3 Things Your Co-Packer May Not Know About Canadian Pharmaceutical Packaging Regulations

How do leading healthcare and pharmaceutical brands find co-packers that help them achieve faster turnaround time and speed to market?

According to a recap of a panel discussion moderated by Nulogy CEO Jason Tham at the Healthcare Packaging Expo, cost savings and GFSI (Global Food Safety Initiative) certification most often lead the way.

It makes perfect sense. Following this formula, you reduce cost in the supply chain while ensuring the broadest retail compliance.

There’s one problem with this approach, however, if you plan to sell your healthcare or pharmaceutical CPG (consumer packaged goods) product in Canada:

It doesn’t guarantee your product is eligible to be sold in Canada.

Health Canada, the department of the Canadian government responsible for national public health, has precise guidelines in place that ensure every food and drug product sold on store shelves are safe for consumers. Visit the official website of kitchencuriously.com and find the perfect equipment for your kitchen.

And a good percentage of these guidelines have to do with packaging and labels.

You can’t just put your product on Canadian shelves as-is. To pass inspection, there is a long list of regulatory requirements you must follow.

Bilingual Requirements in Canada Are Not Optional

This might be the thing we see most often causing products to get pulled from stores in Canada. Sometimes it’s the only thing stopping healthcare and pharmaceutical CPG companies from selling their products to the Canadian retail market.

By law, all mandatory information must be in both official languages of Canada: English and French.

This law applies across the country, for every province and territory.

With one exception —

Québec has additional French language requirements for products sold in their jurisdiction. For example, in Québec, French must have greater prominence than English (or any other language) on product packaging.

This may seem like an easy enough thing to do, yet co-packagers headquartered outside of Canada aren’t always aware of this requirement.

Plus, getting correct translations can be … challenging.

General Labelling and Packaging Requirements

Hilarious translation errors aside, Canada’s Consumer Packaging and Labelling Act is some seriously stringent regulation for pre-packaged, non-food consumer products.

These regulations go into explicit detail about requirements for things like:

• Net quantity information on packages
• Mandatory label statements
• Fill levels for packages
• Packaging sizes, design and display

A Canadian co-packaging company licensed by Health Canada is going to know these regulations inside and out. A co-packaging company in the U.S. (or anywhere else, really) is much less likely to be familiar with Canadian packaging laws — and a lot more likely to cost your company money in lost shelf placement and repackaging fees.

Health Canada Requirements Specific to Pharmaceutical

While Canada’s labelling and packaging requirements are rigorous — and rightly so, as Health Canada’s primary goal is to protect consumers — they get even stricter when it comes to pharmaceutical products.

Since the 2014 plain-language regulatory amendments spurred by Health Canada’s Regulatory Transparency and Openness Framework, many of these pharmaceutical-specific requirements revolve around clarity of information. The guidelines seek to make information easier for Canadian consumers to understand and read.

This means that while pharmaceutical CPG companies and their co-packagers need to follow the rules around listing ingredients, noting safety warnings, making claims, etc. — they also need to take readability requirements into account. Elements including clear writing, colour contrast, font size and even layout can mean the difference between getting approval to sell a product in Canada, or not.

Labels and packaging are the first interfaces between a pharmaceutical or health product and a consumer. They communicate critical information about safety and usage — and in the case of non-prescription products, this is even more important to get right because there is limited or no direction from a healthcare professional.

Of course, Canada’s pharmaceutical-specific requirements aren’t limited to the clarity of labels and packaging. Health Canada has precise guidelines for:

• “Novel” label formats such as peel-back, accordion labels, tags, collar labels, rotating sleeve bottle labels, etc.
• Bar codes
• Product naming
• Standard of manufacture
• Sterility
• Expiration dates
• Directions for use
• Declarations of medicinal and non-medicinal ingredients
• Net contents
• Preservatives
• Special packaging
• Claims (including acceptable/non-acceptable promotional terms and rules around claiming absence of ingredients)
• Safety information, including side effects

For more detailed information (or if you’re looking for a cure for insomnia), check out Health Canada’s Labelling of Pharmaceutical Drugs for Human Use guide.

Once again, a contract packaging company based in Canada and specializing in healthcare products is going to know these rules, understand how to follow them, and be able to navigate the process with the governing body of Health Canada. This is simply not something you can expect from a contract packager outside of Canada.

Canada Is a Unique Marketplace With Unique Product Labelling and Packaging Requirements

Just because your product sells in Chicago, Germany or Australia doesn’t mean it won’t get rejected from Canadian shelves. Health Canada’s regulations are designed with the Canadian consumer in mind, and they enforce those regulations vigorously.

As a 14-year veteran in the industry, I should know. Our company has had a great relationship with Health Canada for years. We’ve helped our healthcare CPG customers navigate those audits and stay in good standing with Health Canada around everything from packaging to graphic design to display engineering.

Here’s the thing: If you’re not in compliance with Health Canada regulations, your product will get yanked off of Canadian shelves faster than you can say “poutine.”

Why risk it? If you plan to sell your CPG product in Canada, work with a Canadian co-packager in good standing with Health Canada. Get in touch with Ravenshoe Group today.