Draft guidance on the plain language labelling regulations for prescription drugs: Mock-up requirement

On this page

• From the regulations
• Purpose of this requirement
• What we review
• Note to reviewer
• Acceptable formats for DIN, expiration date and lot number
• Requirements for filing
• Mock-up requirements for other submission types
• Filing requirements for post-market changes
• Filing notifications

From the regulations

The following sections are from the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) (regulations).

Section C.01.014.1.(2) states that an application under subsection (1) shall be made to the Director in writing and shall set out the following information:

• (m.1) in the case of a drug for human use, mock-ups of every label to be used in connection with the drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the drug, and mock-ups of the drug’s packages

Section C.08.002. (2) states that a new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including:

• (j.1) in the case of a new drug for human use, mock-ups of every label to be used in connection with the new drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the new drug, and mock-ups of the new drug’s packages

Section C.08.003 (3.1) states that a supplement to a submission referred to in subsection (1) shall contain, as the case may be:

1. if, due to a matter specified in subsection (2), other than the brand name of a new drug for human use, that the supplement concerns, it is necessary to modify a new drug’s labels:
   • (ii) in the case of a new drug for human use, mock-ups of every label to be used in connection with the new drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the new drug, and mock-ups of the new drug’s packages or
2. if the supplement concerns the brand name of a new drug for human use:
   • (ii) mock-ups of every label to be used in connection with the new drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the new drug, and mock-ups of the new drug’s packages

Purpose of this requirement

Mock-ups of labels and packages are to be provided to Health Canada for review.

We assess these mock-ups to ensure that the information and design elements on the labels support the safe and effective use of drugs by patients, consumers and health care providers.

What we review

We make sure that labels comply with existing regulatory requirements on labelling.

We also review the label’s design elements, such as the:

• font size
• font type
• colour
• placement of text and graphics
  • proximity
  • overlap
  • location

Refer to:

• Good label and package practices guide for prescription drugs

Note to reviewer

Sponsors who cannot meet the requirements set out in this guidance should include a rationale (note to reviewer) in their submission. Provide the rationale as a note to reviewer in section 1.3.2.

Examples of when you should include a note to reviewer:

• to note whether there are timing constraints to generate revised mock-ups
• to confirm the contents of automated identifiers (such as barcodes, QR codes) included on mock-ups (for instance, tracking purposes, inventory)
• for novel packaging formats, a rationale for the format, including a photo or other visual representation of the novel format
• when the minimum recommended font size or type style for mock-up labels or package inserts cannot be met
• information on font sizes if the maximum and minimum font size is not included on the mock-up label(s)
• a rationale for:
  • why a placeholder for the lot number or expiry date cannot be included on the mock-ups or
  • when the expiry date format included on the mock-ups does not include the day, confirmation that the expiry corresponds to the last day of the month
• to confirm that when opaque or transparent labels are used on clear or translucent primary container closure systems:
  • the label information remains legible and
  • the label does not impede visual inspections that ensure the integrity of the product(s) before use
• to confirm the integrity of the peel-back label / butterfly label
  • the top panel remains affixed to the bottle when it is repeatedly peeled back and the legibility of the information on all layers is maintained throughout the shelf-life of the product
• if the product has a package insert and is available in multiple packaging formats, to confirm if the insert is included with all formats or only select packaging (for instance, provided with blister cartons but not with bulk bottle packaging) or if the product has more than one package insert
• when an abbreviated package insert has been filed, a rationale to support the format chosen (as described in Appendix A) and/or why recommended sections were removed
• a rationale to support a request for removal of paper package inserts
• information with respect to Division 1: Post-DIN Notification / Division 8: Level III Annual Notification and Level IV changes as per the Post NOC guidance made between submission filings including the date the notification was filed to Health Canada and the sequence

Submitting electronic mock-up labels

Submit files as a PDF (portable document format). PDFs should be:

• generated from electronic documents, not from scanned material
• editable (not locked PDF files)

Note: If a file is locked, sponsors should either indicate the font sizes of the text directly on the mock-up label or provide a summary in a note to reviewer.

