February 20, 2019

Why Health Canada’s Updated Plain Language Labelling Requirements Are Good for Business

Ever feel like you need a magnifying glass to read the label on a bottle?

If so, you’re not alone. In fact, trying to decipher the information crammed onto the packaging of any over-the-counter healthcare product is often an exercise in confusion and frustration for consumers.

And it’s not just the size of the print. It’s the ingredients, the directions for use, even the problem it’s supposed to solve!

Product packaging — especially the label — is one of the first points of interaction that a consumer has with a product. Making the information on the label clear and concise is crucial. Consumers need to know who and what the product is for, and how to use it, so they can determine whether or not it’s going to meet their needs.

This is true for any consumer packaged good (CPG) — but with pharma/ healthcare products, the stakes are even higher.

Labelling on the products needs to communicate much more about the product than just its benefits. It must provide information about the safe and proper use of the product as well.

From print that’s too small to read, to medical terms that laypeople don’t understand, how information is presented on healthcare product labels can mean the difference between the intended outcome and an adverse medical event — even for over-the-counter products.

Health Canada took this challenge seriously with their recent labelling initiative.

Plain Language Labelling: A Powerful Remedy

In an effort to improve the safe use of health products among Canadians, Health Canada introduced the Plain Language Labelling (PLL) Initiative for prescription drugs in 2015, and updated its guidelines to extend regulations to more products last year. The regulations came into effect for non-prescription drugs on June 13, 2017, with a full compliance deadline of June 30, 2021.

The goal of the PLL initiative is simply to make the names, labels and packages for pharma/ health products easier for consumers to read and understand, thereby making their products safer to use.

In effect, the regulations are in place to help make sure that manufacturers are providing the right information, in the right place, so that anyone making a point-of-purchase decision will have all the data they need to make an informed choice.

For CPG’s, these new requirements might mean that you need to update your existing packaging and introduce newer packaging machinery. But the good news is that the new rules are common-sense, and a good packaging design company operating in the Canadian market (like Ravenshoe Group) can guide you through the process. Let’s take a look at the biggest changes.

1. Clear, Understandable, Plain Language

Let’s face it: Medical terminology and scientific lingo can be baffling to anyone who isn’t a scientist, a doctor or a pharmacist.

How is the average person looking for a remedy for “indigestion” going to know that the antacid package they’re holding is right for them, if the product label advertises a cure for “dyspepsia?” Basically, “plain language” just means that the label should use words that the general public understands the first time they read it, instead of a more technical term used in more scientific circles.

In addition, the information has to be prominently displayed.

Claritin Packaging

The simpler the language and presentation, the easier it will be for consumers to evaluate the product and decide if it’s what they need.

2. Standardized Table Format for Drug Facts

In the past, CPG manufacturers tended to present key product data in blocks of text on the packaging label, without much contrast between the text and the background. What’s more, the placement of the information on the label varied from product to product.

Needless to say, this made it difficult for consumers to read and interpret important information and decide if the product was right for them.

The updated PLL guidelines require manufacturers to display specific product information in an easy-to-read table format on the product label (similar to the Nutrition Facts table you see on food labels). This new standardized Facts Table is required on the inner and outer labels of non-prescription drugs, and must contain important information like active ingredients, indications for use, warnings and directions.

Displaying important information in a clear and easily-recognizable format will make it much simpler for consumers to interpret the data quickly.

3. Mandatory Contact Information

It may seem like a no-brainer for businesses to provide contact information on their product packaging, but for most CPGs, it’s been optional. Under the updated PLL guidelines, however, it’s no longer an option for non-prescription drug products — it’s compulsory.

The driver behind this requirement is the importance of providing a way for consumers to report problems or adverse reactions to the product manufacturer, or simply to request more information.

The means of communication can be a toll-free number, an email address, or even a website URL. Decisions around personal care can have far-reaching consequences, and it’s critical that consumers have a way of communicating with the companies making the products they’re using.

4. Submission of Mock-Ups for Review

Manufacturers who are submitting new drug product applications will now need to provide mock-ups of labels and packages to Health Canada for review.

Health Canada will assess the mock-ups against regulations governing font size, type, colour, and placement of information. The department’s Good Label Package Practices Guide for Non-prescription Drugs and Natural Health Products sets out detailed suggestions on design and layout specifications for font size, typeface, and text alignment — all to improve readability and comprehension for anyone using the information on the label to make a decision about its use in their own circumstances.

This requirement is not retroactive, and only applies to new submissions. The intent is to allow Health Canada to review the packaging and label information as consumers and health professionals will see it — and to head off any non-compliance issues before the product goes to market.

This need not be a headache. If you work with an experienced packaging design firm that has the in-house expertise and facilities to develop your label mock-ups, this requirement is easy to cross off your list.

Clearer Labels Are Good for Business

As anyone in the pharmaceutical or healthcare industry knows, safety is everything. And while your company already goes to enormous effort to ensure the safety of your products, appropriate labelling can mean the difference between consumers using your product properly or not.

User-friendly standardized formatting, inclusion of contact information for reporting problems or adverse drug reactions, and simpler language — these are all changes that will help your customers make informed decisions about your product, and increase their overall satisfaction with your brand.

Clear and honest package labelling builds trust, and trust builds loyalty. Need guidance in making sure your product labels meet the updated PLL requirements? We’re here to help— get in touch with Ravenshoe Group today.


  1. As anyone in the pharmaceutical or healthcare industry knows, safety is everything. And while your company already goes to enormous effort to ensure the safety of your products, appropriate labelling can mean the difference between consumers using your product properly or not

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