Plain Language Labelling Regulations for Non-Prescription Drugs
Updating Canada’s PLL Regulations
By: Vicki Schofield, Regulatory Affairs Specialist, email
Beginning June 13, 2017, Plain Language Labeling Regulations came into effect for non-prescription drugs. The intention of these Regulations was:
- Simplifying and making the label text clearer for the consumer – Language is meant to be prominently displayed with labels and packages to be formatted and presented in a manner that does not prevent understanding of the information.
- Reducing confusion of “Look-alike – sound-alike” products – Health Canada will look at other product names to be sure there are no similarities that may lead the consumer to mistaken one product, particularly when self-selecting, prescribing, transcribing, etc.
- Ensuring consumers have direct contact details for reporting adverse events – this is required on both inner and outer labels,
These new Regulations have made drafting submission labels more complex for the Manufacturer. Mock-up labels now have to be included within the submission review period with details such as font size and type being reviewed. The requirements are different for different drug product types. Many clients are turning to Dell Tech to help navigate the increasingly complex regulations. Contact Dell Tech today for assistance.
Dell Tech has provided professional, confidential consulting services to the chemical specialty
industry in Canada, the USA, Europe, and Asia for the last 40 years.
Contact us today for more information.