For more information, check out the following guidance documents:

• Good label and package practices guide for prescription drugs
  • design of safe health product labels and packages
• Guidance document: Labelling of pharmaceutical drugs for human use
  • regulatory requirements for labelling and content of labels and packaging
• Guidance document: Product monograph
  • content and format for product monographs
  • sources of information sources on plain language labelling
• Labelling of special containers policy
  • requirements for special container types

Types of mock-ups and documents to be submitted

For prescription products and products administered or obtained from a health care professional, sponsors should submit the following:

Labelling materials

• mock-ups of inner and outer labels and packages
• mock-ups of package insert (where applicable) and
• product monograph or prescribing information (in MS Word format)

Forms

• Labels and packages certification form for prescription drugs

Documents provided within 20 days after the submission is accepted into review and/or post-authorization (within 20 days after the NOC, NOL or DIN is issued) should be:

• provided in 1 transaction and
• identified as “Second language labels pre-approval” or “Product labelling - post approval”

No other documents should be included.

The Mock-up requirements for other submission types has more information on:

• notifiable change submissions
• post-authorization Division 1 change submissions
• post-authorization Division 1 change submissions for a biologic drug
• administrative submissions

Table 1: What should be submitted and when

Labelling materials and Documents	At the time of filing	Within 20 days after the submission is accepted into review	Before the NOC, NOL or DIN is issued	Post-authorization (within 20 days after the NOC, NOL or DIN is issued)
Labels and packages certification form for prescription drugs	Completed certification form	Only if updates are required	Only if updates are required	Not applicable
Inner and outer labels	Mock-ups required Bilingual recommended A rationale for unilingual labels should be provided in a note to Reviewer if product to be marketed in 1 language only	Not applicable	Final inner and outer mock-ups	Not applicable
Product monograph (PM) If available in both official languages on the Drug Product Database (DPD) online and the Drug and Health Product Portal (DHPP)	First language PM only	Not applicable	Final first-language PM	Final second-language PM (with the date on the first and last page matching the authorized first-language document)
PM If not available or available in 1 official language only on the DPD online and DHPP	Both official languages preferred Minimum is first-language PM For administrative submissions, both official language PMs required	Second-language PM (if not already provided)	Final first-language PM	Final second-language PM (with the date on the first and last page matching the authorized first-language document)
Package inserts (PI) – PM Part I or abbreviated Part I and/or patient medication information/Part III: consumer information If PM is available in both official languages on the DPD online and DHPP, and the PI mock-up: was previously approved under the plain language labelling regulations and will match the design and layout with the last approved version once the proposed revisions are implemented	First-language PI mock-up only	Not applicable	Final bilingual or first-language mock-up	Final second-language mock-up Final first-language or bilingual mock-up only when the criteria are met
PI: PM Part I or abbreviated Part I and/or patient medication information/Part III: consumer information If 1 or more of the criteria listed in the previous row are not met	Both official languages preferred Minimum is the first-language PI mock-up	Second-language PI mock-up (if not already provided)	Final bilingual or first-language mock-up	Final second-language mock-up Final first-language or bilingual mock-up only when the criteria are met
PI: Other information such as wallet cards, warning cards and instructions for use booklet where the content is not verbatim to sections of the PM	Mock-up required Bilingual recommended A rationale for unilingual labels should be provided in a note to Reviewer if product to be marketed in 1 language only	Not applicable	Final mock-up	Not applicable

Criteria for submitting final first-language or final bilingual package insert mock-ups post-authorization (Part I or abbreviated Part I and/or patient medication information/Part III: consumer information)

In exceptional cases and when agreed upon during review, the first-language or final bilingual mock-ups may be provided post-authorization (within 20 days after the NOC, NOL or DIN is issued) when the following criteria are met:

• all text in the first language or bilingual mock-up will continue to be presented in a sans serif font type
• all text in the first language or bilingual mock-up will continue to be presented at an acceptable font size (10 points for text and 9 points for tables or a font size agreed upon during review)
• the content of this insert mock-up will include all changes made, during review, to the corresponding sections of the first-language product monograph such that the content of the first language or bilingual mock-up is verbatim to these sections of the approved product monograph/prescribing information

