Health Canada has proposed an amendment to the Food and Drugs Act as part of their Plain Language Labelling (PLL) Initiatives. The aim of this project is to better convey drug information to the consumer in an easy to understand format.
The regulatory provision for the proposed amendment requires a mock-up label at the time of the drug submission. A mock-up label includes packaging, package inserts, and supplementary information presented in the actual size in full colour with the intended graphics and fonts. The intent of submitting a mock-up label is to support pre-market filings with accurate representations of what will be accessed by consumers and health care professionals.
The requirement to submit mock-up labels is intended for DINAs, NDS’, ANDS’, and EUNDS’. Failure to submit a mock-up label will result in the submission being rejected at time of screening.
The deadline to submit comments to the Bureau of Policy, Science and International Programs, Health Canada is September 6th, 2013.
In addition to these changes, the PLL project wants to further target areas of consumer drug communication. This will include:
- Changing accessibility of the consumer section of the Product Monograph to a separate section on the Drug Product Database
- Revising the format of consumer information on prescription drugs to be easier to read and understand
- Improving prescribing information for healthcare professionals to easily access critical information
- Implementing a Facts Table for OTCs for pertinent information regarding the drug
The PLL initiative will garner several changes in the upcoming months to align proposed amendments with standardized procedures. Focal Point Research Inc. has the expertise to creatively provide solutions to your product packaging and labelling requests. Contact one of our experts at (905) 271 – 2709. We’d be happy to assist you with your product inquiries.