will be provided within 15 days of
the submission being accepted into review.
The first language Package Insert written text (Part III of the Product Monograph only) has
been provided and the second language Package Insert written text will be provided within 15
days of the submission being accepted into review.
Note: A Notice of Deficiency (NOD) will be issued requesting finalized versions of inner and outer label
and package mock-ups in both official languages.
A mock-up of the Package Insert is not required for this submission (i.e., the proposed
changes do not impact the Package Insert).
If a Package Insert has been/will be provided, I certify the following (as per Health
Canada’s Guidance Document, Q&A: PLL Regulations for Non-prescription Drugs):
The second language translation of the Package Insert mock-up is/will be, to the best of my
knowledge, true and accurate.
The content of the Package Insert matches the content of the Product Monograph.
A finalized first language (or bilingual) Package Insert mock-up, reflecting all applicable
revisions that have been requested to the
Product Monograph/Prescribing Information
throughout review
will be submitted
prior to approval.
,
If a bilingual Package Insert is not provided prior to approval, a finalized second language
translation mock-up of the Package Insert that has been updated with any changes made
during review and is, to the best of my knowledge, true and accurate, will be submitted no
later than 20 days following approval.
The enclosed Package Insert mock-up
is in an editable (i.e., not locked) PDF format. The mock-up is full colour and actual
size, with the dimensions stated (dimensions can be indicated directly on the mock-up, or
within a Note to Reviewer in Module 1.3.2).
The font size and style of the enclosed Package Insert
meet the requirements in the Guidance Document: Labelling Requirements for Non-
prescription Drugs and the Good Label and Package Practices Guide for Non-
prescription Drugs and Natural Health Products (GLPPG).
2020-04-01
5 | Labels and Packages Certification Form for Non-Prescription Drugs
Attestation B – PDC
I, the undersigned, certify, in regards to all original and solicited information, that:
Inner and outer label and package text
At time of filing:
(select one option)
Written text of all inner and outer labels and packages associated with this product has been
enclosed in both official languages.
Any necessary clarifications should be provided within a Note to Reviewer in Module 1.3.2.
Written text of the inner and outer labels and packages is not required for this submission (i.e.,
the proposed changes do not impact the labels).
For Division 1 products approved prior to PLL Regulations using any graduated flexibilities, all
inner and outer label and package mock-ups associated with this product are enclosed in
both official languages (for compliance with PLL regulations only).
If written text labels have been provided, I certify the following (as per Health
Canada’s Guidance Document, Q&A: PLL Regulations for Non-prescription Drugs):
The second language translation of the enclosed inner and outer labels and packages is, to
the best of my knowledge, true and accurate.
Finalized bilingual version of the inner and outer labels and packages text will be submitted
prior to approval.
Product Monograph/Prescribing Information
At time of filing:
(select one option)
The revised Product Monograph/Prescribing Information is enclosed in both official languages.
2020-04-01
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