ARCHIVED — Fees in Respect of Drugs and Medical Devices Regulations

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Vol. 144, No. 46 — November 13, 2010

Statutory authority

Financial Administration Act

Sponsoring department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issue: The current user fees for regulatory activities related to human drugs and medical devices have not been updated since their initial implementation starting in 1995, and no longer reflect the costs of delivering services. This has resulted in increasing funding pressures on Health Canada and impacted its ability to meet internationally recognized performance standards.

Description: The proposed Regulations formalize the objectives of Health Canada’s User Fees Proposal, which are based on updating fee amounts, modernizing fee mitigation measures and providing an annual adjustment of fees. The proposed Regulations would also consolidate various existing user fees regulations and provide the following key elements: adjusting fees annually, establishing fees for a regulatory activity, stipulating the amount in a schedule or provision, establishing timing and allotment of fees payable, and providing fee mitigation measures.

Cost-benefit statement: The cost-benefit analysis supports the regulatory proposal to increase fees for services in the amount of $66.4 million. These fees will help to cover increased cost to Government for evaluating the safety and efficacy of human drugs and medical devices, as well as monitoring and enforcing compliance of the relevant regulations. The overall net present value (i.e. the benefit) of this regulatory proposal would be $639.9 million over 10 years.

Business and consumer impacts: The updated fees are largely offset by benefits to consumers and businesses that accrue through the earlier entry of new drugs and medical devices as a result of Health Canada’s meeting its service standards. In addition, the proposed Regulations provide fee mitigating measures to address undesired impacts to businesses with small revenue streams.

Domestic and international coordination and cooperation: Consultations have been conducted with domestic and international stakeholders. Although foreign companies are required to pay fees for the sale of human drugs and medical devices in Canada, there is no expected conflict with international trade agreements or obligations.

Performance measurement and evaluation plan: Health Canada has developed a Performance Measurement and Evaluation Plan (PMEP), describing the commitments to planning, monitoring, evaluating, and reporting on results of the proposed Regulations and overall cost recovery initiative. Also as part of the User Fees Act, Health Canada will report annually to Parliament on associated cost, revenues and performance. Where the Department is not able to meet performance standards associated with cost recoverable activities, then, as per the User Fees Act, financial penalties will result.

Issue

The Food and Drugs Act and Controlled Drugs and Substances Act and their regulations set out regulatory requirements that industry must satisfy in order to market a human drug or medical device in Canada. Health Canada is the federal authority responsible for regulating these products both pre- and post-market.

In the early 90s, Health Canada was given the authority under the Financial Administration Act to charge industry user fees in order to recover some of the costs related to service delivery for human drugs. In the late 90s, this authority was extended to medical devices. At that time, the cost of service delivery was approximately $80 million annually and revenues from fees were $40 million.

The cost of service delivery has increased substantially since that time (up to $172.1 million for 2009–2010) due to increasing volume and complexity of submissions and marketed products, along with inflation and other costs of doing business. In the absence of updated user fees, it is projected that, by the year 2011–2012, revenues from user fees will cover only 23% of cost, as compared to 50% when user fees were first introduced.

Insufficient funding has led to many impacts on Health Canada’s ability to meet internationally recognized performance standards. Growing costs and outdated fees have led to increasing backlogs in the review of product submissions, surveillance of marketed products, and inspections. In turn, such backlogs impede timely access to therapies needed by Canadians, as well as impact industry with respect to making timely marketing and other investment decisions.

Further, the reports of the Office of the Auditor General of Canada (OAG) of 2004 and 2006 titled, respectively, the Regulation of Medical Devices and Allocating Funds to Regulatory Programs have noted the need for sufficient and stable funding and have recommended that Health Canada update its cost recovery regime in order to provide appropriate levels of service delivery.

Objectives

The outdated cost recovery framework has placed an increasing and unsustainable funding pressure on Health Canada. To mitigate some of this pressure, the Department has relied on public funds, which now cover an increasing and inappropriate share of service delivery cost, given the direct benefits industry derives from Health Canada’s regulatory services.

In 2005–6, Health Canada determined the full cost of delivering regulatory services for its human drugs and medical devices programs, associated service standards and required revisions to existing fees. Then, in 2010, Health Canada published a user fee proposal, titled “User Fees and Service Standards for Human Drugs and Medical Devices Program” (User Fees Proposal), which was approved in full by Parliament in May 2010.

Specifically, the User Fees Proposal provides the updated fee amounts, fee mitigation measures, and an annual adjustment of fees. The objective of the proposed Regulations would be to formalize these elements of the User Fees Proposal. In particular, updated fees and current levels of public funding would provide sufficient funding for Health Canada to meet service standards and support access to drugs and medical devices to Canadians in a timely manner.

The proposed Regulations also respond to the OAG recommendations to update fees to reflect costs. In addition to meeting the requirements of the User Fees Act (2004), this proposal was developed in accordance with the Treasury Board Secretariat’s Policy on Service Standards for External Fees, and with Health Canada’s Policy and Guidelines on External Charging.

Description

Overview of regulatory proposal

Overall, the proposed Regulations entitled Fees in Respect of Drugs and Medical Devices Regulations would update fees and consolidate various existing user fees regulations. Key elements of the regulatory proposal include the following: adjusting fees annually, establishing fees for a regulatory activity, stipulating the amount in a schedule or provision, establishing timing and allotment of fees payable, and providing fee mitigation measures.

