On June 30th, 2016 Health Canada released a final guidance document for the industry that will revise their regulations on Non-prescription drugs and natural health products. This newly released guidance is known as Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products (GLPPG) and it describes implementation timelines to when labels would need to be compliant in Canada.
For any health product you buy, reading the label is very important for helping you choose the right product along with properly understanding how to use it effectively and safely. Through Health Canada’s Plan Language Labelling Initiative, several new regulations such as the Plain Language Labelling Regulations have been implemented to communicate key information about new requirements for clear, understandable labels that are currently being phased into effect.
These new labelling changes will be phased in to the Canadian marketplace starting June 2017 and non-prescription drug products must be in full compliance at the retail level by June 2021.
This final document is provided in two sections; one for non-prescription drugs and natural health products, and the other is for prescription drugs. The main change is a new standardized Canadian Drug Facts table that will be a requirement for non-prescription drugs, as well as contact lens disinfectants. The concept and format of this new label will be similar to the Canadian Nutrition Facts table for foods and will be very similar to the table used for non-prescription drugs in the United States. The one key difference is that the table must also be in French. These amendments also include the addition of the company’s contact information on the label and the submission of label and package mock-ups.
It is important to note that while Natural Health Products are not covered under these new regulations, the guide does offer guidance for the proper design of a “Products Facts Table” for NHPs with a strong recommendation that these new labelling changes will be eventually applied. For consistency and as a good practice, sponsors may wish to adapt the Drug Facts table format to Natural Health Products although the table is not required under the Natural Health Products Regulations.
We hope that this information has been helpful to you. If you have any questions about requirements and want to see how we can help make this work for your packaging, please feel free to contact Focal Point Research. As leading scientists in this industry and qualified Drug Regulatory and Packaging Development Consultants, we work very closely with these types of products and regulations. You can trust us to help guide your company in the right direction.