Table 2: Font size and type requirements for labelling materials

Labelling materials	Font size	Font type
Inner and outer mock-ups	Minimum font size is 9 points For inner labels that are either special or small containers, a minimum font size of 6 points	Sans serif font, for example: Aptos Arial Arial Bold Arial MT Standard, Regular and Bold Benton Sans, Regular and Bold Calibri Frutiger, 55 Roman and 65 Bold Helvetica Helvetica LT Standard Helvetica Neue LT Standard Univers, 55 Roman and 65 Bold
Package insert mock-up	Text should be at least 10 points Table text should be at least 9 points	Sans serif font (examples provided in this table)
Product monograph	Refer to the most recent product monograph guidance	Refer to the most recent product monograph guidance

Inner and outer label mock-ups

Mock-ups of the inner and outer labels should be bilingual, in full colour, actual size and editable (for example, PDF). Non-annotated versions of the inner and outer labels should be submitted at the time of filing. Mock-ups should contain:

• the proposed text and design elements
• all information required under the regulations
• placeholders for the DIN, lot number and expiry date using an acceptable format
• the dimensions of the labels and
• any text or designs present on the cap, vial or ferrule, if present

Changes made to previously approved labels should be provided as:

• annotated labels or
• a table summarizing the changes

Learn more:

• Labelling of special containers policy
• Guidance document: Labelling of pharmaceutical drugs for human use
• Good label and package practices guide for prescription drugs

Acceptable formats for DIN, expiration date and lot number

Drug Identification Number (DIN)

In the absence of an assigned DIN, the placeholder for the DIN should be displayed as follows: "DIN XXXXXXXX" on the mock-up.

Note: Numerical placeholders such as “DIN 00000000” should not be used.

Expiration date and lot number

Include the expiration date (for example, “EXP”, “Expiration” or “Expiration date”) on both inner and outer labels. Our preferred method is EXP 2020-JA-11. However, other acceptable formats include:

• EXP 11-JA-2020
• EXP 11-JAN-2020
• EXP 2020-JA
• EXP 2020-JAN
• EXP JA-2020
• EXP JAN-2020
• EXP 2020-01
• EXP 01-2020

When only the last day of the corresponding month is used, you may use:

• EXP 01-31-2020
• EXP 31-01-2020
• EXP 2020-01-31

Use sans serif font in minimum size of 6 points and at least 1.5 mm high. You may use dashes (-), slashes (/) or spaces to separate the date.

Place lot numbers on both inner and outer labels. Place "Lot number", "Lot No.", "Lot", "LOT" or "(L)" before the number. Keep lot numbers separate from expiry dates to avoid confusion and ensure they are not read together as 1 piece of information.

Requirements for filing

Sponsors must submit mock-ups for inner and outer labels when they file. We should receive finalized versions of labels in both official languages before we can approve a submission.

Exceptions:

• supplemental (abbreviated) new drug submissions where the proposed changes do not impact the package labels and sponsor has attested to such in the Label and Packages Certification Form for Prescription Drugs
• where the differences in the labels are only in the net contents (pill count or volume):
  • the label representing the smallest net contents must be submitted
  • sponsors must attest that the other labels will have identical text, format (including packaging components), size, layout and colour (note all minor differences), within reason

  Note: "Volume" refers to the total volume of the drug product in the container and not the expression of strength on the label

Health Canada strongly recommends that sponsors use bilingual inner and outer labels, but acknowledges that circumstances may apply when sponsors are not able to do so. In these instances, sponsors are to include a rationale along with their submission for Health Canada's review.

