The Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) – more commonly known as the “Plain Language Labelling amendments” – as the requirements apply to prescription drugs and products obtained through a health care professional “came into force” on June 13th, 2015.
Health Canada introduced the regulatory amendments in July 2014 as part of its Regulatory Transparency and Openness Framework and its commitment to make information more readily available to Canadians. The Plain Language Labelling amendments aim to improve the safe use of drugs and help reduce preventable harms from medication errors by making drug labels and safety information easier to read and understand. These regulatory amendments also bring Canadian drug labelling requirements in line with international standards, namely the United States and Europe.
What is “plain language” labelling?
Plain language refers to a clear style of writing that is intended to be easily read and understood by the target audience. For example, the patient information section of a Product Monograph should be written at a reading level for grades 6 to 8. The plain language requirements not only include the clarity of the actual text, but also how the information is set out on the label, the use of design elements (color, contrast etc.), white space, and font face.
The amended regulations include five core requirements that a manufacturer must comply with during the pre-market submission period. These five core requirements include:
- Compliance with plain language labelling provisions that explicitly link the readability of the product label to the factors such as clear writing, color contrast, font size and layout. See section A.01.017 of the Food and Drug Regulations (C.R.C., c. 870) (“FDR”).
- Submission of a full mock-up of the product label and packaging intended to be used for the sale of the product. The submission allows Health Canada to review an accurate representation of what the product will look like when it becomes available in the Canadian market in advance of approval. See FDR sections C.01.014.1(2)(m.1) and C.08.002(2)(j.1).
- The requirement to include the contact information of someone who is responsible for the product in Canada should a patient experience a problem, or have a question or concern about the drug product. See FDR section C.01.004.01(1).
- Submission of a Look-alike Sound-alike (also referred to as “LASA”) assessment of the proposed product name. See FDR sections C.01.014.1(2)(o) and C.08.002(2)(o). Similarities between product names can cause health care professionals and patients to confuse one product for another, and can result in prescribing errors, transcription errors, dispensing errors and/or patient self-selection errors. The mandatory LASA assessment helps to ensure that the drug brand name will not be confused with another drug’s brand, common or proper name due to similar sounding or looking names.
- For non-prescription products, the inclusion of a standard drug information table which must contain information such as indications or uses, recommended doses, route of administration, storage conditions, a list of medicinal and non-medicinal ingredients, and contact information to allow patients to report problems. See FDR section C.01.004.02(1).
The Plain Language Labelling amendments codifies the five previously policy-based core requirements, thus bringing them under the FDRs with Health Canada oversight. Drug manufacturers of prescription drug products have already had a one-year transition period to plan for, adjust and implement the new mandatory plain language labelling provisions. For non-prescription products, there is a three year transition period (ending in June 2017) for compliance with the plain language labelling requirements.
In order to provide support and direction to manufacturers on how to comply with the plain language requirements and establish details respecting the amendments, Health Canada has created various policies and guidance documents, such as, “Guidance Document Labelling of Pharmaceutical Drugs for Human Use” (January 2014), the “Guidance Document for Industry – Review of Drug Brand Names” (Released July 2, 2014, effective June 13, 2015) which is now fully implemented, and the “Good Label and Package Practices Guide” which is currently in draft form. As the plain language labelling requirements are implemented, Health Canada will likely provide for further guidance to help manufacturers design safe and clear labels to establish consistent practices across the industry.