Health Canada has released a new guidance document intended to clarify new "plain language" labeling requirements before new regulations take effect on 13 June 2015.
In 2013, Canada's then-Minister of Health Leona Aglukkaq announced the government was launching a new initiative toimprove drug safety by making product information easier to understand for consumers.
Making labels and packaging easier to understand, Aglukkaq said, would "help prevent adverse drug reactions (ADRs), medication errors and protect Canadian patients." In launching the initiative, the government said "as many as 1 in 9 emergency room visits are related to drug adverse events, and as many as 68% of those are preventable."
Following the launch of the initiative, the Canadian government passed the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use, which included new requirements for plain language labeling.
Plain Language Labeling
Beginning 13 June 2015, new plain language labeling regulations will take effect in Canada for prescription drugs, including biologics and radiopharmaceuticals. While the regulations do cover non-prescription drugs, the requirements will not take effect for them until 13 June 2017.
In order to ensure drug labels are easily understood by consumers, the new labeling regulations require:
A.01.017 Every label of a drug for human use in dosage form shall meet the following conditions:
- The information that is required by these Regulations to appear on the label shall be
- Prominently displayed on it,
- Readily discernible to the purchaser or consumer under the customary conditions of purchase and use, and
- Expressed in plain language; and
- The format of the label, including the manner in which its text and any graphics are displayed on it, shall not impede the comprehension of the information referred to in paragraph (a).
Existing products will not be affected by the new regulations, as they do not apply retroactively, though the government expects existing products will eventually conform to the new regulations as labels and packages are updated. Additionally, the regulations do not affect other healthcare products such as medical devices, veterinary medicines or natural health products, which will retain current labeling requirements.
In addition to the plain language labeling requirements, the new regulations also require several other measures to reduce confusion for consumers.
New drugs will be required to be required to undergo a brand name assessment to ensure the drug "will not be confused with another drug because of similar names."
Companies will also be required to list contact information on all new drugs, excluding biologics and radiopharmaceuticals, in dosage form. Affected products must list at least one of the following: "a telephone number, email address, website address, postal address or any other information that enables communication with a contact person in Canada." Additionally, contact information must be presented in both English and French.
New product applications will now be required to include mock-ups of labels and packages, which Health Canada will review along with safety and efficacy data. This requirement will apply to all drugs, including biologics and radiopharmaceuticals, and will not be applied retroactively.
Each of these requirements will go into effect for prescription drugs on 13 June 2015, while non-prescription drugs will have until 13 June 2017 to comply.
Facts Table for Non-Prescription Drugs
The new regulations require all non-prescription drugs, excluding those "obtained only through health professionals," to include a facts table on the product's outer packaging. The label must be bilingual in English and French and provide:
- "Adequate directions for use of the drug;
- A quantitative list of the drug's medicinal ingredients by their proper names or, if they have no proper names, by their common names;
- The drug's non-medicinal ingredients listed in alphabetical order or in descending order of predominance by their proportion in the drug, preceded by words that clearly distinguish them from the medicinal ingredients; and
- The information referred to in subsection C.01.004.01(1) [Contact Information]"
As with the other requirements for non-prescription drugs, the fact table requirement will take effect on 13 June 2017.