Professional samples

Mock-up labels for professional samples that are distributed by a health care professional to a patient must be provided if the label:

• represents the smallest net contents of the commercial labels or
• differs from the commercial labels in packaging specifications, for example:
  • dimensions of label
  • number of units in package
  • format (including packaging components) and
  • label design (for example, layout, colour, font size, style)

Note: You are reminded that a new package format and presentation are subject to the following guidance documents:

• Post-notice of compliance (NOC) changes – Quality guidance
• Guidance document: Post-drug identification number (DIN) changes

Consequently, if the change falls outside of the conditions outlined in these guidance documents for filing an annual notification (level III), a supplement may need to be filed with Health Canada.

Professional samples should:

• be labelled with the same directions required for the safe and effective use as that of the commercial trade package
• include wording prominently displayed identifying it as a sample, such as “Sample”, “Sample – Not for resale” or “Sample – Not for sale”

Note: During review, a photo (or other visual representation) or a drug free specimen of the drug product, kit or training device, may be requested.

Package insert mock-ups

Sponsors must submit the first-language or bilingual package insert in full colour, actual size with dimensions stated, when they file, if:

• a package insert exists for the product and
• the changes to the labelling proposed in the submission affect the content of the package insert
  • changes such as revisions to Part I or patient medication information or Part III: consumer information of the product monograph or prescribing information

Note: Package inserts may also include wallet cards, tear-off pads and hand-outs directed to the patient or consumer.

Learn more:

• Guidance document: Labelling of pharmaceutical drugs for human use

If a sponsor is considering an abbreviated package insert, refer to Appendix A (abbreviated package inserts) of this guidance document for recommendations.

Product monograph and prescribing information

The product monograph and prescribing information must comply with the version of the product monograph guidance and templates that apply at the time of filing.

For additional guidance, refer to:

• Guidance document: Product monograph
• Guidance document: Labelling of pharmaceutical drugs for human use

Mock-up requirements for other submission types

Post-approval safety and efficacy changes

Post-approval safety and efficacy changes to Division 8 drugs (pharmaceutical, biological and radiopharmaceutical) are to be filed in accordance with the Post-NOC Safety and Efficacy Changes Guidance Document.

This is only if the post-approval safety and efficacy changes can be filed as Level I or Level II changes, respectively, in accordance with the Post-NOC Safety and Efficacy Changes Guidance Document.

Post-approval safety and efficacy changes to Division 1 drugs (pharmaceuticals only) are to be filed in accordance with the Post-Drug Identification Number (DIN) Changes Guidance Document.

Post-approval safety and efficacy changes to Division 1 drugs (biologic and radiopharmaceutical only) are to be filed as:

• an Application for a Drug Identification Number for a biological product (DIN-B) or
• a post-authorization Division 1 Change for a biologic drug product submission (PDC-B)

Requirements for submitting mock-ups must be met, as applicable.

Refer to:

• Guidance document: Post-notice of compliance (NOC) changes: Safety and efficacy document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
• Guidance document: Post-drug identification number (DIN) changes (for pharmaceutical drugs only)

Post-approval quality changes

Post-approval quality changes for Division 8 and Division 1 biologic and radiopharmaceutical drugs can be filed as NCs and post-authorization Division 1 Change for biologic drug product submissions (PDC-Bs). This is only if the post-approval quality changes can be filed as NCs or PDC-Bs in accordance with the Post-NOC Quality Changes Guidance Document.

Post-approval quality changes for Division 1 pharmaceutical drugs can be filed as post-authorization Division 1 change submissions (PDCs). This is only if the post-approval changes can be filed as PDCs in accordance with the Post-Drug Identification Number (DIN) Changes Guidance Document.

Include the Labels and Packages Certification Form for Prescription Drugs with these submission types.

Refer to:

• Post-notice of compliance (NOC) changes – Quality guidance
• Guidance document: Post-drug identification number (DIN) changes (for pharmaceutical drugs only)

Inner and outer labels

If the labels are impacted by the updates proposed within the submission, non-annotated text versions of the proposed inner and outer label are to be submitted in both official languages at the time of filing.

For NC or PDC or PDC-B submissions, Health Canada will accept annotated written text, instead of mock-ups, to reflect proposed changes to the inner and outer labels. If you submit mock-ups instead of annotated text, we will only review the written text. Comments may not be provided on the design elements. Filing annotated text versions in the first official language will facilitate our review.

