plain language labelling (pll) requirements

Plain Language Labelling (PLL) Requirements

CAPRA Symposium November 17, 2016

Veronica Yip

Manager, Labelling Division Therapeutic Products Directorate

Outline • What is the Plain Language Labelling (PLL) Initiative? • Amendments to the Food and Drug Regulations

– General Plain Language Provision – Brand Name Assessment – Company Contact Information – Drug Facts Table – Mock-up of Labelling Materials

• Implementation PLL in TPD – Guidance Document: Questions and Answers: Plain Language Labelling (PLL)

Regulations – Good Label and Packages Practices Guide (GLPPG) for Prescription Drugs – Application of the GLPPG during the Review of Mock-Up Labels – Principles to Consider when Designing Clear and Legible Labels – Progress Made to Date and Best Practices

• References • Questions

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What is the Plain Language Labelling (PLL) Initiative? • Changes to the Regulations and policy affecting

prescription and non-prescription drugs, and biologics

• Purpose is to reduce preventable drug harms and support the safe and effective use of drugs by: – Making improvements to ensure health product

labels are clear, accurate, and easily understandable;

– Minimizing opportunities for confusion with labels, packages or names

• Government of Canada priority – Referenced in the 2013 Speech from the Throne

• Implementation: – New requirements will be expected for submissions

that are filed on or after the coming into force date. – Not intended to be applied retroactively (i.e., will

not be applied for submissions already in the queue)

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Coming into Force dates:

June 13, 2015

For prescription, ethical/professional

drug products

June 13, 2017 For non-prescription

drug products

Amendments to the Food and Drug Regulations: General Plain Language Provision Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) state that: A.01.017 Every label of a drug for human use in dosage form shall meet the following conditions: (a) the information that is required by these Regulations to appear on the label shall be

(i) prominently displayed on it, (ii) readily discernible to the purchaser or consumer under the customary conditions of

purchase and use, and (iii) expressed in plain language; and

(b) the format of the label, including the manner in which its text and any graphics are displayed on it, shall not impede comprehension of the information referred to in paragraph (a).

• Supports all other requirements being introduced

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Amendments to the Food and Drug Regulations: Brand Name Assessment • Requirements outlined in C.01.014.1(2) (o)(i)(ii)(iii), C.08.002(2)(o)(i)(ii)(iii) and

C.08.003(3.1) • Obligation to provide evidence that a drug will not be confused with another

drug because of similar names. • Supporting Documents:

– Guidance for Industry: Review of Drug Brand Names • Replaces 2006 Guidance for Industry - Drug Name Review: Look-alike Sound-alike (LA/SA)

Health Product Names • Applies to:

– Pharmaceutical prescription drugs – Schedule D products (e.g., Biologics) – Schedule C products (e.g., Radiopharmaceuticals, kits) – Drugs that are sold to the general public with the intervention of a healthcare

professional, usually a pharmacist – Drugs that are sold directly to healthcare professionals and are intended for

professional use. (e.g., anaesthetics) (A separate brand name assessment framework will be developed for non-prescription (over-the-counter) products and natural health products).

• Accompanying Frequently Asked Questions - Guidance Document for Industry - Review of Drug Brand Names

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Amendments to the Food and Drug Regulations: Company Contact Information • Requirements for both inner and outer label and package outlined in

C.01.004.01(1) (a), (b) , C.01.004.01(2) • Intended to ensure that users are given information on drug labels that will

allow them to report problems or adverse reactions, or have a question or concern.

• Requirement to provide in both official languages, at least one method of contacting the person in Canada. – Providing the information by just one of these means (e.g. toll-free number,

email address, website) would be considered sufficient. – A toll-free number, email address or website are the recommended means of

contact. • In cases where there is limited spacing on a package label, sponsors may

wish to use their postal address to satisfy both the new PLL (C.01.004.01(1) ) and the existing regulation (C.01.004.1(c)(i)) requirements. 6

Amendments to the Food and Drug Regulations: Drug Facts Table • Requirements applicable to non-prescription

drugs only, outlined in C.01.004.02 (1) • Comes into force on June 13, 2017. • Standardization of the format for non-

prescription drug labels in a table to help users find and understand important information

