Information for Canadians about the Plain Language Labelling Initiative

Purpose:

This document provides information for Canadians about what improvements they may expect as a result of the Plain Language Labelling project.  This includes changes to labelling for drugs that are available with a prescription and drugs available without a prescription.  Some of the changes are based on proposed amendments to the Food and Drug Regulations and therefore at this stage in the project, some parts may be modified based on the type and amount of feedback Health Canada receives.

This document highlights the regulatory and process changes that will have the most impact for Canadian consumers and health professionals.  It will also guide you through the thought process behind some of these decisions.

What is this project about?

Health Canada recognizes that labels are critical for communicating information about health products.  The purpose of the Plain Language Labelling Initiative is to make improvements so that health product labels are clear, accurate, easier to understand, and minimize opportunities for confusion with labels, packages or names.  There will be two types of changes: proposed amendments to the existing regulations that govern drug product labelling and those that will occur through modifications to processes at Health Canada.  The regulatory changes will be explained in online guidance documents, so that drug manufacturers understand what they need to do in order to comply with the new rules.  All of these changes will lead to differences in labelling materials.

What changes could Canadians see?

Making consumer information on prescription drugs easier to find

Product Monographs are produced for most prescription drugs and contain important information about a drug for health professionals and consumers.  The monographs have been available on the Drug Product Database on the Health Canada website for several years.  However the consumer information has been difficult to find because it is the end of the document.  In order to facilitate access to the consumer information section, we will make it available as a separate document on our database.  We will also make the product information in the Drug Product Database available sooner.

Making consumer information on prescription drugs easier to understand

We have also used feedback from consultations to revise the format of the information to consumers to make it more useful.  The consumer information is often found inside the box of a drug that has been prescribed for you.  Some nonprescription drugs also contain this information.  We have reorganised the way the information will be presented so that these documents should be easier to read and understand, while still including all the information required to take the drug in a safe and effective way.  These changes will be implemented over time to give manufacturers the opportunity to revise their documents properly and to give Health Canada labelling experts time to look at the new versions.

Improving the prescribing information on prescription drugs

The Health Canada-authorised Product Monograph is used to prepare monographs in the Compendium of Pharmaceuticals and Specialties (CPS), the document health professionals often consult for drug information.  As part of the Plain Language Labelling Initiative, Health Canada is consulting with health professionals directly to find out the extent to which they use the Health Canada approved documents and possible areas for improvement.  Ultimately, this feedback will determine whether or not we should modify the Health Canada documents for health professionals, and how, so that health professionals can easily retrieve the critical information which is of the most use to them.

Making the labels of over the counter drugs easier to understand

We are proposing that the inner and outer labels of drugs available without a prescription will need to have a Fact Table with the most important information about the drug.  This information will be required to be presented in a standardised format for all nonprescription drugs so that Canadians can find what they need to know easily and quickly.  Nonprescription drugs in the United States have been including a Fact Table for several years.

Encouraging reporting of side effects

For nonprescription drugs, the Fact Table will also need to have information on how Canadians can report harms they may experience from taking the drug including the contact information of a person in Canada who will take the report.  This provision will ensure that consumers have a way to report to the manufacturer any medication harms they experience.

Prescription drugs will also need to include contact information although these products are not required to include it in a Fact Table.

When will these changes take place?

The time to implement the regulatory amendments is proposed to be:

• Six months after the posting of the final regulations in Canada Gazette Part II for prescription products.
• Three years after the posting of the final regulations in Canada Gazette Part II for nonprescription products.

Changes to Health Canada processes, such as posting the consumer information section of the Product Monograph will happen sooner, since they do not require regulatory amendment.

How do I get involved?

Comments on the draft guidance should be provided to Health Canada, preferably in electronic format, within 75 days from the date of this notice.  The comments provided during the stakeholder consultation period may be made available upon request.  Health Canada will consider comments made on the regulatory proposal published in  Canada Gazette, Part I in conjunction with comments made on the guidance.

To provide input on this document, please submit comments by September 6th, 2013 to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Facsimile: 613-941-1812

E-mail: Policy_Bureau_Enquiries@hc-sc.gc.ca, Subject: Plain Language Labelling Initiative