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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.
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:
Manufacturers (or drug sponsors) are required to develop a detailed Product Monograph in accordance with the Health Canada Guidance to Industry: 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.
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.
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: Direct Release of Product Monographs 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 (e.g. family doctor or pharmacist).
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.
Product Monographs may be accessed from Health Canada's Drug Product Database.
Searches for a drug or drug product may be made by clicking on the DPD Online Query option.
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.
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.
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: Direct Release of Product Monographs to Requesters."
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.
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.
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.
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, A.L. 3102C5
Other questions regarding the contents of the Drug Product Database should be directed to:
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:
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.
Yes. Health Canada is requesting that Product Monographs be provided in PDF format for web-posting purposes.
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.