Frequently Asked Questions: Product Monographs Posted to the Health Canada Website
Contact: Policy Bureau Enquiries
This Frequently Asked Questions document provides a broad range of information about the Health Canada-authorized Product Monographs and how they may be accessed from the Health Canada website. In addition, the document helps to identify and explain differences between these Product Monographs and drug information available from some other sources.
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.
The Product Monograph consists of three sections:
- Part 1 - Health Professional Information, that is (i.e.) prescribing information;
- Part 2 - Scientific Information; and
- Part 3 - Consumer Information.
Manufacturers (or drug sponsors) are required to develop a detailed Product Monograph in accordance with the Guidance Document: Product Monograph. Health Canada reviews this Product Monograph as part of the drug review process. When deciding on the wording, there is careful consideration 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 health care professionals about the appropriate use of the drug.
2.2 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.
2.3 Why is Health Canada making Product Monographs available?
Health Canada's commitment to make Product Monographs available is in line 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. Since May 29, 2006, Product Monographs were being released directly to requesters who contacted the Department (see Notice: "Transparency: Release of Product Monographs Directly to Requesters"). Prior to this Notice, the documents were released only through the Access to Information Act process, which took considerable time and resources.
Health Canada believes that health care professionals, drug manufacturers, patients and consumers 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 authorized Product Monographs, Canadians can rely on free, unbiased, accurate information concerning 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 (e.g.) family doctor or pharmacist].
2.4 When I search for Product Monographs, why are some available in English and French and others only available in English?
Drug manufacturers (sponsors) are only required to file the Product Monograph in one official language, of their choosing. The document is reviewed in the language submitted as part of the drug review process. Once the drug and/or changes to the drug are approved for marketing in Canada, drug sponsors translate the document to support sales and marketing efforts and web-posting on their individual websites. Sponsors are required to ensure that any translations accurately represent the original Health Canada-authorized version. However, there is no regulatory requirement for sponsors to provide the Department with a copy of the second language version. Therefore, the majority of Product Monographs in the Departmental database are currently in one official language, i.e., English.
Health Canada recognizes the importance of making the Product Monograph available in both official languages. New procedures are being put in place so that the second language version will be acquired from the sponsor. This will ensure that new documents are posted in both languages. For product monographs authorized since 2004, Health Canada is making every effort, through discussions with drug sponsors, to obtain as many French language versions as possible. Through these two actions, the database will have an increasing number of documents in both official languages.
2.5 Where can I find Health Canada-authorized Product Monographs?
Product Monographs may be accessed from Health Canada's Drug Product Database Online Query.
2.6 Do Product Monographs have similar information as that provided by my pharmacist?
In general, information provided at pharmacies across Canada will contain information similar to the Part 3 - Consumer Information section of the Product Monograph. The full Product Monograph authorized by Health Canada also contains technical information directed to healthcare professionals, namely Part 1 - Health Professional Information, i.e., prescribing information, and Part 2 - Scientific Information. It should also be noted that Health Canada does not review the information sheets issued by pharmacies. The provision of these information sheets would be considered to be part of the practice of pharmacy, which is the responsibility of provincial authorities.
There have been instances where drug information sheets or pamphlets provided by Canadian pharmacies have not 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.
2.7 I am looking for a Product Monograph and cannot find it. Why?
There are instances where a product monograph may not be available on the Department website; for example, those product monographs authorized prior to January 2004.
At the time of launch, approximately 1,500 Product Monographs authorized since January 2004 will be available. This number will increase with time as new products receive market authorization or as changes to existing drugs are authorized and their updated Product Monographs are reviewed by Health Canada.
See Question 2.8, for information on obtaining Product Monographs outside the scope of the web-posting initiative.
2.8 I am looking for a Product Monograph that is not available from the website? Is it still possible to get a copy of it?
A Product Monograph that is not available on the Health Canada website may still be obtained through a direct request to the Department. The version released will reflect the latest Health Canada-authorized document and may not be identical to the version maintained by the product sponsor. For information on the direct release process, consult the May 29, 2006 Notice: "Transparency - Release of Product Monographs Directly to Requesters."
2.9 I did a search 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. Differences may exist, for example, in formulation, dosage forms, indications and in the timing of the filing and approval of individual Product Monographs.
2.10 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 will reflect all approved formulations, indications and strengths, irrespective of a manufacturer's decision to market all or some.
2.11 Can you explain the meaning of the "submission control number" that is on the front page of the Product Monograph?
The submission control number is assigned to every submission when it arrives in Health Canada. This number allows for the effective management of that submission and all of the data and correspondence related to it.
The submission control number should not be confused with the unique Drug Identification Number (DIN) which must be displayed on a drug's label.
2.12 Where can I get more information about Product Monographs?
Questions regarding the posting of Product Monographs should be directed to:
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
Other questions regarding the contents of the Drug Product Database should be directed to:
3.0 Sponsor Information
3.1 Has Health Canada developed a process for requesting the French Product Monograph? What will be the timing for these requests?
Yes. Following authorization of a drug submission or notifiable change, Health Canada will request the French language version of the Health Canada-authorized Product Monograph to be submitted in PDF format, along with an attestation on the accuracy of the second language translation:
- within 20 days of approval by Health Canada (Notice of Compliance 'NOC' or No Objection Letter 'NOL'),
- at least 10 days prior to market notification by the sponsor
The time lines are required in order to ensure timely availability of Product Monographs for those products already marketed (i.e. in the case of products where market notification is not required) and to provide Health Canada sufficient time to make any necessary pre-posting adjustments and to add the document to the Drug Product Database.
3.2 Will Health Canada require a specific file format for the Product Monographs posted to the Website?
Yes. Health Canada is requesting that Product Monographs be provided in PDF format for web-posting purposes.
3.3 What if I have a change to an authorized Product Monograph that does not require market notification (i.e., DIN notification) and the change will not be implemented until a future date? Will Health Canada post this latest version of the Product Monograph or can the posting be delayed until the changed drug is marketed?
Generally, Health Canada would post the most recent Product Monograph of a marketed drug once it is authorized. However, specific cases should be discussed with the appropriate Review Bureau at Health Canada.
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