Sponsors should ensure that any proposed changes to text on the inner and outer labels do not affect design elements, which would require a Level I submission. Such changes would exceed the scope of a Level II NC or PDC or PDC‑B submission.

Package insert

Sponsors are not required to submit package inserts with NC or PDC or PDC‑B submissions.

However, you should modify the content of the package insert to reflect all applicable updates to the product monograph and prescribing information that are approved as a result of the NC or PDC or PDC‑B submission.

The proposed changes should not result in a decrease in font size or a change to the font. Such changes would be considered Level I and thus exceed the scope of a Level II NC or PDC or PDC‑B submission.

Product monograph and prescribing information

For NC or PDC or PDC-B submissions, sponsors must submit the following at the time of filing:

• clean (non-annotated) text version of the proposed product monograph/prescribing information in the first official language
• annotated version of the proposed product monograph/prescribing information in the first official language

For more information, refer to Table 1 (What should be submitted and when).

For products already approved as per the mock-up requirement, you must ensure the labels and package insert continue to comply with plain language labelling principles. This requirement applies even if you have not included a mock-up with the NC or PDC or PDC-B submission. The content of the package insert should also be kept up to date if revisions to the product monograph and prescribing information affect the package insert's text.

Administrative submissions

For submissions filed and processed under the administrative pathway, the following must be submitted at the time of filing:

• mock-ups of the inner/outer labels and packages
• mock-ups of the first and second language (or bilingual) package inserts
• first and second language product monograph/prescribing information and
• Labels and packages certification form for prescription drugs

For more information, refer to Table 1 (What should be submitted and when).

For cross-licensed products where an administrative S(A)NDS is being filed for labelling updates to match the licensor, mock-ups of the inner and outer labels and package inserts do not need to be filed if they are not affected by the change.

Learn more:

• Guidance document: Administrative processing of submissions and applications: Human or disinfectant drugs
• Guidance for industry: Review of drug brand names
• Frequently asked questions - Guidance document for industry - Review of drug brand names

Should sponsors require further direction on the eligibility under the administrative pathway or for questions, contact Health Canada:

• For pharmaceutical drugs (Administrative Submission Unit): pdd.bgivd.asu-dmp.bgmiv.usa@hc-sc.gc.ca
• For biologics and radiopharmaceuticals: brdd.ora@hc-sc.gc.ca

Filing requirements for post-market changes

The examples in the tables are not exhaustive. They are meant to provide guidance on the types of changes that are considered to be necessary to file as a Level I supplement or a notification.

Sponsors who require further direction on the most appropriate manner to file or further clarification on how to file changes that affect multiple product submissions should contact Health Canada:

• For pharmaceutical drugs: pdd.bgivd.ld-dmp.bgmiv.de@hc-sc.gc.ca
• For biologics and radiopharmaceuticals: brdd.ora@hc-sc.gc.ca

Type of change: Level I (Division 1: DINA/B labelling only submission and Division 8: S(A)NDS labelling only submission)

Post-market changes made to mock-up labels that are filed (bundled) with Level I changes that require supporting data as outlined should not be filed as DINA/B labelling only submissions or Division 8: S(A)NDS labelling only submissions.

For information on supporting data, refer to:

• Post NOC Safety and Efficacy Guidance
• Post NOC Quality Guidance Document
• Post Drug Identification Number Changes (PDC) Guidance Documents

Criteria:

• content changes to ensure labelling adheres to the requirements in the Food and Drug Regulations and associated guidance or to comply with changes requested by Health Canada
• content changes to make the text more plain language that do not require supporting data
• post-market changes made to mock-up label design elements and to the layout that impact the design and layout of the labels, create clutter, reduce the overall legibility and readability of the label or significantly reduces the ratio of white space to text
• post-market changes to the visibility, prominence or legibility of the information (contrast, colour coding, intensity or value)
• creation of a package insert or a significant change to the contents or design of the package insert
• any changes to small or special containers as outlined in Sections 3.6.2 and 3.6.3 of the Labelling of Prescription Drugs for Human Use Guidance Document and the Labelling of Special Containers Policy other than the examples noted in the tables as notifications
• multiple Level III changes that lead to a significant re-design of the label

