Pharmaceutical Company Quickly Transitions 28 SKUs To Comply With New Labeling Requirements

By Vlad Spehar, Director of Business Development, Jones Healthcare Group

A large multi-national pharmaceutical company contacted Jones Healthcare Group for assistance in complying with new Health Canada regulatory requirements for labeling over-the-counter (OTC) products.

In January 2017, Health Canada adopted amendments to existing Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) for non-prescription, OTC drug products. The amendments and new guidance are commonly known as Plain Language Labelling (PLL) regulations. All OTC products at retail must be in full compliance by June 30, 2021.1 The pharmaceutical company contacted Jones well in advance of the effective date due to the volume and complexity of the program and to avoid placing their products at risk of non-compliance.

PLL regulations aim to improve the safe use of drugs by making labels and packaging easier for consumers to read and understand. These regulations share several commonalities with the OTC Drug Facts Label, required by the FDA in May 2002.

The project scope required bringing 28 SKUs that varied by dosage form, quantity, primary and secondary packaging, as well as therapeutic area – and each SKU had its own unique packaging demands and timeline to maintain an unaffected retail shelf presence - into compliance with PLL. Read how all 28 SKUs were delivered in accordance with the forecast timelines and the overall project was completed early.