Specifically, the regulatory proposal would establish updated fees for human drugs and medical devices as presented in the User Fees Proposal and approved by Parliament, and these would be payable by industry for pre- and some post-market activities related to the

  • evaluation of a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission; processing of an application for a drug establishment licence or the annual review of a licence; evaluation of an application for a drug identification number; and the right for a holder of a drug identification number to sell a drug under the Food and Drug Regulations;
  • evaluation of an application for a dealer’s licence for a controlled drug under Part G of the Food and Drug Regulations or a narcotic under the Narcotic Control Regulations; and
  • evaluation of an application for a medical device licence, processing of an application for a medical device establishment licence or the annual review of a licence and the right for the holder of a medical device licence to sell a medical device under the Medical Devices Regulations.

Exemption

There is no cost recovery regime in place for natural health products (NHPs). The proposed Regulations would not apply to NHPs, thus retaining the status quo.

The proposed Regulations would not apply to drugs proposed for veterinary use only and the existing Veterinary Drug Evaluation Fees Regulations would continue to apply. The existing Authority to Sell Drugs Fees Regulations would also continue to apply, but only to veterinary drugs. Similar amendments would be made to continue the Licensed Dealers for Controlled Drugs and Narcotics Fees Regulations and Establishment Licensing Fees Regulations, as they apply to veterinary drugs.

The regulatory proposal would exempt publicly funded health care facilities or any branch or agency of federal and provincial governments from fees for drug and medical device establishment licences and dealer’s licences. Additionally, persons or organizations solely conducting scientific investigations would also be excluded from fees associated with dealer’s licences.

As part of Health Canada’s effort to consolidate the Regulations, the Drug Evaluation Fees Regulations and Fees in Respect of Medical Devices Regulations would no longer be applicable and therefore would be repealed.

Fee mitigation measures

Health Canada recognizes that, in certain situations, fees might result in an undue burden on certain groups or individual fee payers. Health Canada’s approach to fee mitigation has always focussed on facilitating the availability of products to help Canadians maintain and improve their health, and encouraging innovation and access to new products. The proposed Regulations would formalize Parliament’s approval of fee mitigation measures, providing applicants opportunities to seek a remission and a deferral of payment.

Remissions would be available to applicants with small revenue streams, such that the applicable fees exceed a specified percentage of actual gross revenues, determined during a verification period from the sales in Canada for that human drug or medical device. To be eligible for a remission, an applicant would have to provide information to support anticipated revenues. If an applicant failed to submit or complete a request to determine the fee remission, the fees would be payable immediately as per the proposed Regulations. Furthermore, upon audit, differences between projected and actual amounts would be adjusted accordingly.

In some cases, companies in their first year of business would be able to seek a deferral of fee payment of one or two years depending on the application submitted. The applicant would be required to submit information certifying that the company has not yet completed its first fiscal year. If inaccurate information were to be provided, then the deferral would not be applicable and fees would be payable in accordance with the proposed Regulations.

The proposed Regulations would also provide for the deferral and remission of fees for the evaluation of submissions and applications for human drug and medical device that are intended to be sold for international humanitarian purposes pursuant to the 2003 World Trade Organization’s General Council Decision.

The regulatory proposal would also provide mitigation measures related to drug establishment licensing fees for the medical gas industry, with respect to fees for packaging/labelling activities in the form of trans-filling. Specifically, if a medical gas company conducts the activity of packaging/labelling of a medical gas at more than one building, the fee payable would be calculated as if the activity was conducted at a single building. Fees for all other activities related to the medical gas would continue to be calculated for each building at which the activity is conducted and in accordance with the proposed Regulations.

Annual adjustment of fees

The proposed Regulations would require an annual adjustment of all fees by 2% as presented in the User Fees Proposal, and as approved by Parliament. For purposes of transparency, a notification of intent setting out the revised fees would be published in the Canada Gazette, Part I, beginning on April 1, 2012.

Proposed consequential amendments

The proposed Regulations require consequential amendments to the provisions in the Food and Drug Regulations and Medical Devices Regulations related to the expiration of establishment licences. Health Canada issues establishment licenses allowing establishments to conduct otherwise prohibited activities such as fabricating, packaging/labelling, importing, distributing and wholesaling drugs and importing and selling medical devices. Under the current Regulations, each drug or medical device establishment licence expires on December 31, no matter when in the year the licence was applied for or issued. Thus, in order to continue conducting the otherwise prohibited activities following expiry on December 31 each year, an establishment must have applied for and have been issued a new establishment licence.

The proposed Regulations would eliminate the scenario described above by removing the expiry of establishment licences on December 31, while maintaining a requirement for annual review of the establishment licence. The proposed elimination of the expiry date would allow all establishment licences to continue, once issued, unless they are cancelled by Health Canada or the licence holder fails to file an application for annual review prior to April 1. This latter requirement would allow Health Canada to conduct the annual review to verify that establishments are in compliance with the applicable establishment licence regulations.

Under the proposed Regulations, suspended establishment licences must be reinstated prior to an application for annual review. If the suspended licence was not reinstated prior to April 1 in a given year, the licence would be cancelled and the establishment would have to apply anew for a drug or medical device establishment licence.

Coming into force

All applications, submissions or supplements filed before the coming into force of these proposed Regulations would be governed by the existing fees regulations under which they were filed. The proposed updated fees would apply in all other cases. These proposed Regulations would come into force on the day on which they are registered.

Regulatory and non-regulatory options considered

The following options were considered:

Status quo

Health Canada considered continuing the existing cost recovery framework, representing user fees established in the 1990s and managing funding pressures through limited tax appropriations. However, this option would not establish good financial administration related to external charging or policy, with user fees not representative of costs, and increasing funding pressures. Without updated fees and given the rapidly increasing cost of service delivery, the impact not only affects Health Canada’s ability to effectively meet internationally recognized performance standards, but further impacts the availability of needed therapies on the market. In addition, this option would not address the OAG concerns regarding the need for proper funding while regulatory demands on the Department increase.

