Product monographs: Frequently asked questions

Effective date: 2020/11/01

1.0 Purpose
2.0 General information
3.0 Updating the product monograph
4.0 XML product monograph

1.0 Purpose

This Frequently Asked Questions (FAQ) document is intended to create a centralized location for Canadians and drug sponsors to find information about Health Canada-authorized Product Monographs.

This document provides a broad range of information about Product Monographs, including general information, revisions to Product Monograph guidance and templates, Product Monographs in the Extensible Markup Language (XML) format, and controlled vocabularies. In addition, this document helps to identity and explain Health Canada's expectations for sponsors to follow the latest guidance and templates when preparing or revising Product Monographs.

2.0 General information

2.1 What is a product monograph?

A Product Monograph is a factual, scientific document on a drug product that, devoid of promotional material, describes the properties, claims, indications and conditions of use of the drug and contains any other information that may be required for optimal, safe and effective use of the drug.

A Product Monograph should include appropriate information respecting the name of the drug, its therapeutic or pharmacologic classification, its actions and/or clinical pharmacology, and its indications. The Product Monograph should also include: contraindications, dosage and administration, symptoms and treatment of overdosage, dosage forms, warnings, precautions, adverse reactions, drug interactions, effects on laboratory tests, storage and stability, special handling instructions, pharmaceutical information, information on clinical trials, microbiology, toxicology, and information for the patient. In addition, the Product Monograph should state both the dates of initial approval and, when applicable, the date of last revision.

The Product Monograph consists of three sections:

Part I - Health Professional Information;
Part II - Scientific Information; and
Patient Medication Information (PMI) (previously called Part III - Consumer Information)

Drug manufacturers (or sponsors) are required to develop a detailed Product Monograph in accordance with the Guidance Document: Product Monograph. Health Canada reviews the Product Monograph as part of the drug review process. When deciding on the wording, careful consideration is given to the content, language and format used. Once authorized by Health Canada, the Product Monograph is used by the drug manufacturer or sponsor to inform physicians, pharmacists, dentists, nurses and other healthcare professionals about the appropriate use of the drug.

2.2 I keep seeing different years associated with the product monograph guidance and templates. What do they mean?

The year refers to the latest version of the Product Monograph guidance and Product Monograph template. As per the Notice: Product Monograph Implementation Plans, Health Canada is now taking steps towards full adoption of the 2016 updates to the Guidance Document: Product Monograph.

The first Canadian Product Monograph guidelines were published in 1976 and revised in 1989. The Product Monograph has gone through a series of modifications since, but the most substantial ones were in 2004, 2014, and 2016. The latest version of the Product Monograph template and guidance is 2020.

2004 product monograph

In 2004, the Guidance for Industry: Product Monograph came into force, to replace previous guidelines. This guidance also included 5 specific templates: a standard template, a template for products that have been granted a notice of compliance with conditions (NOCc); a template for subsequent entry (bioequivalent) products; one for Schedule C products; and one for Schedule D products. Additionally, a new section of the Product Monograph was introduced to provide information for the consumer, the Part III: Consumer Information section.

2014 product monograph

In 2014, Part III: Consumer Information section was replaced with the Patient Medication Information section (PMI). The new PMI section featured a clear writing style designed to be easy to read and understand by the intended audience (i.e., plain language), with a targeted reading level between Grades 6 and 8. Plain language includes how information is set out on the page, using white space, fonts that are easy to read, and the ‘active’ instead of ‘passive’ voice for instructions. The new format was implemented in a phased approach and limited to New Drug Submissions.

2016 product monograph

In 2016, Part I: Health Professional Information and Part II: Scientific Information of the Product Monograph were revised with plain language enhancements, including reorganization of information, to make health professional information easier to read and critical safety information easier to find in the Canadian Product Monograph. As per the Notice - Final Release: Part I - Health Professional Information and Part II - Scientific Information of the Guidance Document - Product Monograph, implementation was mandatory for New Drug Submissions (NDSs), Abbreviated New Drug Submissions (ANDSs) and Supplements to Abbreviated New Drug Submissions (SANDSs) where the corresponding innovator Product Monograph was in the 2016 format. A new Product Monograph template, Schedule D - Biosimilar Biologic Drug, was released in 2017 to guide sponsors in the preparation of biosimilar Product Monographs.