Type of change: Notifications (Division 1: Post-DIN notification / Division 8: Level III annual notification)

Criteria:

• post-market changes that apply to non-regulatory information (other than the examples in the tables) or to information that was not approved for the safe use of the product or as a risk mitigation measure
• post-market changes made to mock-up label design elements and the layout that do not negatively impact their legibility and readability, such as:
  • not significantly reducing white space or creating clutter
  • having a minimal impact on the label’s design, layout, legibility and readability
  • not displacing approved regulatory text
  • not causing the removal of safety information
  • meeting the minimum font sizes recommended by this guidance

Table 3: Examples of changes for outer, inner and package mock-ups

Type of change	Level I (Division 1: DINA/B labelling only submission / Division 8: S(A)NDS labelling only submission)	Notifications (Division 1: Post-DIN notification / Division 8: Level III annual notification)
General changes	A change to any of the components appearing on the principal display panel where: revisions to the colours used to identify key product characteristics (for example, brand name, strength, trade dress) as outlined in section 3.4.1 of the Good Label Package Practices Guide for Prescription Drugs (GLPPG for Prescription Drugs) prominence of drug information to aid in its identification has been diminished including a reduction in font size of the information Adding or changing the number of units (for example, pre-filled syringes, ampoules, vials, autoinjectors, cartridges, nasal sprays, inhalers) in a new or existing carton	A change to the visual appearance (look and feel) of the label: change to the colour of a blister foil as long as there is sufficient contrast between the background and text, the legibility is maintained and the requirements in the GLPPG for Prescription Drugs are met (for example, hue, saturation) change to the background colour of the blank area where the lot number and expiry date are printed as long as there is sufficient contrast between the background and text and legibility is maintained (for example, changing from a white background with black text to a black background with white text) change to artwork layout (for example, 2‑blister sheet layout to a 4‑blister sheet layout) when there is no change to the material of construction, individual blister unit dimensions and text (except for specific site codes), total unit count per pack, and location of text and font size and type used change from a serif font to a sans serif font
Change in the package design	Moving from a 1-ply label to a peel-back or butterfly label or vise versa A decrease in font size or a change in font style (for example, condensed, compressed, horizontally scaled, expanded, italicized font)	Moving from an existing approved 2-ply label to a 3-ply label only if as the approved information and design/layout on the top layer panels are retained; and limited to contents being relocated between the secondary and newly added ply layers A change in tablet marking to an existing approved image on the label to align with the revisions made to the PM and/or package insert that were implemented and filed as a Notification as per the Post NOC- Quality Guidance / Post DIN Guidance Replacing the company logo with existing DIN holder's name in text only Changes to product trademark symbols ("TM" to "®") or statements Moving the information (for example, strength) left, right, up and down by a few millimeters to accommodate a die line to avoid cutting the text Removing an additional panel or flap (for example, 5th panel) where the information is a duplicate of another panel as long the information being removed is found on another panel and does not include the removal of any safety information only found on this panel
A change in the overall layout	A change in the overall layout of the mock-up (horizontal to vertical, vertical to horizontal) A change to the approved information printed on each blister cell or across cells where the change impacts the legibility of key information after the removal of multiple doses Reducing the overall label dimension which reduces the legibility or affects the positioning of regulatory information	Moving non-regulatory information (for example, trademark statement) from 1 panel to another or reducing the font size of non-regulatory information to less than 6 points Moving regulatory text not required to be on the main panel (for example, manufacturer’s name and address, therapeutic class) to another panel as long there is no change to font size or type or significant changes to layout to the panel where the information has been moved and it does not compromise the safe use of the drug Switching within secondary panels (for example, the left and right or top and bottom) with no other design or content changes Deleting duplicate information from secondary panels (that is, brand name, proper or common name, strength (including any text boxes) and company name or logo) Switching the location of the expiry and lot number from 1 panel to another A change in expiry date format, expiry and lot number descriptors to an acceptable format identified in this document Changes in printing direction from horizontal to vertical text and vice versa when the change only applies to the printing direction of non-regulatory information (for example, product code, logo, trademark information) or to the lot number and expiry date information as long as existing location, amount of white space and descriptors are maintained Blister foil labels where the approved text is displayed randomly is revised where the information is displayed on each individual blister cell and meets minimum font size requirements Decreasing the font size of the lot and expiry descriptors to not less than 6 points Adding the lot number and expiry date to each blister cell when the font size of the lot number and expiry date is not less than 6 points Adding a designated placeholder for a pharmacy label as long as it does not overlap or impede Health Canada-approved information