Phased fees

Consideration was given to phasing in fees by specific product lines and services over a period of time. This option would present timing issues whereby an applicant could circumvent the process and increase the workload of an already overburdened system. As well, consideration was given to delaying implementation to be in line with billing cycles and appropriate levels of appropriations for applications. However, it was determined that all fees should be changed and implemented at the same time given they were consulted upon in 2007, so that the system could adapt and move forward.

Updated user fees

With this option, an updated comprehensive regulatory framework for user fees would be established to reflect current services and their costs. In addition, the framework would include mitigating measures to alleviate undesired impacts of fees, particularly on small business, thus it would encourage innovation and access to products. This option would be consistent with the OAG recommendations and in line with the initial introduction of user fees for human drugs and medical devices, whereby the fee payer shares an appropriate portion of cost for service delivery. This is the preferred option.

Benefits and costs

The cost-benefit statement below represents an evaluation based on a 10-year period. Although the amounts were increased by 2% starting in 2012–2013 to account for inflation, and for consistency with cost-benefit analysis principles, the real values were used for the analysis. To derive costs and benefits in present value (PV) terms, amounts were discounted by 8% as recommended by the Treasury Board Secretariat in its Canadian Cost-Benefit Analysis Guide: Regulatory Proposals (2007).

The following cost-benefit analysis supports the regulatory proposal to increase industry user fees for the introduction of medical devices and human drugs. These fees will help to cover increased cost to Government for maintaining service standards in the evaluation of the safety and efficacy of human drugs and medical devices, as well as monitoring and enforcing compliance of the relevant Regulations. Overall, the regulatory proposal would result in a net present value (NPV) of $639.9 million over 10 years.

Cost-benefit statement

Base Year 2011–2012

Final Year 2020–2021

Total
(PV)

Average Annual

A. Quantified impacts $

Benefits

$

$

$

$

Benefits to consumers, patients, health insurers and taxpayers

Potential savings as a result of speedier regulatory decision on generics

Consumers, patients, public and private health plan insurers

$11.5M

$11.5M

$83.3M

$11.5M

Amount saved as a result of the proposed Regulations

Canadian taxpayers

$66.4M

$66.4M

$481.2M

$66.4M

Benefits to industry — Human drugs

Reduction in waiting time with an assigned monetary value for New Active Substances (NAS) review

Industry — Innovators

$8.7M

$8.7M

$63.1M

$8.7M

Potential early entry of an approved New Active Substance (NAS)

Industry — Innovators

$38.1M

$38.1M

$276.1M

$38.1M

Reduction in waiting time with an assigned monetary value for ANDS1 — Comparative Studies and Chemistry and Manufacturing type

Industry — Generics

$25.1M

$25.1M

$181.9M

$25.1M

Potential early entry of an approved ANDS — Comparative Studies and Chemistry and Manufacturing type

Industry — Generics

$11.5M

$11.5M

$83.3M

$11.5M

Total

Human drugs

$83.4M

$83.4M

$604.4M

$83.4M

Benefits to industry — Medical devices

Reduction in the waiting time with an assigned monetary value for the medical device sector

Industry

$54.5M

$54.4M

$395.0

$54.4M

Total benefits

$215.8M

$215.8M

$1,563.8M

$215.8M

Costs

$

$

$

$

Proposed fee increase

Consumers, patients, industry, public and private health plan insurers

$66.4M

$66.4M

$481.2M

$66.4M

Accelerated loss in revenue as a result of earlier entry of generics

Industry — Innovators

$23.0M

$23.0M

$166.7M

$23.0M

Potential increase in expenditure as a result of early entry of NAS

Consumers, patients, public and private health plan insurers

$38.1M

$38.1M

$276.1M

$38.1M

Total costs

$127.5M

$127.5M

$924.0M

$127.5M

Net present value

$639.9M

B. Quantified impacts in non-$

Positive impacts

1. The benefit of an early entry of a NAS human drug may provide better health outcomes to patients, which may in turn reduce other health care cost. This would offset part of the expenditure incurred by patient and public and private health plan insurers. It is anticipated that there may be a slight adjustment required by public health plans, as well as private insurers. However, the potential impact may be discounted by early access to important and new therapies available to Canadians.

2. Industry can expect Health Canada to meet established performance standards with additional resources for the cost-recovered activities. This excludes the NAS New Drug Submission and Comparative Studies and Chemistry and Manufacturing type of ANDSs. The improvement related to review times for all other types of human drugs submissions ranges between 1.11% for DIN D (Disinfectant) to 118.1% for DIN A (application) submissions.

3. The Regulatory proposal does not mean an automatic fee increase. For example, a Class IV — Licence Application (medical devices that contain human/animal tissue) is reduced from the current range of $12,790 to $14,490 to the proposed amount of $10,960. This is a significant fee reduction of about $1,830 to $3,530.

C. Qualitative impacts

1. According to Industry Canada, the medical devices industry in Canada has been changing its sources of imports; this change introduces an uncertainty that Health Canada must verify, which represents an additional cost.

2. If Health Canada is adequately funded, it can effectively maintain its regulatory oversight role. Regulatory approval from Health Canada is often cited by industry as part of the marketing strategy to promote a product or lend confidence when safety issues are a concern; this is particularly important to small- and medium-sized enterprises (SMEs).

3. A more timely process of post-market activities, such as those related to supplemental new drug submissions or supplemental abbreviated new drug submissions, should reduce information asymmetry for consumers, patients and health care professionals which can lead to improved health related decisions.

4. According to research conducted by the Government of Canada’s Policy Research Initiative, the monetary value of reductions in mortality risks (the dollar amount to reduce the risk of one death) in Canada is worth $6.5M. It can be argued that the proposal could more than pay for itself if it leads to post-market efforts that could moderately reduce the risk of mortality.