Where we are now: 2020 product monograph

In 2020, all 6 Product Monograph templates were amalgamated into one Master Product Monograph Template. The 2020 amendments to the Guidance Document: Product Monograph complement the Master Template to allow both documents to be easily read in conjunction. In addition, administrative changes have been made to accommodate Product Monographs prepared in the Extensible Markup Language (XML) format, introduced for the first time in 2020. Some instructions have been added or clarified to aid sponsors in preparing and updating Product Monographs. This update addresses the full implementation of all plain language format and content changes made in 2014 and 2016.

2.3 What is the “control number” that is on the front page of the product monograph?

The control number is assigned to every submission when it arrives in Health Canada. This number allows for the effective management of the submission, including related data and correspondence.

The control number should not be confused with the unique Drug Identification Number (DIN) which must be displayed on a drug's package label(s).

2.4 Do all drugs have a product monograph?

No. Although most prescription drugs and some non-prescription drugs will have a Product Monograph available, drugs with lengthy market histories and an established safety profile will generally not have an associated Product Monograph. In such circumstances other information, such as package labels and inserts, prescribing information, or other drug information are produced and these must be consistent with authorized conditions of use.

2.5 Where can I find Health Canada-authorized product monographs?

At this time, Product Monographs authorized by Health Canada may be accessed from Health Canada's Drug Product Database Online Query.

2.6 Why is Health Canada publishing product monographs?

Health Canada's commitment to make Product Monographs available in both official languages is in line with the Official Language Act and with the Department's goals for increased openness and transparency. It also responds to demands from stakeholders, including the public, for greater access to Health Canada-authorized drug product information.

Furthermore, by publishing the Product Monographs on its website, Health Canada makes access to these documents simpler and easier.

Health Canada believes that healthcare professionals, patients, consumers and drug manufacturers, should have access to authorized Canadian information in order to support the safe and effective use of medications. Patients and consumers may obtain information about their medications from a variety of sources, including the internet, television advertisements from the United States and from pharmacies. Some of these sources may not provide information that is consistent with Health Canada-authorized information. By providing a central location for Health Canada authorized Product Monographs, Canadians can rely on free, unbiased, accurate information regarding the drugs they are taking.

Health Canada strongly encourages patients and consumers to discuss treatment options and questions relating to drug information with their healthcare provider (for example, family doctor or pharmacist).

2.7 Is the Health Canada-authorized product monograph identical to those posted by the drug manufacturers on their websites?

Not always. In some instances, drug sponsors may remove information from their Product Monographs to reflect only those strengths and formulations that they have chosen to place on the Canadian market. In contrast, a Health Canada-authorized version should reflect all Canadian authorized formulations, and strengths, irrespective of a manufacturer's decision to market all or some.

2.8 Do product monographs have similar information as that provided by my pharmacist?

The one page summary that is printed and provided to Canadian patients at pharmacies across Canada may contain different information than that in the Health Canada authorized Product Monograph. This is because, in general, the summary provided by pharmacies is mostly derived from United States drug information sources, and is not reviewed by Health Canada. The provision of these information sheets would be considered to be part of the practice of pharmacy, which is the responsibility of provincial authorities.

The full Product Monograph authorized by Health Canada contains all of the technical information directed to healthcare professionals, namely Part I - Health Professional Information, and Part II - Scientific Information.

As such, the drug information sheets or pamphlets provided by Canadian pharmacies have not always been consistent with information in the Health Canada-authorized Product Monograph. By making such documents available in a central location, both pharmacists and patients/consumers will have access to the Health Canada-authorized information when discrepancies arise.

2.9 When I search for product monographs using the drug product database, why are some available in English and French and others only available in English?

As of June 13, 2015 and June 13, 2017, drug manufacturers (sponsors) are required to file the Product Monograph in both official languages for prescription and non-prescription drugs, respectively. The Product Monograph is reviewed in the first official language as part of the drug review process. Drug sponsors are required to submit the first language Product Monograph prior to authorization and submit the second language Product Monograph no later than 20 days following Notice of Compliance (NOC) issuance. Sponsors are required to ensure that the translations they provide accurately represent the original Health Canada-authorized version. Health Canada then posts the second language Product Monograph to accompany the first language Product Monograph. If the Product Monograph is not posted in the second language, it means that the drug sponsor has not yet submitted the finalized second language Product Monograph following authorization, or the Product Monograph has not been updated since June 2015 for prescription drugs, and June 2017 for non-prescription drugs.

