Tax Reductions for the “small business”
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As of April 1, 2020, Health Canada will adopt measures for small business fee reductions for human and veterinary drugs and medical devices. To receive a fee reduction you must first apply for and receive small business status for each unique identifier. You will be invoiced the full fee if you do not apply for and receive small business status before submitting your submission / application / notification.
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In order to require the mitigation, Manufacturers must apply at the time of filing, indicating in the commission form the type of reduction requested. In the case of “small business”, Manufacturers must register themselves as small businesses and verify that their registration information is up to date.
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From April 1, 2020 tax reductions are provided to small businesses, medicines, human and veterinary medical devices. Reduced fees are charger to Manufacturers who meet the criteria of a “small business”; if, however, Health Canada defines that the Manufacturer no longer qualifies as a small business, the rate is to be paid in full.
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A small business is defined as any business with fewer than 100 employees or has between $ 30.000 and $ 5 million (CAD) in gross annual revenue.
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Companies that satisfy these requirements are entitled to:
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Free sending of the pre-market evaluation for the first presentation/application/notification;
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50% reduction for all pre-market evaluation fees;
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25% reduction for all commissions on the right to sell;
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25% reduction for all establishment licence fees.
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How we can help
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You can apply for small business status through MedTechGuys. You’ll receive an automatic status confirmation / rejection based on the small business definition.
Required information
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To register as a small business with Health Canada, we require you to give the:
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full legal company name
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unique identifier(s)
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business number (non-mandatory)
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annual gross revenue for your last completed fiscal year
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number of full-time or equivalent employees for your last completed fiscal year
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fiscal year end date
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affiliate status
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breakdown of the above information for each affiliated company
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contact information for all listed companies
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