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Life Sciences 10.19.17 BLOG 

Product Monographs in Canada – What to Know Now

By The TransPerfect Life Sciences Team

Bilingual Health Canada Labeling

Product Monographs in Canada – What to Know Now

The Canadian healthcare market is unique in several ways: with a bilingual patient and doctor population, language laws that mandate bilingual communication, and a complex regulatory process, pharma companies face many challenges when releasing drugs in Canada. Health Canada (the government department responsible for national public health) released guidance in March 2017 on plain language labeling, in addition to changes to the product monograph – the holy grail of Canadian pharma. Here’s what you need to know:

1. Follow the leader.

There have been several updates to the Health Canada product monograph template since 2004 (in 2010, 2014, and most recently, in 2016). Under the new Health Canada guidance, pharma companies are asked to follow the 2016 template, which includes changes to Part I and II. Both sections were reorganized for simplicity and readability for healthcare professionals. Additionally, Part III was revised to improve plain language, a ‘Summary of Changes’ section was added, and the format was revamped.

2. It’s a balancing act!

Make sure your marketing materials align with your balance copy. The Pharmaceutical Advertising Advisory Board (PAAB) will always flag inconsistencies and return for revisions before approving. To avoid wasting resources, ensure you build your marketing materials based off of the balance copy—this refers to the presentation of truthful and fair risk, and benefit assessment of the drug. Your translation providers will also check this for you and flag any inconsistencies—to provide proper checks and balances to help get your drug to market.

3. Appearance is everything.

Move away from Word documents. Like the rest of the world, Health Canada is modernizing their processes—shifting from paper to digital documentation. Specifically, they are looking to migrate from Microsoft Word to PDFs, and even XML format. Most product monographs aren’t printed anymore, making it more important to ensure appropriate formatting in the digital version. Always double check that all links within your product monograph work. Your translation provider can also update the formatting as needed.

4. Engage everyone early.

Start working with your translation provider while your product monograph is in draft form, since there is limited time between submission of your English version and the deadline for translation. You will want to send your product monograph as early as possible, to start the translation and hit the Health Canada deadline.
 

Your translation provider regularly checks and partners with Health Canada to understand any regulatory changes, and can help ensure your English and French product monographs are submission-ready! Remember, collaborate early and often with your translation provider to bring your drug to the Canadian market. For more information, contact TransPerfect’s subject matter experts at regulatory@transperfect.com .


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