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Advisory Board. Health Canada recently updated its fact sheet on biosimilars, including new or clarified information about key topics including interchangeability and switching.
The fact sheet incorporates a decision the Canadian regulator made earlier this year, when it updated its naming convention for biosimilars, deciding that all biologics, including biosimilars, will be identified by their brand names and nonproprietary names without the addition of a product-specific suffix.
The regulator says that both the brand name and nonproprietary name of any biologic product should be used at all times so that products that share the same nonproprietary name can be differentiated by their brands. Identification of biosimilars and biologics is particularly important for prescribing, dispensing and adverse drug reaction reporting, Health Canada says, adding that as more biosimilars enter the market, there are more products with the same non-proprietary name. In regard to interchangeability, Health Canada notes that the term typically refers to the ability for a patient to be changed from one drug to another equivalent drug, usually at the pharmacy level, without the intervention of the prescriber.
In Canada, the authority to declare 2 products interchangeable rests with each province and territory according to its own rules and regulations, the regulator says, and it is not equivalent to the authorization of a biosimilar.
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Careers fairs. TSG can help Regulatory product jurisdictional mapping Prepare and submit registrations Strategy development for addressing data requirements Develop and review labels. Need help ensuring your products comply with Canadian regulations? Contact us.
Product Licensing (Canada DIN; USA OTC/Homeopathic) - NHP Consulting
Meet our consultants. Gentiane Violet Liquid Topical is an antiseptic used to treat infections of the skin and mucous membranes. This product is also known to be used by some nursing mothers to treat oral thrush in infants. The manufacturer has voluntarily stopped marketing this product in Canada and its product licence has been cancelled.
The manufacturer indicated that the product was no longer available on the market, so no recall was required.
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These products were used to treat surface wounds and eye infections in food-producing and companion animals e. All manufacturers have voluntarily stopped marketing these products, their product licences have been cancelled, and any products that were on the Canadian market have been recalled.
Medical Devices: There are currently three licensed medical devices on the market that contain gentian violet. They are all made by one manufacturer Hydrofera. The risk assessment for these devices found that the gentian violet is unlikely to come into direct contact with the skin, therefore these products do not posean increased risk of cancer when used for a short time and in most people.
United States
The Department has requested that the manufacturer update the product labels to state that these products should not be used for longer than six months and should not be used by pregnant or nursing women as a precaution because of the lack of information available to support these uses. Should the Department identify unauthorized health products containing gentian violet being sold in Canada , it will take appropriate and timely action to protect the health and safety of Canadians.
For further information: Media Inquiries: Health Canada, , hc. Information Update - Health Canada seized "Plasmajet", an Media Advisory - Canadian War Museum to livestream ceremony in