Patient Medication Information Health Canada

[Percival Blanco]

Guidancedocuments are meant to provide assistance to industry and healthcare professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent, and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy, or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

The purpose of this guidance document is to assist sponsors in developing product monographs with acceptable format and content. Health Canada reviews the product monograph as part of the drug review process, as it forms an integral part of a new drug submission. A product monograph is intended to provide the necessary information for the safe and effective use of a new drug and also to serve as a standard against which all promotion and advertising of the drug can be compared.

This guidance document supersedes the Guidance Document: Product Monograph (2014) and the Guidance Document: Product Monograph (2016) for all drug product submissions identified under section 1.2 Scope and application.

A draft copy of the proposed or revised product monograph should be included in the master volume when a New Drug Submission (NDS), Supplement to a New Drug Submission (SNDS), Abbreviated New Drug Submission (ANDS) or Supplement to an Abbreviated New Drug Submission (SANDS) is filed for either a prescription or nonprescription drug. Health Canada will advise the sponsor if the submission is judged to be incomplete in complying with the requirements of Section C.08.002 or C.08.003 of the Food and Drug Regulations.

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 for the drug, and that 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.

From a medical and scientific standpoint, the prime objective of a product monograph is to provide essential information for healthcare professionals, patients and consumers that may be required for the safe and effective use of a drug.

The information provided should be as meaningful and helpful as possible. However, only those indications that are based on substantial evidence of efficacy and safety and that are the subject of an NDS, or an ANDS, or a Supplement to either submission that has received a Notice of Compliance (NOC) pursuant to Section C.08.004 of the Food and Drug Regulations, should be included in the product monograph. The product monograph is not intended to serve as a repository of all information currently available on a drug.

The product monograph, as a document, will be included by Health Canada as part of the NOC respecting an NDS or, when appropriate, an SNDS, an ANDS or a Supplement to an ANDS.

The product monograph serves as a standard against which all promotional material, or advertising distributed or endorsed by the sponsor about the drug can be compared. The product monograph serves the following purposes:

The information described in the Patient Medication Information section of the product monograph contains information for the patient or consumer. This section identifies the information that is to be provided to the patient or consumer either at the time of dispensing as a separate document, or as a package leaflet.

A product monograph can be revised by filing an acceptable SNDS or SANDS. Revisions should be initiated by the sponsor any time updating of the product monograph is required to incorporate additions or other changes related to safety (particularly with respect to warnings, precautions, adverse reactions, and mode of administration) that may be necessary as a result of newly available information. In some instances, it may be necessary to inform the healthcare professional or the patient about special hazards or to issue special warnings before there is an opportunity to revise the product monograph.

The product monograph should also be revised whenever substantial information is available to support new indications or when other changes or deletions in 1 INDICATIONS are required as a result of additional available information.

Revisions to the product monograph must be in compliance with the Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document, the Post-Notice of Compliance (NOC) Changes - Quality Guidance, and the Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs document.

Pursuant to paragraph C.08.006(f) of the Food and Drug Regulations, Health Canada may request that the sponsor revise the product monograph if, on the basis of new information, it is considered to be false, misleading, or incomplete in any respect. Whenever periodic reports on a drug are requested pursuant to paragraph C.08.008(a) of the Food and Drug Regulations, the sponsor should determine whether significant changes should be made in the product monograph as a result of the additional information available.

A copy of the most recently updated product monograph (including the Patient Medication Information) should be provided by the sponsor to healthcare professionals whenever they request prescribing information or other information relevant to the clinical use of the drug. For products that have received an NOC and are marketed, the product monograph must be available in both official languages.

The Health Professional Information portion of the product monograph may also be made available as a package insert. This portion should therefore be provided in connection with the promotion or advertisement of the drug or included in reference manuals distributed or endorsed by the sponsor. In addition the Patient Medication Information may also be provided as part of the package insert for a drug product.

A copy of the most recently updated product monograph (including the Patient Medication Information) should be provided to healthcare professionals prior to, or coincident with, the first direct promotion or marketing of a new drug, and to any healthcare professionals to whom the sponsor sells a new drug before it is generally available.

The Regulatory Project Management Division of the Therapeutic Products Directorate (TPD) or the Office of Regulatory Affairs of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) may assist sponsors with questions concerning the filing of a draft product monograph. General inquiries may be directed to hc.rpmd...@canada.ca or hc.brdd...@canada.ca.

Contains more in-depth scientific/research information such as non-clinical toxicology and data from animal studies and human clinical trials. It complements and extends the information contained in Part I.

Contains information derived from Parts I and II that helps the patient understand what the medication is, how to use it and what the potential side effects are. It is also intended to serve as a guide for healthcare professionals to easily identify the information needed for counselling patients. It is presented in a language and format that is appropriate for a patient audience, including the general public. Patient Medication Information is required for all drugs, regardless of the location of use [for example (e.g.), hospital] or method of administration (e.g., by a third party).

The guidance document presents the sections of the product monograph in the order that they should appear. Sections and their headings should not be omitted, with the exception of 3 SERIOUS WARNINGS AND PRECAUTIONS BOX (i.e., only if there is no Serious Warnings and Precautions Box) and 17 SUPPORTING PRODUCT MONOGRAPHS (i.e., only if there are no supporting product monographs). Sections should not be renumbered or modified as they are expected to be consistent across all product monographs. For example, "4 DOSAGE AND ADMINISTRATION" is always section number 4.

Certain subsections not applicable to a specific drug product may be deleted. For example, "4.8 Radiation Dosimetry" may be deleted if the product is not a radiopharmaceutical. The numbering for remaining subsection headings does not change. The following statement should be included before the Table of Contents:

Health Canada recognizes that this guidance document may not address the information requirements for all drugs and individual judgement remains critical in assessing how or whether to present the information. If information is not available for a section, a rationale should be provided by the sponsor. One of the following or similar statements should be included in the applicable section:

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