1 Abbreviated New Drug Submission — Generic application

Benefits

Benefits to consumers, patients and insurers

The present value (PV) benefits over a 10-year time period to consumers, patients, and public and private health plan insurers is estimated at $83.3 million. This amount represents a 50% reduction from the brand name price. In addition, the updated fee will result in a benefit to consumers, patients and public and private health plan insurers as human drugs and medical devices may enter the market sooner.

Benefits to Canadian taxpayers

Canadian taxpayers would save approximately $481.2 million in PV terms between fiscal years 2011–12 and 2020–21 if the proposed Regulations are implemented. This amount represents the total PV of the funding gap between the established service standards and current performance. If no additional funding is provided, then Canadian taxpayers must accept current performance and the consequences of not meeting the established service standards.

Benefits to industry — Human drugs

It is estimated that the total quantified PV benefits to the industry for innovative human drugs including generics is $604.4 million. Industry would benefit from more efficient performance standards as Health Canada would be adequately resourced to meet service standards. Specifically, for NAS, the assigned PV benefits for the reduction in waiting times are $63.1 million over a 10-year period.

For generics and their Comparative Studies and Chemistry and Manufacturing type of submission, the PV benefits would be $181.9 million between fiscal years 2011–12 and 2020–21.

Benefit to industry — Medical devices

The PV benefits for the medical devices industry are estimated to be $395.0 million over 10 years. This amount is calculated based on the turnover of the products within a year and the potential loss of sales calculated at an average daily rate, then multiplied by the average number of days that exceeded service for the various classes of devices.

It is estimated that the infusion of fees into the review process for pre-market assessments of human drugs and medical devices would result in meeting the service standards for review assessments.

These estimates are based on the assumption that there is a value attached to time for industry associated with the delay in regulatory review, regardless of the decision made by Health Canada. This is particularly important to start-ups and small businesses, which may not have the cash inflow.

Cost

Cost to consumers, patients and insurers

Based on the proposed fee increase, there is a PV cost to consumers, patients, and public and private health plan insurers in the amount of $481.2 million over a 10-year period. This calculation is based on the funding gap between established service standards and actual or current performance.

In addition, patients and public and private health plan insurers may incur a PV cost totalling $276.1 million as a result of early access to NAS human drugs on the market. However, the cost could be offset by the benefits of early access to the presumed improved health outcomes of these therapies. This cost represents an average which was derived from the difference in data collected from the Price, Medicines and Review Board and Industry Canada.

Cost to industry — Human drugs

The human drugs and medical devices industries would be expected to pay a total of $345.0 million and $136.2 million (PV) respectively for the processing of applications for marketing authorizations, issuance of establishment licences and annual authority to sell during the 10-year period. The amount would be reduced by any costs that are being passed to patients and their public or private health plan insurers.

The total PV cost of this regulatory proposal on innovative human drugs is $166.7 million. This is based on those generics which are not impacted by the Patented Medicines (Notice of Compliance) Regulations or data protection under the Food and Drug Regulations and which replace brand name product sales sooner as a result of more efficient regulatory process.

The complete cost-benefit analysis will be posted on Health Canada’s Web site.

Rationale

Overall, this regulatory proposal would update existing user fees and address current insufficient cost recovery of regulatory services. Revenues from updated fees will restore the public and private cost-sharing ratio and allow Health Canada to meet internationally recognized performance standards, in turn supporting timely access to human drugs and medical devices, thus benefiting consumers and industry.

It should also be noted that all comparable international regulators charge fees for comparable services and attempt to meet comparable service standards. Most countries have updated their user-fee levels since initial introduction, and many recover a larger percentage of the cost of services than what is proposed by Health Canada. Specifically comparing the cost-sharing levels, in 2005–6, Canada had a low regulatory cost-sharing level at approximately 28% for its human drug and medical device programs, while the cost-sharing levels of the United Kingdom and Australia were at 100%, the European Union at 70% and the United States at 50%.

Consultation

Health Canada undertook extensive stakeholder consultations of its proposed fees and service standards, established Independent Advisory Panels, and developed a User Fees Proposal which was approved by Parliament. The User Fees Proposal provides the basis of these proposed Regulations. Consultations were conducted in several stages using various means of communication and were consistent with the requirements under the User Fees Act.

In spring 2007, Health Canada held consultations on the proposed Cost Recovery Framework. A consultation document was posted on Health Canada’s Web site. The document explained how user fees and service standards were developed, and identified costs, revenues and international comparisons. More than 5 000 stakeholders, including present and potential fee payers, were advised of consultations and invited to provide written answers to the online questions. A Business Impact Test (BIT) survey was included as part of the consultation document.

The BIT survey was used to identify unintended and unexpected impacts on businesses. It was reported by a majority of the respondents that the proposed fees would have some negative impact on their business, particularly in regard to the proposed introduction of fees for product lines not previously subject to cost recovery. However, many respondents agreed that updated cost recovery fees were needed and that revenues should directly fund regulatory services and reduce review times.

Participants in the consultation included health product companies; industry associations (including pharmaceuticals, radiopharmaceuticals, biologics and genetic therapies, medical devices and natural health products); consumers and public interest groups; patient groups; academia; and health professional associations.

Nearly 200 responses to the BIT were analyzed, as were a similar number of written responses to a series of questions related to the proposal.

Concurrently, key stakeholders were invited to participate in face-to-face discussions. Eighteen of these meetings were held, allowing stakeholders to discuss specific issues of concern, flesh out solutions, and prepare written responses to the consultation document. The bilateral and small group meetings were followed by a multi-stakeholder meeting (an expanded Branch Advisory Committee on Management) that brought more than 20 diverse groups together to share their comments on the proposed framework. Following the consultation activities, a Stakeholder Consultation Report was posted on Health Canada’s Web site at the following address: www.hc-sc.gc.ca/dhp-mps/finance/costs-couts/consultation/report_rapport-eng.php.