Electronic links or codes	Adding an electronic link (quick response (QR) code, 2D matrix code or website) to a small or special container labels (for example, 1 mL and 2 mL vial/ampoule) that decreases the font size of the lot number and expiry date placeholders to lower than 6 points	Adding or updating an electronic code (for example, quick response (QR) code, 2D matrix code, website, technical codes or other inventory tracking codes): strictly for product traceability purposes (that is, does not link to drug product information) including for labels approved under the small or special container policy as long as it does not decrease the font size of the approved information to less than 6 points that leads only to approved Health Canada labelling information (for example, product monograph, package insert) if the barcode is hosted on the DIN holder’s (manufacturer’s) website, and the barcode meets the criteria listed for filing a notification and does not replace an existing physical copy of the package insert
Graphics, logos, symbols	Adding or changing the location or increasing the size of a graphic Adding or removing symbols that ensure the safe use of the product (for example, cytotoxic) Adding graphic or text to the label that describes a novel or modified formulation (for example, “New/Nouvelle Formulation”) including the graphic or text is acceptable for 1 year of product sale Adding an importer or distributor logo or replacing the manufacture (DIN owner) logo with an importer or distributor logo where the new logo has not been previously approved and does not meet the conditions to be filed as a notification	Removing or changing graphics (for example, registered trademark symbols, brand name logo), including changing the colour or reducing the size of the graphic or logo not appliable to symbols required by the regulations Replacing the company logo with existing DIN holder's name in text only Changing product trademark symbols ("TM" to "®") or statements Removing “new” graphic or text to describe a novel or modified formulation after 1 year of product sale Adding an importer or distributor logo that has been previously approved or is composed of scripted text only (no imagery) as long as the logo is displayed on a secondary panel, the information is accompanied by business information of the importer or distributor, is less prominently displayed than the manufacturer’s (DIN owner) logo (if included) and does not distract or impede information on the label Adding the Forest Stewardship Council (FSC) logo and/or recycling logo on a secondary panel as long as it is not prominently displayed and does not distract from the critical information
Changes to text	Changes to regulatory content on the labels Adding second-language information: where information already appears on the label, the removal of a unilingual side panel and the creation of a bilingual side panel Removing information from the label related to the components of a kit Applying TALLman lettering (that is, capitals) to the non-proprietary name	Correcting spelling, translation errors or minor editorial changes: change in the spelling of a common name to match the spelling as per the INN (for example, “alpha” to “alfa”) replacing a dash (-) with the word “to” revising the therapeutic class on package labels to match the PM updating the standard of manufacturing as per the Post NOC (Quality) Guidance updating information to reflect most current Health Canada online resources Updating contact information: updating contact information, including adding the "questions or concerns" statement mentioned in the contact information section of this guidance removing distributor information on the label, as long as the DIN holder (manufacturer) is in Canada or updating the distributor information on the label changes to the company, importer, distributer address on the package labels to match the title page of the PM Increasing the font size of the last 5 digits of the DIN (for example, DIN xxxXXXXX) Increasing the font size to meet the minimum font size in this document provided that all other contents, white space and design elements (such as layout, font, colour) are not affected Reducing the prominence of the strength per milliliters as long as the total strength per total volume is presented on the labels (to align with GLPPG for Prescription Drugs recommendations) Updating text on the package label to reflect the titles of Health Canada's consumer information or patient medication information leaflet to correspond to the titles in the sponsor's approved product monograph Including a clinically relevant NMI (for example, lactose) on package labels when listed in the PM Changing the naming convention of the NMI (for example, succinate buffer vs. succinic acid) when consistent with the PM Removing references of components no longer enclosed as part of the packaging and not referenced in the PM (for example, alcohol wipes) Removing the standard of manufacture from inner and outer package labels
Changes to the ratio of white space to text	Changes to the principal display panel (product name (proprietary and non-proprietary), DIN, expression of strength, dosing, route of administration, population and storage) where there is a reduction in font size	Increasing overall label dimensions such that there are no other changes to font, graphics, or ratio of white space to text and the legibility of the label is not affected Increasing the font size of the information when there is an increase in the label dimensions (that is, proportional change) Increasing the font size to meet the minimum size outlined in this document provided that all other contents, white space and design elements (such as layout, font, colour) are not affected Decreasing the white space between English and French text when presented on the same panel as long as there are no changes to font size and type and content

