Canadian non-prescription drug product labels must be truthful, accurate and not misleading, and require specific label information, some of which must be presented on unique panels (French and English). Recently, new regulations have been announced regarding the format of non-prescription drug labels, with a new “Drug Facts” type format required within the next two years.
The labelling of drug products, including non-prescription drugs, is governed by the Food and Drugs Act and Food and Drug Regulations and other minor regulations depending on the drug type. Non-prescription drugs, often referred to as Over-The-Counter (OTC) drugs, are drug products containing ingredients not listed on the Prescription Drug List and available without a prescription. This can include drugs that are sold to the general public without healthcare professional intervention, drugs sold to the general public with the intervention of a healthcare professional, and drugs that are sold directly to a healthcare professional intended for professional use.
Information on drug product labels must not be false, misleading, deceptive or likely to create a false impression regarding the product’s character, value, quantity, composition, merit or safety. Non-prescription drug labels must contain specific information and comply with placement requirements for this information. This required information includes the product brand name, proper or common name, drug standard if applicable and Drug Identification Number (DIN), all of which are required on the principal display (main) panel. Other information required to be included on any other label panel includes the net contents, name and address of the manufacturer/sponsor and distributor if applicable, lot number and expiry date, directions for use, a list of the medicinal ingredients and their quantities and a list of all non-medicinal ingredients. In addition, there are bilingual requirements (French and English).
Recently, an amendment to the Food and Drug Regulations was published in Canada Gazette II (Labelling, Packaging and Brand Names of Drugs for Human Use) in an effort to improve the safe use of drugs by making drug labels and packaging easier to read and understand. These new regulations require the outer label of all non-prescription drug products to have a Facts Table, similar to the US Drug Facts table and additional contact information requirements. This amendment was published in 2014 and will come into effect in 2017 for non-prescription drug products.
NHP Consulting Inc can provide current labelling consultations for OTC drug.