• NNHPD lead • For more information on the Drug Facts

Table, please see section 2.4.4 of the Good Label and Package Practices Guide for Non-prescription drugs and Natural Health Products

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Amendments to the Food and Drug Regulations: Mock-Up of Labelling Materials • Requirements outlined in C.01.014.1.(2), C.08.002. (2), and C.08.003 (3.1)

• Obligation to submit full colour actual scaled mock-ups of labelling

materials that will be accurate representations of what will be made available on the market instead of written text of every label – Mock-up inner and outer labels, – Mock-up Packages, – The Product Monograph, and – Mock-Up Package Inserts

• Stronger emphasis on the labels in both languages

• Significant changes exclusively to the label and package authorization

(post-NOC and post-DIN changes) will also require the submission of a label and package mock-up – Filed as S(A)NDS – Labelling only submissions.

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Amendments to the Food and Drug Regulations: Mock-Up of Labelling Materials (continued…)

• In connection with the mock-up requirements, the Regulations repeal the requirement at C.01.014.3 to submit final labels after the drug is available for sale.

• Final review of the inner and outer mock-up labels (assessing design elements and regulatory label information) required before the Notice of Compliance (NOC) or DIN/DIN Application Approval Letter can be issued.

• Supporting Documentation: – Good Label and Package Practices Guide for Prescription

Drugs (final version published on June 30, 2016) – Product Monograph Guidance and Template – Guidance Document: Questions and Answers: Plain

Language Labelling Regulations – Post-NOC Changes (Safety and Efficacy)

• Mock-up Labels and Packages Certification Form to be

included with the submission at the time of initial filing.

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Implementation of PLL: Guidance Document: Questions and Answers: Plain Language Labelling (PLL) Regulations

• Provides information how Health Canada’s Health Products and Food Branch interprets and applies the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) for prescription products and those administered or obtained through a health professional • Outlines requirements for (A)NDS and S(A)NDS, and

Administrative submissions • Mock-up Labels and Packages Certification Form

requirement • Recently updated on September 8, 2016

• This document does not address implementation for

non-prescription products.

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http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/index-eng.php

Implementation of PLL: Guidance Document: Questions and Answers: PLL Regulations (continued…)

• Latest version effective September 8, 2016

• Updated requirements for the submission of 2nd language documents

• Reorganization of the sections related to mock-up requirements

• Removal of requirement to submit mock-up labels and a mock-up package insert for Notifiable Change (NC) or Post-Authorization Division 1 Change (PDC) submissions.

• February 2, 2016 - Updates to the Guidance Document; Question and Answers: Plain Language Labelling Regulations

• Mock-up Labels and Packages Certification form is being revised as referenced in this presentation.

• Inclusion of text on the recommended font sizes for labelling materials.

• Additional requirement to declare font size and style for labels and to provide a rationale, if expected font size is not met.

• Addition of guidelines on abbreviated package inserts added as an Appendix.

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Requirements for the submission of 2nd language documents


Requirements for Inner/Outer Label and Package Mock-Ups

(S)(A)NDS, DINA

• Submit a Mock-up Labels and Packages Certification form • Bilingual mock-ups should be representative of the package:

– Full colour and actual size (to-scale) for all packaging presentations • All sides of the package should be visible, including the cap and ferrule, if present

– Includes dimensions on the labels – Confirm font size and style; and provides a rationale, if expected font size is not met. – Includes proposed text

• Lists placeholders for lot number, expiry date, and DIN, and their descriptors (e.g., EXP, LOT) and format (e.g., YYYY/MM/DD)

• Provide as an electronic Portable Document Format (PDF) that is not locked and from not scanned material

• Submit mock-up of only the smallest label and/or package for each dosage form and strength if: – 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.

• Annotated versions in the first official language may be requested in order to facilitate review. • Finalized labels in both official languages are required prior to approval. • Label mock-ups are required for all submissions proposing changes to the labelling, including those filed

under the Change to Product and/or Manufacturer Name policy.

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Requirements for Inner/Outer Label and Package Mock-Ups (continued…)

NCs/PDCs

• Submit a Mock-up Labels and Packages Certification form

• If labels are impacted by the updates proposed within the submission, clean (non-annotated) text versions should be submitted at the time of filing in lieu of mock ups.

• Annotated written text may be submitted to reflect proposed changes to the inner/outer labels.