Official notice of fee proposal

As required under subsection 4(1) of the User Fees Act, an official notice of the fee proposal (Cost Recovery Framework: Official Notice of Fee Proposal for Human Drugs and Medical Devices) was published in July 2007. Eleven drug and eight med-ical device stakeholders registered official complaints that resulted in the establishment of Independent Advisory Panels (one on human drugs, the other on medical devices) as required by the User Fees Act.

Overall, the Panels found that the proposed user fees were based on a thorough costing methodology and were internationally comparable. The Panels remarked that stable funding must be secured by Health Canada in order to meet its internationally recognized performance standards. Recommendations made by the Panels were taken into consideration and several led to changes in the User Fees Proposal.

Since July 2007, status updates on Health Canada’s cost recovery initiative have been provided to industry, consumer and patient associations. In addition, discussions on Health Canada’s position regarding the recommendations made by the Panels have taken place with key industry associations and patient groups.

Complaints were received from individual companies as well as industry associations, but no non-fee payers. Overall, the majority of stakeholders impacted by the proposal supported up-dating user fees provided that the fees were spent directly on service delivery and that performance targets would be met.

Further, after the publication of the Official Notice and the receipt of its subsequent feedback, fees for Good Clinical Practices applications and fee differential for biologic drugs were removed from the Proposal.

Parliamentary tabling of User Fees Proposal

As required under subsection 4(2) of the User Fees Act, Health Canada tabled in Parliament Health Canada’s Proposal to Parliament for User Fees and Service Standards for Human Drugs and Medical Devices Programs. The Senate Standing Committee on Social Affairs, Science and Technology reviewed the User Fees Proposal and recommended that it be approved. During the Committee’s review, key industry stakeholders were invited as witnesses.

With the tabling of a User Fees Proposal in Parliament, several additional stakeholder engagement efforts were conducted in order to share information regarding the Proposal and answer questions.

Outreach efforts have continued since the User Fees Proposal was approved by Parliament.

Stakeholder positions

Most major industry associations have been supportive of the proposed fee changes provided that performance standards are met, though some industry associations have raised concerns on some of the fees. In particular, the industry association representing the medical devices sector has raised concerns regarding the changes in fees.

Major health care professional associations have been supportive of fee changes, as well as most patients and consumer groups. However, some public advocacy groups along with some academics have raised concerns about user fees for regulatory activities in general.

Implementation, enforcement and service standards

Communication / outreach strategy

As part of the implementation of the proposed Regulations, a communication strategy would involve notices to stakeholders regarding updated fees, as well as development of guidance documents in consultation with stakeholders, and posted on Health Canada’s Web site. Revised fees would be published in the Canada Gazette, Part I, reflecting the annual adjustment of 2%.

Human resources

A key component to the success of the cost recovery initiative supported by the proposed Regulations is the ability to staff a number of new positions, predominately within scientific and professional categories. Health Canada is currently planning to hire staff to ensure successful implementation of the updated fees and the ability to meet performance targets. Further, Health Canada is planning to develop training programs for new employees, as well as strategies to address retention of experienced staff.

Information technology systems

Health Canada’s information technology (IT) system has been in place to support service standards since 1995. IT changes necessary to support the regulatory proposal would be made, and upgrading tracking systems to clearly demonstrate revenues collected and allocated to cost recovery activities are under way.

Enforcement

If an applicant fails to pay a fee, then that fee payable would be a debt owing to the Crown which would be collected as per standard practice.

Service standards

With respect to service standards, Health Canada has consulted both fee paying and non-fee paying stakeholders, as required by the User Fees Act. For each fee, Health Canada has identified a service standard that reflects the level of service that can be expected. Existing service standards would be maintained with the updated fees coming into force, as presented during the consultations, and the User Fees Proposal. Service standards would no longer be the expected level of service, but will become a service commitment with recourse for underperformance, as per the User Fees Act.

Performance measurement and evaluation

Health Canada has developed a Performance Measurement and Evaluation Plan (PMEP), describing the commitments to planning, monitoring, evaluating, and reporting on results of the proposed Regulations and overall cost recovery initiative. Specifically, the PMEP is based on a logic model that illustrates the flow from resources and activities to expected results, as well as indicators measuring changes in outputs and impacts of the proposed Regulations.

The logic model

The activities identified in the logic model are the regulatory services provided by Health Canada for which a user fee is charged. Through the activities, the products and services (outputs) used to implement the proposed Regulations would be produced and delivered to the affected stakeholders, both industry and Canadians. The outputs include, for example, drugs and medical devices market authorization decisions and the issuance of establishment licences.

The short-term outcomes focus on the objectives of the proposed cost recovery regulatory amendments as implemented through the human drugs and medical devices programs.

The intermediate and long-term outcomes focus on supporting the timely access to safe and high quality human drugs and medical devices by Canadians, better industry compliance, and improved consumer health outcomes. These outcomes are part of the overall program outcomes for human drugs and medical devices programs.

The short-term outcomes contribute to the achievement of the overall program outcomes identified in the intermediate and long-term outcomes. All outcomes would also contribute to Health Canada’s strategic objective that ultimately leads to the improved health status of Canadians.

Indicators used to measure performance

The proposed indicators used to measure performance are derived from the logic model and are in support of Health Canada’s 2011–2012 Program Activity Architecture — Performance Measurement Framework.

Reporting and improvements on performance

The service standards are published in the User Fees Proposal and Health Canada will continue to report on performance against standards annually. Over the next two years, Health Canada will conduct an internal assessment and will introduce additional measures to extend its information and performance reporting capabilities beyond the performance standards defined in the User Fees Proposal.

