Information for Industry on the proposed regulatory amendment for a Fact Table

Purpose:

This document provides information to industry about how the proposed regulatory amendment to the Food and Drug Regulations, C.01.004.02(1) the requirement for a Fact Table, will be applied by Health Canada.  It is intended to complement the regulatory proposals which have been published in Canada Gazette Part I for consultation and will provide direction to industry regarding the specifics of the proposed provision.

Note: proposals and approaches may be modified as a result of consultation feedback. More detailed information on how Health Canada will implement these regulatory amendments will be provided through guidance documents, which will be available for consultation prior to publication of the amendments in Canada Gazette Part II.

Context:

The proposed amendments to the Food and Drug Regulations are part of Health Canada's Plain Language Labelling (PLL) Initiative.  The initiative is a multi-phased project that aims to improve the safe use of drugs by making drug labels and packaging information easier to read and understand. Some of the proposed regulatory provisions under PLL strengthen existing requirements, while others are new.  The requirement to provide a Fact Table is new.

This project is an important step in modernising Canada's drug regulations, guidance documents and information.  These coordinated measures will improve transparency while offering health benefits to Canadian families.

The Plain Language Labelling Initiative is an early deliverable under the Regulatory Roadmap for Health Products and Food.  The Roadmap is a strategy to produce a sustainable regulatory future with the dual objectives of protecting the Canadian public from the sale and advertising of unsafe food and health products, and supporting the safest consumption of food and use of health products.

What is the regulatory provision?

The current proposal amends C.01.004.02 to include a requirement for either a bilingual Fact Table or separate English and French Fact Tables on the inner and outer labels of nonprescription drug products. The Fact Table must also include information on:

• the adequate directions for use of the drug
• a quantitative list of medicinal ingredients
• the non-medicinal ingredients in a prescribed order
• how to report harms suspected to be related to the drug and
• how to contact the person in Canada who will receive the reports and any inquiries.

What is the intent of this regulatory provision?

The intent of this provision is to provide Canadians with required information in a standardised, easy to read format on inner and outer labels. Organising the information in a Fact Table will support quick, clear access to important information for nonprescription drug products.  Easy access to critical information for nonprescription products supports the goal of reducing preventable medication errors and related harms.

Which products would be affected by this regulation?

The scope of this provision includes nonprescription drug products for human use in dosage form (both Division 1 and Division 8).  However, for the purpose of this regulatory amendment, the following are exempt: nonprescription drug products administered only under the supervision of a practitioner, hard surface disinfectants, radiopharmaceuticals, biologics and extraordinary use new drug submissions.

When would this come into force and why?

The regulatory amendment for a Fact Table, like all amendments affecting nonprescription products, would come into force three years after the day of registration in Canada Gazette Part II, to allow industry stakeholders time to use up existing label inventories.

How will this be implemented?

The intention is that after the date of coming into force, all new Division 1 applications and Division 8 submissions [Drug Identification Number Applications (DINA), New Drug Submissions (NDS), Abbreviated New Drug Submission (ANDS)] for nonprescription drug products  will be required to include a Fact Table as part of their submission.  Given the related proposed regulatory provision for label mock-ups (C.01.014.1(2)(m.1), it is anticipated that the Fact Table would be included as part of those elements of the submission.  Greater specificity regarding the requirements of the Fact Table will be set out in a guidance document and are likely to include: expectations regarding acceptable font size, the use of colour contrast, critical elements to be included in the outer label along with formatting concerns.  Special provisions for containers with reduced size are also likely to be included in the guidance.  A draft guidance document on the Fact Table will be provided for consultation prior to the publication of the regulatory amendments in Canada Gazette Part II.

For products currently on the market, there will be a transition period to provide sponsors with the opportunity to use up their current stock of labels.  Sponsors will be encouraged to adopt the use of the Fact Table as they make label changes and/or use up existing inventories.  Voluntary compliance prior to the transition date will not be reviewed unless other major changes have taken place. After the coming into force date for this regulatory provision, (currently set as three years), the expectation is that all labels for nonprescription drug products will feature the Fact Table.

What additional information will be available?

The proposed approach includes the development of a guidance document for industry outlining specific requirements for the Fact Table. The intention is to have the Fact Table mirror the version in use in the United States for nonprescription products since 1999. The United States Drug Fact Table includes warnings, indications for use, storage conditions, etc. in an easy to read format.

Additionally, several Health Canada guidance documents are anticipated to require revisions to reflect the new regulatory provision, including the following:

• Management of Drug Submissions;
• Labelling of Pharmaceutical Drugs for Human Use;
• Guidance Document on Post-Drug Identification Number (DIN) Changes;
• Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document;
• Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format.

Please note that draft versions of new guidance documents and those which require significant revisions will be posted for comment prior to Canada Gazette Part II.

Are there any links to other proposed amendments?

There is a connection between the requirement for a Fact Table and the proposed amendment to C.01.004.01, which will require that labels of drugs for human use in dosage form contain information on how to report any harms suspected of being associated with the drug's use and the contact information for where to report.  Products which are required to have the Fact Table will need to include this information as part of the table.

The Fact Table requirement is linked with the new provision at C.01.014.1(2)(m.1), the requirement to submit mock-ups of outer labels at the time of submission.  Products which require a Fact Table will need to submit a scale mock-up of the label including the table as part of their submission package.

For nonprescription products, the Fact Table, mock-ups and information about reporting suspected harms will all come into force three years after the amendments are registered in Canada Gazette Part II.

What is the consequence of non-compliance?

Failure to submit copies of the Fact Table with new applications/submissions after the coming into force of the regulatory amendments will result in a screening deficiency notice.

Failure to adopt the Fact Table after the transition date for products currently on the market is likely to trigger the enforcement process which is directed by the Health Products and Food Branch Inspectorate (HPFBI).  Under the current regulatory system, Health Canada has a stepped approach to addressing concerns with drug products, and has the ability to require that manufacturers stop selling products where there are concerns for the Canadian public.

What is done in other countries?

A similar requirement was developed in the United States after extensive consultation with health care professionals, consumers and industry.  Implemented beginning in 1999, the Fact Table has been fully in use since 2005 for nonprescription products.  As a result, Health Canada intends to model the requirements for the Fact Table on the requirements as set out in the United States Federal Rule.

Australia is also in the process of reviewing labelling for drug products and recently consulted with the public and industry about implementing a Fact Table in their jurisdiction.

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