Drug Safety Institute's President of Canadian Regulatory Affairs on the Impact of the Quebec's Bill 96

MIAMI, Oct. 18, 2022 /PRNewswire/ -- Drug Safety Institute's President of Canadian Regulatory Affairs, Scott Sawler, is pleased to offer insight on how the Québec legislation, An Act respecting French, the official and common language of Québec may impact the use of trademarked drug brand names on product packaging.

The practical effect of this legislation is determined by whether the drug brand name is a registered trademark:

• If it is registered in English, the brand may appear on the product label without a corresponding French equivalent.
• If the brand name is registered in English and also in French, the French version must also appear on the product label.
• If the brand name is not registered, it must appear on a product label with a corresponding French equivalent in the same or greater prominence.

It is important to note that this legislation will also impact the use of modifiers, especially when an unbranded modifier is used with the drug brand name (e.g., tablets). In this scenario, a French version of the modifier (e.g., comprimés) must also appear on the package or label with the same or greater prominence. If the modifier or drug brand name is invented, there is no English or French translation.

Mr. Sawler joined Brand Institute in 2017. He served as Director General of the Marketed Health Products Directorate before joining DSI.

Brand Institute is the global leader in pharmaceutical and healthcare-related name development, with a portfolio of over 4,000 marketed healthcare brand names, 1,300 USAN/INN nonproprietary names for 1,200 clients. The company partners on over 75% of pharmaceutical brand and nonproprietary name approvals globally every year with healthcare manufacturers.

Drug Safety Institute is composed of former naming regulatory officials from global government health agencies, including Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), American Medical Association (AMA), and the World Health Organization (WHO). These regulatory experts co-authored the name review guidelines while with their respective agencies, with many responsible for ultimately approving (or rejecting) brand name applications. Now working for a private company, these professionals provide Brand Institute's clients with industry-leading guidance pertaining to drug name safety (i.e., preventing medication errors), packaging, and labeling.

Contact:
James Dettore
Chairman & C.E.O.
[email protected]
www.brandinstitute.com

SOURCE Brand Institute, Inc.

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