Health Canada is committed to service improvements and will discuss mechanisms to improve service delivery and regulatory performance against service standards as part of the Departmental Performance Report. As required under subsection 4(2), and sections 5.1 and 7 of the User Fees Act, the Department would also be required to report annually to Parliament on associated costs, revenues and performance. Where the Department does not meet performance in a particular fiscal year in respect of a user fee by a percentage greater than de 10%, the user fee will be reduced by a percentage equivalent to the unachieved performance, to a maximum of 50% of the user fee. The reduced user fee applies from the day on which the annual report for the fiscal year is tabled under subsection 7(1) of the User Fees Act until the day on which the next annual report is tabled.

Also in accordance with the Treasury Board Secretariat’s Policy on Service Standards for External Fees, Health Canada must report to Parliament annually on performance against service standards.

Finally, Health Canada will review the fees and cost of services every three years and may propose new or amended fees to reflect the results of these reviews.

Evaluation of proposed regulatory activities

Health Canada has developed a Departmental Five-Year Evaluation Plan (2010–11 to 2014–15). The evaluation of this regulatory initiative would be rolled up to the human drugs and medical devices programs’ evaluations in the next five-year cycle for 2015–16 to 2020–21. Reporting on the outcomes of the proposed Regulations would be included in these evaluations.

The user fee regime specific to human drugs and medical devices would be reviewed every three years and would be adjusted as appropriate. Work is currently being undertaken in support of the summative evaluations of both the human drugs and the medical devices programs. These evaluations would be conducted on the programs as a whole, which would include all program activities, and would not be limited to details around cost-recoverable activities. As summative evaluations they would assess the relevance, design and delivery as well as the intended results, and efficiency of the programs. It is anticipated that the evaluation report for the human drugs program would be available in 2012 and for the medical devices program in 2013.

Moreover, the PMEP only covers those activities and outputs associated with user fees under the proposed Regulations. However, the proposed Regulations contribute to and are part of a broader set of programs (i.e. human drugs activities, biologics, and medical devices). These programs already have or plan to include program evaluations. The user fee activities, including the outputs and the outcomes to which they contribute would be reported in future program evaluations.

To obtain a copy of the PMEP please make a request to the contact below.

Contact

Kendal Weber
Director General
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Address Locator: 2004A, Graham Spry Building
250 Lanark Avenue, 4th Floor
Ottawa, Ontario
K1A 0K9
Fax: 613-954-9981
Email: cri_irc_consultations@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 19(1) (see footnote a) and section 19.1 (see footnote b) of the Financial Administration Act (see footnote c), and, considering that it is otherwise in the public interest, subsection 23(2.1) (see footnote d) of that Act, proposes to make the annexed Fees in Respect of Drugs and Medical Devices Regulations.

Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Kendal Weber, Director General, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Health Canada, Address Locator: 2004A, Graham Spry Building, 250 Lanark Avenue, 4th Floor, Ottawa, Ontario K1A 0K9 (fax: 613-954-9981; email: cri_irc_consultations@hc-sc.gc.ca).

Ottawa, November 4, 2010

JURICA ČAPKUN
Assistant Clerk of the Privy Council

FEES IN RESPECT OF DRUGS AND MEDICAL DEVICES REGULATIONS

PART 1

GENERAL

DEFINITION

Definition of “Minister”

1. In these Regulations, “Minister” has the same meaning as in section 2 of the Food and Drugs Act.

PURPOSE

Purpose

2. The purpose of these Regulations is to prescribe the fees to be paid for

(a) the examination of a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission referred to in sections C.08.002, C.08.002.1 or C.08.003 of the Food and Drug Regulations, an application for an establishment licence under those Regulations or an application for a drug identification number under section C.01.014.1 of those Regulations;

(b) the examination of an application for a dealer’s licence under Part G of the Food and Drug Regulations or under the Narcotic Control Regulations;

(c) the right to sell a drug under the Food and Drug Regulations; and

(d) the examination of an application for a medical device licence, the right to sell a medical device or the examination of an application for an establishment licence under the Medical Devices Regulations.

APPLICATION

Non-application

3. These Regulations do not apply in respect of

(a) a drug that is proposed for veterinary use only; and

(b) a drug that is a natural health product.

ANNUAL ADJUSTMENT OF FEES

Adjustment of fees

4. Every fee set out in these Regulations is to be increased annually by 2%, rounded upwards to the nearest dollar, beginning on April 1, 2012.

PART 2

DRUGS

DIVISION 1

FEES FOR DRUG SUBMISSION EXAMINATION

Interpretation

Definitions

5. (1) The following definitions apply in this Division.

“actual gross revenue”
« recettes brutes réelles »

“actual gross revenue” means the amount earned by the person referred to in section 6 during the fee verification period from the sales in Canada of the drug that is the subject of a submission, a supplement to a submission or an application referred to in section 6.

“anticipated gross revenue”
« recettes brutes prévues »

“anticipated gross revenue” means the amount that the person referred to in section 6 expects to earn during the fee verification period from the sales in Canada of the drug that is the subject of a submission, a supplement to a submission or an application referred to in section 6.

“fee verification period”
« période de vérification du prix à payer »

“fee verification period”, in respect of a drug that is the subject of a submission, a supplement to a submission or an application referred to in section 6, means the period beginning on the day on which the drug is first sold in Canada and ending three years after that day.

Words and expressions

(2) Unless the context otherwise requires, all other words and expressions used in this Division have the meanings assigned to them by the Food and Drug Regulations.