2.10 Why can’t I find the product monograph I am looking for on the drug product database?

There are instances where drugs may not have an associated Product Monograph (see Question 2.4) or the Product Monograph may not be available on the Health Canada website; for example, Prescribing Information for products authorized prior to January 2004 that have not since filed subsequent changes.

2.11 I searched the drug product database by “active ingredient” and found several drug products. Could there be differences between the product monographs for these products?

Yes. There may be different drugs that contain the same active ingredient. There may also be drugs that have a brand name (innovator) and generic versions or biosimilars. Differences may exist, for example, in formulation, dosage forms or strengths, indications and in the timing of the filing and authorization of individual Product Monographs.

2.12 Why are changes to the patient medication information important?

In 2014, the formerly titled “Part III: Consumer Information”, now titled “Patient Medication Information”, was revised to include plain language elements, including new language and formatting. The goal of these changes was to make drug product information clear, concise and easier to understand for Canadians. When information about drug products is unclear or confusing, there are often negative health impacts such as medication errors. Improved labelling is an important step in decreasing the number of negative health events caused by improper use of drug products.

2.13 How do I know if my wording is considered plain language? Are there any tools or references on plain language writing?

The target reading level is Grades 6 to 8. There are tests and resources available online and in libraries which evaluate text information. The Flesch-Kincaid, Fry Graph Readability Formula and SMOG (Simple Measure of Gobbledygook) are a few health literacy tools which sponsors can use to test their revised information. Some readability features are also offered in newer versions of Microsoft Word © (e.g., Flesch-Kincaid grade level).

The Canadian Public Health Association website is a good source of information on health literacy, including plain language writing, and includes links to reference documents such as Good Medicine for Seniors: Guidelines for Plain Language and Good Design in Prescription Medication.

2.14 What is the connection between the plain language revisions to the product monograph and work on the broader plain language labelling initiative?

Plain language revisions to the Product Monograph, are an example of the work that Health Canada is undertaking to improve Canadians' understanding of health information and to decrease medication errors. Regulatory changes have also been made which aim to improve the safe use of drugs by making drug labels and packaging easier to read and understand, and complement the proposed changes to the Product Monograph. For more information on the Plain Language Initiative, visit Health Canada's Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs.

2.15 What is Health Canada’s long term vision for the Canadian product monograph?

Health Canada is making it a priority to improve the quality and accessibility of drug product information available to Canadians so they can make informed decisions about their medications and healthcare professionals can access critical drug information quickly and easily.

The Product Monograph is a key component of this strategy as it provides Canadians with Health Canada-authorized factual and scientific information about how to use their drugs safely and effectively.

The Product Monograph Implementation Plan will enable a digital first strategy that introduces consistent and reliable labelling by utilizing a single template, a structured format, controlled vocabularies, and alignment with international standards.

The Implementation Plan creates a new platform based on modern technology. This puts Health Canada in a better position to provide progressively more advanced services to Canadians. For more information, please see Question 4.3.

2.16 Where can I get more information about the product monograph?

Questions regarding the guidance document should be directed to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
1600 Scott Street Holland Cross, Tower B
2nd Floor, Address Locater 3102C1
Ottawa, Ontario
K1Y 4N7

E-mail: hc.policy.bureau.enquiries.sc@canada.ca

Questions regarding submissions should be directed to the Office of Submissions and Intellectual Property via email at hc.osip-bppi.sc@canada.ca

Other questions regarding the contents of the Drug Product Database should be directed to:

Email: hc.DIN.sc.@canada.ca

3.0 Updating the product monograph

3.1 What are the changes exactly in the 2020 update to the product monograph guidance and template?

The 2020 amendments to the Guidance Document: Product Monograph include formatting and editorial updates and the creation of a Master Template. No significant content changes were made.

Updates include:

Consolidation of the six Product Monograph templates into one “master” Product Monograph template.

