By Chris Johnston, Senior Account Executive – Carton & Labels, Jones Healthcare Group
Any change to packaging design for an approved pharmaceutical product is a time consuming, detail-orientated effort, even with small brand-driven changes––so when governments update packaging regulations on a larger scale, a company’s entire product line could be impacted, creating change management projects for sometimes hundreds of items. What’s more, if updated regulations introduce new requirements for packaging, this not only adds another layer of complexity, but also presents a significant challenge to any organization given the significant internal resource time and workload necessary to manage changes at this scale.
That’s why when Health Canada introduced amendments to the existing Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) for non-prescription, over-the-counter (OTC) drug products in 2014, pharmaceutical organizations selling products in the Canadian marketplace knew they had a significant challenge to overcome.
The government implemented this new guidance, known as Plain Language Labelling regulations or PLL, to improve the safe and effective use of non-prescription drugs by making packaging easier to read and understand. The regulations include new requirements for what information is included on outer packaging and how the information should be formatted.
While there are several staged implementation periods, the overall compliance deadline for all OTC products at the retail level is June 30, 20211. This means there is not only a high volume of packaging to redesign, but also a tight timeline to complete the necessary changes.
With this in mind, a large, Multi-National Pharmaceutical Company engaged with Jones Healthcare Group to develop and implement a turnkey packaging solution that would provide full compliance to the new Health Canada PLL regulations well in advance of the deadline.