Notice: Guidance Document: Labelling Requirements for Non-prescription Drugs
September 28, 2018
Through Health Canada's Plain Language Labelling (PLL) Initiative, there are new requirements for health product labelling and packaging, including a requirement for a Canadian Drug Facts Table (CDFT) on the outer label of non-prescription drugs. The Guidance document: labelling requirements for non-prescription drugs will assist manufacturers, packagers, and distributors of non-prescription drugs in developing plain language labelling content for a CDFT in a standardized format so that consumers can find important product information quickly and easily.
CDFTs for active ingredients found in non-prescription drugs in Canada are available. The CDFTs illustrate the application of plain language principles and show how current non-prescription drug labelling information must be presented to accommodate the formatting specifications of the CDFT. The content of the CDFTs reflects the most current labelling information for the listed non-prescription drug ingredients, based on the current safety profiles, use of plain language, international alignment, and experience to date. Product labelling submissions must reflect this current knowledge. The acceptable formatting specifications for the CDFTs are also included in this guidance. The language used in the CDFTs is strongly recommended, though other statements to the effect of what is presented may be acceptable.
This guidance may be used in conjunction with the Health Canada Guidance Document: Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products (GLPPG). The GLPPG outlines best practices for labelling and packaging non-prescription drugs and natural health products.
This guidance document does not replace the different submission types that currently exist for non-prescription drugs. For performance targets associated with different submission types, please consult Health Canada's Guidance for Industry- Management of Drug Submissions.
Submissions
Health Canada requires that for non-prescription drugs, any new Drug Identification Number (DIN) applications or (Supplemental) New Drug Submissions submitted on and after June 13, 2017 be in compliance with the PLL regulatory requirements which include the presence of the CDFT on the product labels. This applies to new products, or marketed products with a substantive enough label change that the issuance of a new Drug Identification Number (DIN) or Notice of Compliance (NOC) is required. For details on the requirements related to submission filing, please consult Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs.
Marketed Products
All non-prescription drug products on the Canadian market as of June 13, 2017 must be in full compliance at the retail level by June 30, 2021. Marketed products coming into compliance are not required to file a submission solely for the purpose of complying with PLL, provided there are no substantive label text changes (i.e., label changes that would require a new DIN or NOC) and that labels follow the standard CDFT format. Marketed Category IV monograph products as well as mouthwash and toothpaste, are not required to file a submission solely for the purpose of complying with PLL, provided there are no substantive label text changes (i.e., label changes that would require a new DIN) and that labels follow the Category IV CDFT flexibilities. If there are substantive changes that would require a new DIN or NOC, a submission must be filed.
Should you have any questions or comments regarding the content of the guidance, please contact:
Natural and Non-prescription Health Products Directorate
Health Products and Food Branch
Graham Spry Building
250 Lanark Avenue
Postal Locator: 2003A
Ottawa, Ontario K1A 0K9
Facsimile: 613-954-2877
E-Mail: NNHPD_DPSNSO@hc-sc.gc.ca