• Sponsors should ensure that any proposed changes to the inner/outer label and package text do not inadvertently result in Level I design element label changes, as described in Heath Canada’s Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document.

– The proposed text changes should not result in a decrease in font size or change to font style of the Package Insert text. Such changes would be considered Level I changes.

• Finalized labels in both official languages are required prior to approval.

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Package Inserts

(S)(A)NDS, DINA

• Submit a Mock-up Labels and Packages Certification form • A package insert mock-up is to be submitted at the time of filing if:

• a package insert exists for this product

• The changes to the labelling proposed within the submission affects the contents of the package insert

• When filed, it should be a full colour, actual size mock-up submitted in an electronic Portable Document Format (PDF) that is not locked (i.e., not from scanned material)

• Non-annotated version is required to assess the content and design elements of the Package Insert for legibility.

• Annotated versions in the first official language may be requested in order to facilitate review.

• Filed as a stand alone document even if its contents are identical to the Patient Medication Information/Consumer Information section (or other sections) of the Product Monograph

• Accompanied by an attestation that the content of the package insert matches the content of the PM.

• 2nd language mock up (if not provided at filing) is required 15 days after acceptance into review.

• Addition of guidelines on Abbreviated Package Inserts added as an Appendix. • Finalized 1st language (or bilingual) Package Insert mock-up is required prior to approval and should reflect all

applicable revisions that have been requested to the Product Monograph/Prescribing Information throughout the review.

• Sponsors are to file the 2nd language Package Insert no more than 20 days after NOC issuance.

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Package Inserts (continued…)

NCs/PDCs


• Package Inserts are not required with NC or PDC submissions.

• If a Package Insert is submitted: – the content of the Package Insert should be modified to reflect all applicable updates to the

Product Monograph/Prescribing Information that are approved as a result of the NC or PDC submission.

– Attestation that the content of the package insert matches the content of the PM.

• The proposed changes should not result in a decrease in font size or change to font style of the Package Insert text. Such changes would be considered Level I changes.

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Product Monograph

(S)(A)NDS, DINA • Submit a Mock-up Labels and Packages Certification form

• At the time of filing, submit an annotated and non-annotated 1st language proposed PM (in Word and pdf)

• 2nd language PM (if not provided at filing) is required 15 days after acceptance into review.

• Only a non-annotated, pdf version is required

• Sponsors are required to attest to the fidelity of translation

• Sponsors are to file the 2nd language PM no more than 20 days after NOC issuance

NCs/PDCs

• Submit a Mock-up Labels and Packages Certification form • At the time of filing, submit an annotated and non-annotated 1st language proposed PM • 2nd language PM (if not provided at filing) is required 15 days after acceptance into review • Sponsors are to file the 2nd language PM no more than 20 days after NOL issuance

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Administrative Submissions


• Eligibility criteria under the Change to Product Name and/or Manufacturer’s Name Policy.

• Filing of first and second language (or bilingual) labelling materials

• For submissions processed administratively, if there are any significant changes made to the label design elements, the submission can no longer be processed administratively and a Labelling-only submission needs to be submitted. The administrative changes will be reviewed as part of the Labelling-only submission.

• For instance, if Sponsors want to change the location or size of graphics or font of their label, they will need to file a Labelling-only submission.

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Post-Notice of Compliance Changes / Post-Drug Identification Number Changes

• Post-market changes made exclusively to the label layout and design elements require the submission of the label and package mock-ups and should be filed as S(A)NDS/DINA Labelling only submission.

S(A)NDS/DINA Labelling only submission. • The label text information should remain the same as in the previously approved label. • Sponsors should be providing the clean mock-up labels.

– Annotated labels may be provided to facilitate timely screening and review. • Example of S(A)NDS Labelling-only submissions:

– Addition of new graphics/symbols or changing the location of graphics on the inner/outer label; – Changing the size of colour of text or background in connection with product name, warnings,

dosage, etc; – Reordering text on the label necessary for the safe and effective use of the product; – Reducing overall label size; – Changing the package design, where the package is the immediate container; – Increasing the size of the company logo/graphics; – In response to a Health Canada-issued advisement letter specifically soliciting a Labelling-only

S(A)NDS.

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Post-Notice of Compliance Changes / Post-Drug Identification Number Changes

• Any Level III changes that have been implemented should be clearly marked as such, and annotated in the affected documents with the filing of the next submission to Health Canada.

• Changes should be submitted using the Level III change form at the time the changes are made.

• Examples of Level III changes:

– Updating bar codes and technical codes;

– Removing graphics;

– Removing non-regulatory label information;

– Changing colour of graphics where there is no text overlay or changing colour of company logo;

– Correcting spelling errors;

– Updating contact information on the label.

• The Level 1 and Level 2 list provided in these slides are not exhaustive. Sponsors are encouraged to contact Health Canada should they require further direction on the most appropriate manner to file.

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Mock-up Labels and Packages Certification form Purpose is to certify:

1) the fidelity of translation; 2) the commitment to provide the 2nd language PM and/or Package Insert

documents within the first 15 days after the submission has been accepted into review;

3) the commitment to update the 2nd language PM and/or Package Insert with any applicable changes made during the PM review process;

4) the commitment to file the 2nd language version of the final approved PM and Package Insert no later than 20 days following the date of issuance of the NOC, NOL, DIN;

5) the font size and type style of the mock-up labels; 6) the font size and type style of the Package Insert; 7) the content of the 1st and 2nd language Package Inserts.

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Implementation of PLL in TPD: Good Label and Packages Practices Guide (GLPPG) for Prescription Drugs

• Supports the implementation of the Plain Language Labelling (PLL) initiative • Regulations Amending the Food and Drug Regulations

(Labelling, Packaging and Brand Names of Drugs for Human Use)

• Outlines the principles of design for safe labelling

and packaging of health products for human use

• Draft published on March 3, 2015 • Single Guide for Prescription and Non-Prescription Drugs

• Final Guides published on June 30, 2016 • Prescription Drugs • Non-Prescription Drugs and Natural Health Products

• Label Information: • Key elements on the

principal display panel • Expression of Strength • Critical Warnings • Expiry date • Lot Number • Automated identification

(e.g., bar codes)

• Packaging: • General Considerations • Small Containers / Small

Volume containers • Pediatric products • Blister packaging • Transdermal packaging

Implementation of PLL in TPD: Application of the GLPPG for Prescription Drugs during the Review of Mock-Up Labels

• Design and Layout: • Text / Type Style (font),

text size • TALLman lettering • Proximity and

Compatibility • White Space • Colour and Contrast • Use of abbreviations,

symbols and dose designations

• Bilingual Labelling • Logo / Branding • Permanence

Provides direction to sponsors to help them

design clear, legible labels and packages that

comply with the PLL Regulations.

Applies to: • Prescription drugs; • Biologics and

radiopharmaceuticals; and

• Products administered or obtained through a healthcare professional.

Suggests ways to improve product labels to assist end

users in product identification, selection,

dispensing, and administration of the

appropriate medication, strength, and dose.

Design and Layout: Text, Type Style (font), Size

• Legible Type Style is used and size facilitates readability for end-users • Sans Serif font that is not compressed,

expanded or decorative

• Avoid use of all capital letters except where warranted (e.g., headings and warnings) and its use does not reduce legibility or adversely affect readability.

• Non-proprietary name, at a minimum, is half the size used for the brand name

• Important information is highlighted by contrasting characteristics (e.g., type size, weight, colour and spacing) DRAFT

Type Style: Sans Serif (not compressed) Sans Serif (compressed) S a n s S e r i f (expanded)

TPD’s Recommended Font Size:

Point size 10: • Part III: Consumer Information / Patient

Medication Information • Package Inserts (Part I of the Product

Monograph; or Parts I and III / PMI of the PM)

Point size 9 (minimum): • Inner and outer labels, • Tables in Part III of the PM.

Minimum Point size 6: • Special containers (i.e., small inner labels ;

e.g. blister strip, ampoules, vials, sachets, etc.).

• No smaller than 1.5 mm for ampoules/containers 2 mL or less (1999 CSA standard).

Implementation of PLL in TPD: Application of the GLPPG for Prescription Drugs during the Review of Mock-Up Labels (…continued)

Design and Layout: White Space

• Information is not crowded • Headings and key information are emphasized by white space

around them • Unrelated information is framed or is separated by white space • Consider commonalities of key information to satisfy bilingual

requirements.

Design and Layout: Colour and Contrast

• Ensure colour(s) used on the labels does not affect legibility • When appropriately used, helps differentiate, highlight or draw

attention to information such as: • name of the product and its strength • enhance the prominence of warning statements • Strengths, formulations and dosage forms within a product line • warnings

• Contrast between text and background can enhance readability. • Colours (e.g., red and green) affected by colour-blindness are not

used together • Translucent containers have opaque labels or contrasting type ink

on an opaque background. • Consider matching visual style of inner and outer package labels

Effective use of white space, colour, type weight and size, fonts, caps can help distinguish different

information and/or messages displayed on the

package label.

DIN ########

Pr Proprietary Name A Generic Name A

50 mg

10 Tablets Company

Name

30 Tablets DIN ########

Pr Proprietary Name B Generic Name B

100 mg

Company Name

50 mg 100 mg


GLPPG for Prescription Drugs: Application of the GLPPG during the Review of Mock-Up Labels (…continued) Design and Layout: Proximity and Compatibility

• When examining the product labelling, including evaluating the use of white space, information relevant to a common task or mental operation is generally placed close together to facilitate the readability of end-users.

• Name, strength and dosage form while distinct, are closely related elements used to identify and administer a health product and should be placed in close proximity on a label.

• Standard of manufacture, as applicable, is in close proximity to the product’s non-proprietary name.

• Net quantity in the package is separated from, and less prominent than, the product strength and placed away from the location where the assigned DIN will be printed.

• Unrelated information (including graphics) is not placed between the product name (brand, proper or common name), standard of manufacture and strength.

• The brand name, non-proprietary name and standard of manufacture, are continuous text and uninterrupted by extraneous text, , logos, artwork or other marks.

Grouping of Information on a Secondary Panel: [Quantitative declaration of the medicinal ingredient; and non-medicinal ingredient, where applicable] [Dosing Instructions…] [Reconstitution instructions…] Storage instructions for unused vials and reconstituted solutions (where applicable) Keep out of reach and sight of children. Product Monograph available upon request. Pharmacist: Dispense with Patient Medication Information [ Consumer Information Leaflet]. For questions or to report problems, please contact [Questions or concerns]: Company A ADDRESS, A0B 1C2 [email protected]

Company Name

Information relevant to a common task or

mental operation is placed close together

DIN ########

Pr Proprietary Name A Generic Name A

10 mg / 2 mL (5 mg / mL)

For IV use only

2 mL

Company Name


GLPPG for Prescription Drugs: Application of the GLPPG during the Review of Mock-Up Labels (…continued)

Design and Layout: Use of Abbreviations, Symbols, and Dose Designations

• Avoid use of error-prone abbreviations, symbols, and dose designations are used. (ISMP Canada’s “Do Not Use” list.)

• “mcg” rather than “μg” is used for “micrograms”.

• Any abbreviation or symbol is not ambiguous or has been explained.

• Sufficient space is left between text characters and typographical symbols (e.g., around the slash character, “/”) to avoid the misinterpretation of typographical symbols as letters or numbers; and enhances legibility.

• Consider the intent in which the slash character (“/”) is used on the label and ensure it is not confusing in any way

• Proper or common names or ingredients are not abbreviated.

• Uncommon routes of administration are expressed in full (e.g., intradermal, intrathecal).



Design and Layout: Logo, Branding and Trade Dress

• The amount of space required for a logo is minimized to optimize the amount of space available for key elements of product information.

• Logos and trade dress on product labels: • do not distract the user or impede communication of key

information • do not make it difficult to distinguish between different strengths

of the same product • are not misleading or confusing

• Text and images (or logos) are not superimposed.


GLPPG for Prescription Drugs: Application of the GLPPG during the Review of Mock-Up Labels (…continued) Label Information: Expression of Strength:

• There are no trailing zeros after decimal points ("2" not "2.0" or “2.50”)

• There are leading zeros before decimal points (“0.2” not “.2”)

• For parenteral products*, the following information should be displayed:

• quantity of each medicinal ingredient per mL • total quantity per total volume • the total volume/container

• Expressions of strength are not placed near other numeric information, such as the number of units in the package.