Table 4: Examples of changes for package insert mock-ups

Type of change	Level I (Division 1: DINA/B labelling only submission / Division 8: S(A)NDS labelling only submission)	Notifications (Division 1: Post-DIN notification / Division 8: Level III annual notification)
Design and layout	Creation of a package insert or a significant change to the contents or design of the package insert Removal of a paper package insert	Reducing the dimensions of the package insert but not decreasing font size or changing font style. The existing text should not be replaced with condensed, compressed, horizontally scaled, expanded or italicized font styles. The order of the contents should not be changed Increasing the dimensions of the package insert that leads to an increase in font size with the use of a sans serif font that is not condensed, compressed, horizontally scaled, expanded or italicized Changing page orientation from portrait to landscape and vice versa, but order of the contents is maintained Changing the physical location of the insert (from a sidesert to topsert) as long as it does not impede the information on the label
Changes to text	A change to the content where: a second language package insert is created there is a change from a package insert consisting of Part I (full or abbreviated) of the PM to or from a patient medication information (PMI) a PMI is created where one did not exist for an existing dosage form leading to a change to the package insert content there is a change to the sections included in an abbreviated package insert there is an update or inclusion of new images or illustrations to promote its proper or safe use to align with the revisions made to the PMI	Correcting spelling, translation errors or minor editorial changes Minor editorial changes, including clarifying instructions (for example in an IFU) when consistent with the approved PM

Filing notifications

For Division 8 drugs:

• Submit a Level III change at the time the change is implemented or submit during the annual drug notification period depending on the type of drug (pharmaceutical or biologic or radiopharmaceutical) and the type of change (quality or safety and efficacy).
• Submit all Level III changes using the Post-Notice of Compliance (NOC) Changes: Level III change form.
• Choose "other" in the dropdown list of this form and use the free text to provide details of the Level III change you are making.

Learn more:

• Section 2.1.4 Level III – Annual notifications of the Guidance document: Post-notice of compliance (NOC) changes: Framework document (pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
• Guidance document: Post-notice of compliance (NOC) changes: Safety and efficacy document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
• Post-notice of compliance (NOC) changes – Quality guidance
• Level III changes form

For Division 1 drugs: 

• For pharmaceutical drugs: For notification of label changes for Division 1 drugs, submit a Post-DIN notification to the Office of Submissions and Intellectual Property (OSIP) within 30 days of making the change.
• For biologic drugs and radiopharmaceuticals: For notification of a label change for Division 1 drugs, filed at the time the change is implemented using the Post-Notice of Compliance (NOC) Changes: Notice of Change - Level III Form.

Learn more:

For pharmaceutical drugs:

• Guidance document post-drug identification number (DIN) changes

For biologic drugs and radiopharmaceuticals:

• Section 2.1.4 Level III – Annual notifications of the Guidance document: Post-notice of compliance (NOC) changes: Framework document (pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
• Guidance document: Post-notice of compliance (NOC) changes: Safety and efficacy document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
• Post-notice of compliance (NOC) changes – Quality guidance
• Level III changes form