Health Canada recently published a new Guidance Document that provides information on how Health Canada interprets and applies the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) (colloquially known as the Plain Language Labelling Regulations or PLL Regulations) for non-prescription (i.e. over-the-counter or OTC) drug products.
The Guidance Document, entitled Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs (the Guidance Document), is effective as of April 1, 2020. It identifies information that will support requirements mandated under the PLL Regulations, and points to other FAQs, guidance documents, and language that sponsors should to look to when making submissions or assessments.
The PLL Regulations aim to improve the safe use of drugs by making drug labelling and packaging easier to read and understand.
As we previously reported, the PLL Regulations require that that any new drug identification number (DIN) applications or supplemental new drug submissions for non-prescription drugs submitted on and after June 13, 2017 comply with the PLL Regulations. The PLL Regulations do not apply to medical devices, veterinary drugs, drugs that are represented as being solely for use as a disinfectant on hard, non-porous surfaces, or natural health products.
Overview of the Plain Language Labelling Requirements
Under the PLL Regulations, health product sponsors must:
- prominently display any required information and express it in plain language;
- provide information in an easy-to-read, comprehensible format;
- assess the proposed brand name of their drug as against other existing drug brand names, common names, or proper names so as to avoid confusion;
- provide contact information for someone responsible for the drug product in Canada on every label, indicating how to report harms;
- submit mock-ups of inner/outer labels (including package inserts), the product monograph, and packages for review by Health Canada; and
- display a Canadian Drug Facts Table (CDFT) on the outer label of a drug product.
By June 30, 2021, at the retail level, all OTC drug products must be in full compliance with the PLL Regulations.
The Guidance Document
The Guidance Document provides:
- an overview of the PLL Regulations’ requirements, including the rationale behind, and information that will support and satisfy each obligation;
- cross-references to other public resources that contain examples and model content;
- recommendations on language or information sponsors should look to and rely on when making their submissions;
- definitions of any ambiguous or unclear terms (i.e. Look-Alike Sound-Alike names); and
- answers to frequently asked questions relating to requirements and Health Canada’s evaluative procedures and expectations (e.g. explaining the precise location, phrasing, and formatting of certain required elements of drug products’ labels and, where applicable, exploring any flexibilities or exceptions available in relation to the different steps and components of sponsors’ submissions).
For instance, for the CDFT requirement, Health Canada encourages sponsors to consult the Guidance Document: Labelling Requirements for Non-prescription Drugs (the Labelling Requirements Document) for examples of standardized CDFTs and what should be included. The Labelling Requirements Document also provides wording that sponsors can use as a starting point for all submissions.
Link to Guidance Document: