The Plain Language Labelling requirements came into effect June 13, 2017 for non-prescription/Over-the-Counter drugs, biological drugs and radiopharmaceuticals (though this initially started with prescription drugs on June 13, 2015) in Canada. The goal of the PLL was keep language simple and easy-to-ready which ultimately would reduce risk to consumers who may otherwise have difficulty reading or interpreting a drug label.
One of the changes includes a reformatted Canadian Drug Facts Table (CDFT). When a Drug Identification Number (DIN) application is submitted a mock label must also be submitted. This mock label must be bilingual and contain the correct font size, colour and type. Labels are provided in editable format in order for Health Canada to make notes on the pdf.
Quality Smart Solutions can ensure your drug application contains the PLL format label when submitted to Health Canada.