• For containers with less than 1 mL total volume, the strength is expressed as the quantity of active ingredient in the volume provided (e.g., 3 mg/0.5 mL).

• To avoid confusion, add a space before and after the slash character (“/”)

• For large numbers, use a thin space, rather than a comma, to separate digits into groups of three (e.g., 10 000)

• For products intended for both adult and pediatric use, the expression of strength is presented in a format that simplifies calculation of pediatric doses.

*Ensure there is consistency

between product strength (including units) and dosing

instructions across all panels of the

labels and with the Product Monograph

(refer to the DOSAGE AND

ADMINISTRATION section of the

proposed Product Monograph).



Label Information: Expiry Date:

• The expiration date is expressed in full or in a manner that end users clearly understand (e.g., year, month, day)

• Descriptors: – EXPIRATION – EXPIRATION DATE – DATE D’EXPIRATION – EXP (acceptable as a bilingual

expression) • One of the formats are used to express

expiry date, in order of preference: – YYYY-MM-DD – YYYY-Month in full-DD – YYYY-MM – YY-MM

• Month: – Where the day is not mentioned, it is

presumed to be the last day of the month.

– Bilingual abbreviations for the month are: JA, FE, MR, AL, MA, JN, JL, AU, SE, OC, NO, DE

Label Information: Lot Number: • Descriptors:

– Lot number – Lot no. – Lot

No label information should be removed or destroyed when the

container is opened.

For legibility purposes, font size requirements also apply to Lot

and expiry date printed or embossed on a label


Label Information: Cautionary / Critical Warning Statements:

• Intended to attract the attention of the users • Often presented framed or boxed as per the Product Monograph and patient

information leaflets • Use of signal word (e.g., WARNING, ALERT, CAUTION, DANGER)

• Where justified, should be displayed on the principal display panel on both the inner and outer labels, and presented: • in clear, simple consumer language • uninterrupted by any text, artwork, or marks • brief and explicit as possible

• Positive statements should be used • For example: “For Intravenous Use Only—Fatal if Given by Any Other Route”). • Some negative statements in warnings are still very effective and will continue to be

used (e.g., Do not take Drug Product B while taking Drug Product A).

• Product-Specific examples included

Parenteral medications: • Concentrates – Inclusion of “Concentrate: Must Be Diluted Before Use” • Use, a relevant warning statement (such as “Dilute Before Use”) on the principal

display panel of both inner and outer labels for products requiring reconstitution • For products that require different dilutions for adult and pediatric administration, a

warning is included on a side panel to indicate the specific dilutions required to produce a ready-to-administer dose for the intended patient population.

Example: Applying the GLPPG and existing Regulatory Requirements:

CAUTION: KEEP OUT OF REACH OF

CHILDREN. This package contains enough drug to seriously harm a child. DO NOT GIVE to children / teenagers less than 18 years of age who have chicken pox or cold/flu symptoms before a doctor is consulted about Reye’s Syndrome, a rare but serious illness reported to be associated with acetylsalicylic acid. Do not use in the last trimester of pregnancy. Consult a doctor before use when pregnant/nursing.

Consider use of contrasting

characteristics (e.g., type size, weight (bold

font), colour and spacing)


Packaging:

• Package and label are designed with consideration of how the product will be used at the point of administration.

• Labels are oriented for optimal readability when the product is administered

• The container facilitates correct selection and use (e.g., a topical medication is not provided in a vial format similar to that used for injectable medications).

• Give user a cue to help identify intended route and method of administration

• Multi-Part Products

• Dose-Delivery Devices

• Small Containers and Small-Volume Containers

• Pediatric Products

• Blister Packaging: General and those designed for sequential use

• Transdermal Patches


GLPPG for Prescription Drugs: Application of the GLPPG during the Review of Mock-Up Labels (…continued) Principles of User Testing:

• Design considerations for labelling and packaging for a health product should begin as early as possible in the development process:

• Additions to a product line (e.g., additional dosage forms, formulations)

• Making changes to existing marketed labels (e.g., new strength, new dosage form, new packaging format, new indication/conditions of use)

• Significant changes to the layout and colour • Prior to a revision to address a known problem or error • Scheduling considerations (prescription and non-prescription

status within the same product line) • Products with critical safety issues (e.g., fatal if given by

another route of administration)



Remember to Incorporate Plain Language Labelling early in the label design • Clear writing style designed to be easy to read and

understood by intended audience

• Active instead of passive voice of instructions

• Positive Instructions

• Bulleted text instead of complete sentences


Implementation of PLL in TPD: Progress Made to Date and Best Practices

• Continue to assess regulatory information • Critical information outlined in the Regulations that must appear on the Principal

(main) panel; as well as those appearing on any panel of a label • Impact of missing information on the design and white space of label

• Adjustment on how to assess overall design and layout • Ensuring clear, legible and understandable package labels • Key Elements on the principal Display Panel recommended by GLPPG • Increased Training in TPD

• Change in Labelling Review Processes to incorporate PLL requirements • Initial-90 day PLL Review and Final 90-day PLL Review Checklists

• Initial Review: • Earlier communication between the review areas and the label reviewers • Typically issue a 30-day clarifax to allow sponsors sufficient time to revise the

design and layout of the mock-up labels where needed

• Final Review: • Content Review • Final versions of the mock up labels are required prior to final decision • Sponsors need time to submit the finalized version

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• A New Labelling Division (LD) in TPD was created as of August 8, 2016


• Increased labelling team meetings prior to the PLL Regulations coming into force and thereafter, to foster consistency and a common TPD approach on the adoption of the GLPPG recommendations within the context of the existing Labelling Guidance and regulatory requirements

• PLL Task Team Created to address PLL Implementation concerns

• Exploring opportunities to enhance existing review tools that facilitate PLL review

• Earlier engagement with other Review Divisions (i.e., Clinical, Quality, Biopharmaceutics) to confirm the scientific content impacting other PLL materials.

– During the review of an in-house submission – Prior to issuance of an Advisement or Class Labelling PM update that impacts Part III of the PM

• Increased engagement and sharing of best practices with BGTD, MHPD and NNHPD

• Enhancing Transparency and Communication with Sponsors on how submissions are reviewed under PLL Regulations

– Sharing initial and Final 90-day checklist with sponsors as part of the 2016 DIN Annual Notification Mail out

– Seeking feedback on the sponsor’s perspectives on PLL implementation – Revisions to the Guidance Document: Questions and Answers: Plain Language Labelling

Regulations

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References Canada Gazette Part II: Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) http://www.canadagazette.gc.ca/rp-pr/p2/2014/2014-07-02/html/sor-dors158-eng.php Guidance Document; Questions and Answers: Plain Language Labeling Regulations http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/pll_qa_fin_qr_elc-eng.php#a6 February 2, 2016 Notice: Updates to the Guidance Document Question and Answers: Plain Language Labelling Regulations http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/pll-qa-notice-avis-qr-elc-eng.php Guidance Document for Industry – Review of Drug Brand Names http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2014-review-examen_drug-medicament_names-marques/index-eng.php FAQ Review of Drug Brand Names – http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2014-review-examen_drug-medicament_names-marques/faq-eng.php Good Label and Package Practices Guide for Prescription Drugs http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2016-label-package-practices-pratiques-etiquetage-emballage-rx/index-eng.php Good Label and Package Practices Guide for Non-prescription drugs and Natural Health Products http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2016-label-package-practices-pratiques-etiquetage-emballage-non/index-eng.php

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http://www.canadagazette.gc.ca/rp-pr/p2/2014/2014-07-02/html/sor-dors158-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/pll_qa_fin_qr_elc-eng.php#a6

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/pll_qa_fin_qr_elc-eng.php#a6

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/pll-qa-notice-avis-qr-elc-eng.php

http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2014-review-examen_drug-medicament_names-marques/index-eng.php

http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2014-review-examen_drug-medicament_names-marques/index-eng.php

http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2014-review-examen_drug-medicament_names-marques/faq-eng.php















http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2016-label-package-practices-pratiques-etiquetage-emballage-rx/index-eng.php





















http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2016-label-package-practices-pratiques-etiquetage-emballage-non/index-eng.php





















Veronica Yip Labelling Manager

Bureau of Gasteroenterology, Infection and Viral Diseases Therapeutic Products Directorate

Health Canada Email: veronica,[email protected]

Telephone: (613) 946-7209 / Fax FAX: (613) 941-0571

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