Figure 1: Consolidation of six templates into one “master” template

Text description

The six individual Product Monograph templates: Product Monograph Template - Standard, Product Monograph Template - Notice of Compliance with Conditions, Product Monograph Template - Subsequent Entry Product, Product Monograph Template - Schedule C, Product Monograph Template - Schedule D, and Product Monograph Template - Schedule D - Biosimilar Biologic Drug, were combined into one consolidated template, the “Master” Product Monograph Template.

Consolidation of information from the appendices into the guidance body, and aligning section numbering with the new “master” Product Monograph template to improve clarity of instructions and facilitate ease of use.
Formatting to accommodate Product Monographs prepared in the Extensible Markup Language (XML) format. For example, changing the order of the following two sections so Patient Medication Information appears before Read this for Safe and Effective Use of your Medicine.
Addition of instructions regarding omission of sections. For example, major sections headings must be consistent across all Product Monographs and cannot be deleted, with the exception of Serious Warnings and Precautions Box and Supporting Product Monographs. However, subsections and their headings not applicable to a specific product can be omitted. The numbering for all sections and subsection headings must remain the same even when a subsection is omitted.
Enhancement of instructions to clarify what kind of information should be included under certain sections of the Product Monograph or how information should be presented.
Clarification of instructions on the Recent Major Label Changes section.

3.2 What if I am in the queue on the implementation date?

Products that are under review prior to November 1, 2020 are not required to adhere to the implementation deadline as specified in the Notice: Product Monograph Implementation Plans. Any subsequent submissions with proposed changes to the Product Monograph filed on or after November 1, 2020 will be expected to follow the 2020 updates to the Product Monograph Guidance and utilize the Master Template.

3.3 What if my product monograph is not in the 2020 format?

As of November 1, 2020, sponsors are expected to update Product Monographs under the 2020 guidance and format if they are filed to Health Canada as part of a submission. However, if no changes other than re-formatting are proposed, proactive updates are encouraged and should be submitted as a Labelling Only Supplement to a New Drug Submission or to an Abbreviated New Drug Submission.

3.4 I am required to file submissions under the 2016 product monograph guidance and format beginning November 1, 2020. However, the guidance has been updated to the 2020 version. Which version should I use?

Health Canada released the 2020 updates to the Guidance Document: Product Monograph and the Master Product Monograph Template to consolidate previously separate templates, add and clarify instructions, and accommodate Product Monographs prepared in the Extensible Markup Language (XML) format. If a sponsor has already filed a Product Monograph using a 2016 template, they may be requested to reformat to the 2020 format during review. It is recommended to use the latest guidance and Master Template to prepare any new Product Monographs or file changes to existing Product Monographs that are scheduled accordingly with the product lifecycle on or after November 1, 2020.

3.5 I cannot reformat the product monograph because I don’t have information to include in some sections of the product monograph. What do I do?

In some cases, sponsors may not have information to populate some sections in the Product Monograph. However, it does not mean that it is acceptable to keep the Product Monograph in an old format or to omit major sections. Instead, the sponsor is to provide a rationale to Health Canada as to why information has been omitted or is missing and, if found acceptable, a disclaimer is to be added to address the missing information in the appropriate section of the Product Monograph. For example, if clinical trial data is not available, text under the CLINICAL TRIALS section heading may state, “the clinical trial data on which the original indication was authorized is not available”.

3.6 Should I provide an annotated ‘old’ format product monograph, noting what sections were moved, what text was added, etc., to align with the 2020 format?

Yes, it will facilitate review if it is made clear where the text came from or where it went during the reformat to the 2020 template.

3.7 Are administrative submissions or submissions that include an administrative component within the scope of the product monograph implementation plan?

The Department strives to have all authorized Product Monographs in the same format, beginning November 1, 2020 (i.e., under the guidelines of the Guidance Document: Product Monograph and Master Template). This will serve to reduce the confusion that different templates can create for the healthcare professional and consumer/patient and make retrieval of critical safety information quicker. With this goal, Health Canada encourages sponsors who are filing submissions that include an administrative component to do so in accordance with the 2020 updates to the Guidance Document: Product Monograph and Master Template. There will be situations where this is not practical, in which case sponsors should discuss these in advance with Health Canada in order to determine the best submission pathway.