Fees

Fee for examination

6. Subject to sections 11 to 14, the fee that is payable by a person who files for examination on a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission referred to in sections C.08.002, C.08.002.1 or C.08.003 of the Food and Drug Regulations or a person who files an application for a drug identification number under section C.01.014.1 of those Regulations is, in respect of the submission class set out in column 1 of Schedule 1 and described in column 2, the fee set out in column 3.

Timing of payment

Timing of payment — $10,000 or less

7. (1) If the fee referred to in section 6 is $10,000 or less, it is payable at the time that the submission, supplement or application is filed.

Timing of payment — more than $10,000

(2) If the fee referred to in section 6 is more than $10,000,

(a) 10% of the fee is payable on receipt of a notice from the Minister stating that the submission, supplement or application has been found to be incomplete following a preliminary examination;

(b) 75% of the fee is payable on receipt of a notice from the Minister stating that the submission, supplement or application has been found to be complete following a preliminary examination and has been accepted for further examination; and

(c) 25% of the fee is payable on receipt of a notice from the Minister stating that the examination of the submission, supplement or application has been completed.

Remission — not accepted for examination

8. If the total amount of the fee has been paid at the time of filing in accordance with subsection 7(1) and the person referred to in section 6 receives a notice from the Minister stating that the submission, supplement or application has not been accepted for further examination, remission is granted of the amount paid less 10%, which the Minister must repay to that person.

Deferred payment

9. (1) If the person referred to in section 6 has not completed their first full fiscal year on the day on which they file the submission, supplement or application, the Minister must grant the person a two-year deferral of payment from the day of that filing upon receiving a statement signed by the individual responsible for the person’s financial affairs specifying the commencement date of that fiscal year. At the end of the two-year period the person must pay all of the applicable amounts payable in accordance with section 7.

Inaccurate statement

(2) If the Minister determines, on the basis of any information available to the Minister, that a statement provided under subsection (1) is inaccurate, the Minister must notify the person that the payment cannot be deferred and is payable in accordance with section 7.

Deferred payment — notice of compliance

10. If the person referred to in section 6 simultaneously submits the submission, supplement or application and an application for authorization under section C.07.003 of the Food and Drug Regulations, the payment of the fee is deferred until the issuance of a notice of compliance under section C.08.004 of those Regulations or the issuance of a document setting out the drug identification number assigned for the drug under section C.01.014.2 of those Regulations.

Remission

Remission — anticipated gross revenue

11. (1) Remission is granted of the amount by which the fee payable under section 6 exceeds 10% of the actual gross revenue of a person referred to in section 6 if

(a) the person provides

(i) a statement signed by the individual responsible for the person’s financial affairs indicating the person’s anticipated gross revenue and certifying that the fee payable under section 6 is greater than an amount equal to 10% of that anticipated gross revenue,

(ii) information establishing that the fee payable under section 6 is greater than an amount equal to 10% of the person’s anticipated gross revenue, and

(iii) the amount of $500 for processing the remission; and

(b) on the basis of the information provided under paragraph (a) and any other information available to the Minister, the Minister concludes that the fee payable under section 6 will be greater than an amount equal to 10% of the person’s actual gross revenue.

Amounts payable

(2) The fee is then payable as follows:

(a) an amount equal to 10% of the person’s anticipated gross revenue is payable at the time and in the manner set out in section 7; and

(b) the amount, if any, by which the lesser of the fee payable under section 6 and 10% of the person’s actual gross revenue exceeds the amount paid under paragraph (a) is payable 60 days after the day on which the fee verification period ends.

Sales records

(3) Within 60 days after the end of the fee verification period, the person must provide the Minister with sales records in regard to the sales of the drug in Canada during the fee verification period, prepared in accordance with generally accepted accounting principles and certified by the individual responsible for the person’s financial affairs.

Omission

(4) If, within 60 days after the end of the fee verification period, the person has not provided the Minister with the records referred to in subsection (3), the difference between the fee payable under section 6 and the amount already paid under paragraph (2)(a) is immediately payable.

Remission — actual gross revenue

12. If the amount paid under paragraph 11(2)(a) is greater than 10% of the actual gross revenue of the person referred to in section 6, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the person.

Audited sales records

13. (1) If the Minister determines, on the basis of any information available to the Minister, that the records provided in accordance with subsection 11(3) are not adequate to determine the actual gross revenue of the person referred to in section 6, the Minister may require the person to provide sales records that have been audited by a qualified independent auditor and those records are to be used for the purpose of determining the fee payable or the amount of the remission.

Omission

(2) If, within 60 days after the day of the request for audited financial records, the person has not provided them to the Minister, the difference between the fee payable under section 6 and the amount already paid under paragraph 11(2)(a) is immediately payable.

Difference payable

(3) If the audited sales records referred to in subsection (1) establish that the amount paid under paragraph 11(2)(a) is less than 10% of the person’s actual gross revenue, the amount by which the lesser of the fee payable under section 6 and 10% of the person’s actual gross revenue exceeds the amount paid is immediately payable.

Difference remitted

(4) If the audited sales records referred to in subsection (1) establish that the amount paid under paragraph 11(2)(a) is greater than 10% of the person’s actual gross revenue, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the person.

Remission

14. Remission is granted to the person referred to in section 6 of the amount of the fee referred to in that section in respect of a drug if the manufacturer has received an authorization under section 21.04 of the Patent Act.

DIVISION 2

FEES FOR THE EXAMINATION OF AN APPLICATION FOR A DRUG ESTABLISHMENT LICENCE

Interpretation

Definitions

15. (1) The following definitions apply in this Division.

“activity”
« activité »

“activity” means an activity set out in Table I to section C.01A.008 of the Food and Drug Regulations.

“category”
« catégorie »

“category” means a category of drugs set out in Table II to section C.01A.008 of the Food and Drug Regulations.

