Draft guidance on the plain language labelling regulations for prescription drugs: Contact information requirement

On this page

• From the regulations
• Purpose of this requirement
• Required contact information
• Required wording
• Location of contact information

From the regulations

The following sections are from the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) (regulations).

Section C.01.004.01 (1) states that every label of a drug for human use in dosage form shall display a:

1. telephone number, email address, website address, postal address or any other information that enables communication with a contact person in Canada and
2. statement to the effect that any injury to a person's health that is suspected of being associated with the use of the drug may be reported to the contact person

(2) Subsection (1) does not apply to the labels of a drug that’s listed in Schedule C or D to the act and is in dosage form.

Purpose of this requirement

Drug labels must contain contact information. This requirement ensures that people in Canada are able to contact someone who is responsible for the product in Canada if they:

• experience a problem
  • such as an adverse reaction or medication error that led to taking the wrong drug or the wrong dose, for example
• have a question or concern

This requirement applies to prescription pharmaceutical drugs and those administered or obtained through a health care professional.

It does not apply to biologic drugs and radiopharmaceuticals.

Note: Sponsors are expected to report relevant safety information they receive about a drug to Health Canada. They must do so in a specified time and manner that complies with existing Canadian regulatory obligations.

Learn more:

• Reporting adverse reactions to marketed health products – Guidance document for industry
• Preparing and submitting summary reports for marketed drugs and natural health products – Guidance document for industry

Required contact information

Sponsors must provide at least 1 method of contacting the person in Canada, in both official languages. One of the following means of contact is recommended:

• toll-free number
• email address or
• website

If there’s limited spacing on a package label, a sponsor may use their postal address. This satisfies both the plain language labelling regulation (C.01.004.01(1)) and existing regulation (C.01.004.1(c)(i)).

Required wording

One of the following statements is recommended in both official languages:

• "For questions or to report problems, please contact" or
• "Questions or concerns"

If space is limited, one of the following bilingual versions of the statements may be used:

• "Concerns/Questions/Problèmes" or
• "Concerns/Questions/Préoccupations"

Statements should be followed by the contact information. The sponsor can decide who the contact person located in Canada will be.

Note: The name of the contact person in Canada doesn’t need to be listed.

Location of contact information

The contact information should be displayed on the inner and outer labels.

Note: Under section C.01.004 (3), special containers, such as blister packs, and small containers are exempt from this requirement.

Peel-back labels

The information should be on the top layer if there’s enough space. Otherwise, it may be on another layer.

Existing authorized labels

The information should be added when an existing label is being revised.