Health Canada recently released the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products (GLPP Guide). The GLPP Guide was released as part of 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 Regulations.” As of June 13, 2017, the Plain Language Labelling Regulations are in force for non-prescription drugs. The GLPP Guide provides industry with guidance on how to comply with the new requirements set out as part of the Plain Language Labelling Regulations, including the specifications for the Canadian Drug Facts Table (CDFT), which must be included on the outer labels of products.
As part of Health Canada’s Plain Language Labelling Initiative (reported here), Health Canada will require 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 Plain Language Labelling Regulations, which includes the CDFT requirements set out in the GLPP Guide. The June 13 compliance date applies to new products, or products with a label change that requires issuance of a new DIN or notice of compliance (NOC).
Currently marketed products must comply with the Plain Language Labelling Regulations, including the CDFT requirements, at the retail level by June 30, 2021. The GLPP Guide notes that marketed products coming into compliance are not required to file a submission solely to comply with Plain Language Labelling Regulations, provided there no are label changes that would require a new DIN or NOC and that labels follow the standard CDFT format.
The bulk of the GLPP Guide provides information on current best practices in product label design and layout, the information contained on the label, and the design or choice of package.
For more information, please contact your IP/Life sciences or healthcare practice professional at Norton Rose Fulbright Canada LLP.