From April 1, 2020 Health Canada has updated licensing fees and the registration of medicines and Medical Devices according to the consumer price index. It consists of a significant increase in tariffs that are implemented as part of a “cost recovery process” that includes fee mitigation measures.
This update has a significant impact on the “small business” eligible for exemptions and commission reductions.
the “small business”
Commissions applicable from April 1, 2020
Fees apply only to licence applications for Class II, III and IV Medical Devices. Class I Medical Devices, tailored, for special access and for investigative tests on human subjects are exempt from licences for which feeds do not apply.
The fee shell be based on the date of filing of the application, that is the date on which Health Canada considers that the application is complete according to the required standards. For example, if Health Canada receives an application on March 16, 2021, but they are required adjustments for which it is considered complete only on April 5, 2021, the applicable fee shell be the fee in force on April 5, 2021.
In the “Medical Device Licence Application Review Fees” document, published on the Health Canada website, they are shown the applicable commissions from April 1, 2020.
Invoicing and payment of fees
The fee payable to Health Canada should be paid only in Canadian funds. Payment can be made with credit card, check, postal order, bank transfer or directly at a financial institution.
Manufacturers of Medical Devices shell fulfil a commission format to be submitted with each application. Health Canada carries out a preliminary examination, verifies and adjusts the commission, if necessary, then it issues an invoice. Payment must be made within 30 days from the date of issue.
More information on the commissions payment are described in the “How to Pay Fees for Health Products” document published on the Health Canada website.
Mitigation measures for the “small business”
There are cancellations or reductions in fees for applications submitted by: a small business, publicly funded health institutions and a branch or agency of the Government of Canada or a province.
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.
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.
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.
Companies that satisfy these requirements are entitled to:
- Free sending of the pre-market evaluation for the first presentation/application/notification;
- 50% reduction for all pre-market evaluation fees;
- 25% reduction for all commissions on the right to sell;
- 25% reduction for all establishment licence fees.
If you want more information on how these changes can impact on your company, contact us to schedule a consultation at the phone number 0542 643496 or by e-mail at sales@thema-med.com
Sources:
https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees.html