As an example, reformatting a Product Monograph requires a review of its content to ensure the information is presented properly in the new template. This assessment may not be practical for submissions subject to a 45-day screening performance standard. As such, for administrative submissions, the proposed Product Monograph should only adopt the latest Guidance Document: Product Monograph and Master Template when this format has been reviewed and approved for their referenced product. The exemption from filing under the latest Guidance Document: Product Monograph and Master Template ensures timely access to drugs associated with bulk filings for product ownership transfers, and to avoid importation delays or refusals at the border.

3.8 Is it acceptable to transfer text to the new 2020 format without reformatting?

No, all new requirements outlined in the 2020 update to the Guidance Document: Product Monograph should be adhered to during all format conversions.

3.9 What is the filing category and the associated fees for a submission solely for the transition of a product monograph to the 2020 template?

The appropriate filing category for a Product Monograph format change to the new 2020 template is the “Labelling only” fee class, as long as no other changes requiring supporting data are proposed. This means that if new data is being submitted to populate sections of the 2020 Product Monograph format, then the sub-class as a Labelling Only will no longer be applicable.

4.0 XML product monograph

4.1 What is the structured product monograph?

Health Level 7 International's Structured Product Labelling (SPL) is a data standard which defines the content of human prescription drug labelling in an Extensible Markup Language (XML) format. In the Canadian context, the Product Monograph is the 'label' or 'the document' that is being structured.

In this context, structure refers to the fact that the Product Monographs content has been encoded within XML. As a result, the narrative text (e.g., section headings, all text and tables) and product information (e.g., manufacturer, ingredients, dosage forms and packaging) are structured allowing the ability for indexing and searching.

4.2 What is XML?

XML is a text-based markup language used to encode electronic documents in a structured format that is both human and machine-readable. XML is used as a common format to facilitate the interchange of data over the internet.

XML is a free open specification maintained by the World Wide Web Consortium (W3C).

4.3 Why is Health Canada transitioning to the XML structure?

As per the Notice of Intent: Transitioning Product Monographs to a Structured Format, the XML Product Monograph will allow Health Canada and stakeholders to deliver benefits not previously possible. For example,

Search: Structured information increases the level of detail that is available to the public. It will be easier to index and search for drug product information; particularly drug product ingredients.
Innovation: Stakeholders will have access to structured drug product and prescribing information. This can facilitate use for different purposes such as electronic prescribing, electronic health records, automation, multi-channel publishing and mobile applications.
Consistency: Controlled vocabularies will introduce a consistent use of scientific terminology and definitions across all drug products and Product Monographs.

4.4 Can I file a XML product monograph by itself via the common electronic submission gateway?

No, the XML Product Monograph must always be filed as part of a submission.

4.5 Are there sites for publishing XML product monographs, where the general public is able to access information about medications? How do you list these files onto the public domain?

At this time, approved Product Monographs in PDF format are made available via the Drug Product Database (DPD) Online. The Health Canada website will be updated to make XML Product Monographs available to the public. More information will be posted when available.

4.6 Can I switch the format of the product monograph to XML during review? What about previously authorized product monographs?

At this time, it is not possible to switch formats during review. Products that have already received authorization (i.e., Notice of Compliance) are not required to submit an XML Product Monograph. However, you may voluntarily convert to the XML format.

4.7 Is it mandatory to submit the XML product monograph in both the languages or would submitting only in one language be sufficient?

Sponsors are required to provide Product Monographs in both official languages. For more information on what should be submitted and when, please refer to the Guidance Document Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs.

4.8 Will Health Canada require a specific file format for XML product monographs to be posted to the website?

No. Product Monographs will be posted in the format associated with their filing. However, Health Canada's intent is to transition towards Product Monographs being available online in XML format. More information will be provided as it becomes available.

4.9 Are there validation-related information tools or validators to validate XML product monograph files? Is validation fully implemented with Health Canada for XML product monographs?

Yes, Health Canada does have the internal capability to validate XML Product Monographs. Similar to eCTD sequences, Health Canada will validate XML Product Monographs upon receipt and provide sponsors with a validation report if there are any issues. Health Canada does not recommend or endorse any particular solution.

4.10 We added sponsor defined subheadings by modifying the title of the “Unassigned” heading. How should we display these headings in the Word format of the product monograph?

“Unassigned” sub-sections in the Microsoft Word© Product Monograph should be displayed as shown in the XML Product Monograph style sheet (i.e., bold text, left aligned, on a line by itself).

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Date modified:: 2020-10-29