Health Canada Product Monograph. What Is Included and How Can Companies Effectively Manage Their Product Monographs?

Learn about this key resource for healthcare professionals and patients in Canada, providing important information about prescription drugs approved for sale in the country

What is a Health Canada Product Monograph?

A Health Canada Product Monograph (PM) is a document that provides information about a prescription drug product that has been approved for sale in Canada. The PM includes details about the product’s indications, dosage, administration, precautions, and potential adverse reactions.

The product monograph is intended to provide healthcare professionals with the information they need to prescribe and use the product safely and effectively. It is also intended to provide patients with information about the product and how to use it.

The PM is developed by the pharmaceutical company that manufactures the product and is reviewed and approved by Health Canada, the federal regulatory authority responsible for the safety and effectiveness of drugs in Canada. The PM is a public document that is available on the Health Canada website.

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What is not included in the Health Canada product monograph?

While the PM is a comprehensive document that provides detailed information about a prescription drug product that has been approved for sale in Canada. However, there are some types of information that are not included in the PM. Some examples of information that may not be included in the product monograph include information about:

  1. Off-label use of the product: The PM provides information about the indications for which the product has been specifically approved by Health Canada. If the product is used for other indications that have not been approved by Health Canada, this information may not be included in the PM.
  2. The product’s patent status: The PM does not typically include information about the patent status of the product. This information can be found in other sources, such as the Canadian Intellectual Property Office website.
  3. The product’s pricing or reimbursement: The PM does not typically include information about the price of the product or whether it is covered by insurance. This information can vary depending on the individual patient and the healthcare system in which the product is being used.

Overall, it is a comprehensive document that provides important information about a prescription drug product, but it does not include all types of information that may be relevant to healthcare professionals or patients.

Where can I specifically find the Health Canada
Product Monograph?

Health canada product monograph

The Health Canada Product Monograph (PM) for a prescription drug product can be found on the Health Canada website. To access the PM for a specific product, follow these steps:

  1. Go to the Health Canada website.
  2. Scroll down to the “Quick links” section and click on “Drugs and health products.”
  3. Click on “Drug Product Database (DPD).”
  4. On the next page, enter the name of the product in the “Search” field and click “Search.”
  5. Click on the name of the product in the search results to access the PM.

Alternatively, you can also access the PM by searching for the product name on the Health Canada website and clicking on the link to the PM in the search results.

The PM is a public document and is available for anyone to view. It is intended to provide healthcare professionals and patients with important information about the product, including its indications, dosage, administration, precautions, and potential adverse reactions.

How do companies manage their Health Canada
product monograph?

Pharmaceutical companies are responsible for managing the product monograph for their products. The PM is a comprehensive document that provides detailed information about a prescription drug product that has been approved for sale in Canada.

To manage the PM, pharmaceutical companies typically have a team of professionals who are responsible for maintaining the accuracy and completeness of the document. This may include reviewing and updating the PM to reflect new information about the product, such as new clinical data or revised dosing recommendations.

In addition to maintaining the PM, pharmaceutical companies also need to ensure that they are following Health Canada’s regulations and guidelines for the promotion of prescription drugs. This includes ensuring that the information provided in the PM and other marketing materials is accurate, balanced, and not misleading.

Overall, managing the Product Monograph is an important responsibility for pharmaceutical companies, as it helps to ensure that healthcare professionals and patients have access to accurate and up-to-date information about the products they are prescribing or using.

What is the Circulo Pharma Systems approach to managing
product monographs?

Circulo Pharma empowers the sales organization of drug manufacturers by developing and providing tools to enhance the management, distribution, and production of marketing documentation, Product monographs, and drug samples in compliance with all pharmaceutical regulations. The platform provides:

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