Guidance on evaluation fees for human drugs and disinfectants: Invoicing, fee payment and mitigation measures

On this page

• Fee section template
• Fee payment schedule
• Mitigation measures

Fee section template

Sponsors must complete the fee section of the Regulatory Enrolment Process (REP) Regulatory Transaction (RT) template. Please consult the Regulatory Enrolment Process (REP) information page for more information. Be sure this is included in your submission or application.

The RT template provides a link to the fees, and includes a section on fee mitigation measures, When filing your submission, do not include payment.

When Health Canada receives the required documents, we will conduct a preliminary examination. We will verify the classification and issue an invoice for the applicable fee.

For most submissions, we will issue an invoice when the submission is accepted into the Review 1 stage. However, for administrative or labelling standard submissions, we will issue an invoice when we make our final decision. Payment is due 30 days from the date of the invoice.

If we reject a submission or application during the preliminary examination period (it's considered deficient at the time of screening), we will issue a notice of rejection. We will also issue an invoice for 10% of the applicable fee at this time.

If a submission or application is withdrawn after a Screening Deficiency Notice has been issued, we will issue an acknowledgement of cancellation. We will also issue an invoice of 10% of the applicable fee.

The full fee will be invoiced if a submission or application is withdrawn after we have either:

• issued a Screening Acceptance Letter or
• reached a decision on an administrative or labelling standard submission

Fee payment schedule

The following fee payment schedule applies:

• 0% before acceptance into review and no Screening Deficiency Notice has been issued
• 10% before acceptance into review but after a Screening Deficiency Notice has been issued
• 100% after a decision is made to issue a screening acceptance letter, or a final review decision is made for administrative or labelling standard submissions

Instructions on the payment of fees are further outlined in the how to pay fees page. All payments must be in Canadian funds. Cheques must be payable to the "Receiver General for Canada."

Sponsors wishing to dispute a particular fee should contact our Food and Drugs Act Liaison Office (FDALO).

Mitigation measures

Requests can be made to waive or reduce fees for submissions or applications filed by:

• a small business
• a publicly funded health care institution
• any branch or agency of the Government of Canada or of a province or territory
• organizations sponsoring drugs for the purposes of implementing Canada's Access to Medicines Regime under section C.07.003 of the Food and Drug Regulations

Requests can also be made to waive or reduce fees for:

• products on the list of drugs for an urgent public health care need as per the Access to Drugs in Exceptional Circumstances Regulations
• a COVID-19 drug for which an application was previously filed under the interim order for the same product

Sponsors must apply for mitigation when they file. Indicate the type of mitigation being requested in the fee section of the REP RT template.

For submissions or applications received before April 1, 2020, refer to Appendix A of the archived Guidance document Fees for the review of human drugs and disinfectant drug submissions and applications.

Small business

Sponsors will be required to register as a small business and ensure that their registration information is up to date.

Sponsors who meet the criteria of a small business will be invoiced at the reduced fees (see below). However, if we determine that the sponsor does not qualify as a small business, then the full fee will be due. In this case, we will issue an additional invoice for the difference between the full fee payable and the original invoice.

For a submission or application that was reviewed for free, we will issue an invoice for the full amount.

A small business is any business, including its affiliates, that has:

• fewer than 100 employees or
• between $30,000 and $5 million (CAD) in annual gross revenues

Note that the definition is an OR statement so you must meet one of the 2 qualifications. The annual gross revenues must also include all revenues and are not limited to the health products being licenced.

Sponsors that meet the above definition are eligible for a 50% reduction on all human or disinfectant drug submissions or applications.

Sponsors are also eligible for a "one-time only" waiving of fees for their very first submission or application filed with Health Canada.

First submissions that are withdrawn before the final decision is made or that receive a negative decision are considered to be the first filed submission. This means that future submissions will not be reviewed for free.

Sponsors must indicate on the REP RT template that they are requesting small business mitigation. They must also indicate if this is their first submission ever filed.

Before submitting a submission or application, sponsors must first apply for small business status through the Drug and Medical Device Small Business Application process. Those who have not been granted small business status at the time of filing will be charged the full fee.

When registering, please provide the following information:

• name of company
• annual gross revenue for last completed fiscal year
• number of full-time or equivalent employees for last completed fiscal year
• previous fiscal year-end date
• affiliate status
• breakdown of the above information for each affiliated company
• contact information for all companies listed

Affiliated companies are those that:

• are controlled by the sponsor's company, which holds 50% or more of the affiliate's votes or shares
• control the sponsor's company, where the affiliate holds 50% or more of the sponsor's company's votes or shares
• share a parent company with the sponsor, where they are controlled by the same company that controls the sponsor's company

A company that has not yet completed a full fiscal year may estimate or project their annual gross revenue and number of employees. In these cases, Health Canada will follow up once the sponsor's fiscal year-end date has passed to verify their small business status.

At any time, Health Canada may ask the sponsor for additional information in order to verify their small business status. Information may include:

• records that identify the number of persons employed for the previous fiscal year
• financial statements
• tax returns
• corporate or management organization charts
• other official documents issued or certified by a business registration authority

Publicly funded health care institutions

Fees will be waived for all drug submissions or applications filed by publicly funded health care institutions. For example, hospitals filing submissions for radiopharmaceutical diagnostic isotopes will not have to pay a fee.

A publicly funded institution is an institution that is funded by the Government of Canada or a provincial/territorial government and is either:

• licensed, approved or designated by a province/territory in accordance with the laws of the jurisdiction to provide care or treatment to persons or animals suffering from any form of disease or illness or
• owned or operated by the Government of Canada or a province/territory and provides health services

Government organizations

Fees will be waived for submissions or applications filed by a branch or agency of the Government of Canada or of a province/territory. For example, the Department of National Defence or the Public Health Agency of Canada will not have to pay fees.

Organizations sponsoring drugs under Canada's Access to Medicines Regime

Fees will be automatically deferred for sponsors that file a submission or application at the same time as an application to sell a drug under section C.07.003 of the Food and Drug Regulations. Fees are deferred until a notice of compliance (NoC) and/or drug identification number (DIN) is issued.

Fees will be waived if sponsors subsequently receive an authorization under section 21.04 of the Patent Act.

For information on how to apply for this type of mitigation, please refer to the Guidance on the application process for drugs for export to developing and least developed countries.

Urgent public health need

Fees may be waived for products on the list of drugs for an urgent public health need in accordance with the Access to Drugs in Exceptional Circumstances Regulations.

Submissions or applications are eligible to be reviewed for free if:

• the drug has the same medicinal ingredient, strength and route of administration, and is in a comparable dosage form to a drug on the list and
• a DIN or NoC has not previously been issued for the product

The full fee will be charged if additional dosage forms, strengths or routes of administration are included in the submission.

Interim order for the importation, sale and advertising of COVID-19 drugs

Pre-market evaluation fees will be remitted for submissions filed under the Food and Drug Regulations seeking approval for a COVID-19 drug. However, the application must have been previously filed under the interim order for the same drug, and not have been previously filed under the Food and Drug Regulations.

Once a drug receives an NOC, drug right to sell fees will apply.

COVID-19 drug submissions filed under the Regulations for which no interim order application was previously filed will be subject to fees.

Small business mitigation is available on all applicable fees for COVID-19 drug submissions.