“drug”
« drogue »

“drug” has the same meaning as in subsection C.01A.001(2) of the Food and Drug Regulations.

“establishment licence”
« licence d’établissement »

“establishment licence” means a licence issued under section C.01A.008 of the Food and Drug Regulations.

“health care facility”
« établissement de santé »

“health care facility” means a facility that provides diagnostic or therapeutic services to patients. It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities.

Words and expressions

(2) Unless the context otherwise requires, all other words and expressions used in this Division have the meanings assigned to them by the Food and Drugs Act or the Food and Drug Regulations.

Application

Non-application

16. This Division does not apply to any publicly funded health care facility or any branch or agency of the Government of Canada or of the government of a province.

Fee

Fee payable

17. (1) The fee that is payable by the applicant for the examination of an application for an establishment licence or for the annual review of an establishment licence is the sum of the applicable fees referred to in sections 18 to 24 and the fee that is payable by the applicant for the examination of an application for the amendment of an establishment licence is the sum of the fees referred to in sections 26 and 27.

Remission

(2) If the fee is greater than an amount equal to 1% of the applicant’s actual gross revenue from activities conducted under an establishment licence during the previous calendar year, remission is granted of the difference between those amounts if the applicant provides the statement referred to in subsection (5).

Timing of payment

(3) Subject to subsection (4), the fee is payable at the time the applicant submits an application for an establishment licence or for the annual review of an establishment licence under section C.01A.005 or C.01A.009 of the Food and Drug Regulations or an application for the amendment of an establishment licence under section C.01A.006 of those Regulations.

First year of activities

(4) If the applicant has not completed their first calendar year of conducting activities under the establishment licence, the payment of the fee is deferred by one year.

Statement

(5) If an applicant is eligible for a remission under subsection (2), the applicant must provide with their application a statement certified by the individual responsible for the applicant’s financial affairs that sets out the applicant’s actual gross revenue referred to in subsection (2).

Reinstatement

(6) Every provision in this Division that applies to an application for an establishment licence also applies to the reinstatement of an establishment licence by the Minister under section C.01A.018 of the Food and Drug Regulations.

Licence authorizing fabrication

18. (1) For the examination of an application for an establishment licence for each building at which one or more activities, including fabricating drugs, referred to in the application are to be conducted, the fee that is payable is the basic fee, set out in item 1 of column 2 of Schedule 2, and any of the following fees that are applicable:

(a) if the licence is in respect of more than one category, for each additional category, the fee set out in item 2 of column 2 of Schedule 2;

(b) if the licence is in respect of more than one dosage form class, the applicable fee set out in item 3 of column 2 of Schedule 2;

(c) if the licence is in respect of sterile dosage forms, the fee set out in item 4 of column 2 of Schedule 2.

Importing

(2) Despite section 20, if the importing of drugs is authorized by the establishment licence at a building referred to in subsection (1), the fee referred to in paragraph 20(b) is also payable.

Licence authorizing packaging/ labelling

19. (1) Subject to subsection (3), for the examination of an application for an establishment licence for each building at which one or more activities, including packaging/labelling drugs but not including fabricating drugs, referred to in the application are to be conducted, the fee that is payable is the basic fee, set out in item 1 of column 2 of Schedule 3, and any of the following fees that are applicable:

(a) if the licence is in respect of more than one category, for each additional category, the fee set out in item 2 of column 2 of Schedule 3;

(b) if the licence is in respect of more than one dosage form class, the applicable fee set out in item 3 of column 2 of Schedule 3.

Importing

(2) Despite section 20, if the importing of drugs is authorized by the establishment licence at a building referred to in subsection (1), the fee referred to in paragraph 20(b) is also payable.

Medical gas

(3) If the applicant for an establishment licence proposes to conduct activities only in regard to drugs in the dosage form class of medical gas at more than one building, the fee that is payable is the sum of the following fees:

(a) in regard to packaging/labelling, the basic fee set out in item 1 of column 2 of Schedule 3, as if only one building were authorized under the licence;

(b) in regard to all other activities, the fee that would be payable under subsection 17(1) if the application did not include packaging/labelling activities.

Licence authorizing importation

20. If one or more activities, including importing drugs but not including fabricating or packaging/ labelling drugs, are referred to in the application for an establishment licence, the fee that is payable for the examination of that application is

(a) for each building at which those activities are to be conducted, the basic fee, set out in item 1 of column 2 of Schedule 4, and any of the following fees that are applicable:

(i) if the licence is in respect of more than one category, for each additional category, the fee set out in item 2 of column 2 of Schedule 4,

(ii) if the licence is in respect of more than one dosage form class, the applicable fee set out in item 3 of column 2 of Schedule 4; and

(b) for each fabricator outside Canada of drugs that are imported, except if the importer provides a certificate from a Canadian inspector indicating that the fabricator’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4 of Part C of the Food and Drug Regulations, the sum of the following fees that are applicable:

(i) the fee set out in item 4 of column 2 of Schedule 4,

(ii) if the licence is in respect of more than one dosage form class, for each additional dosage form class, the fee set out in item 5 of column 2 of Schedule 4.

Licence authorizing distribution

21. For the examination of an application for an establishment licence for each building at which one or more activities, including distributing drugs as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations but not including fabricating, packaging/ labelling or importing drugs, referred to in the application are to be conducted, the fee that is payable is the basic fee, set out in item 1 of column 2 of Schedule 4, and any of the following fees that are applicable:

(a) if the licence is in respect of more than one category, for each additional category, the fee set out in item 2 of column 2 of Schedule 4;

(b) if the licence is in respect of more than one dosage form class, the applicable fee set out in item 3 of column 2 of Schedule 4.

Licence authorizing distribution or wholesaling

22. For the examination of an application for an establishment licence for each building at which one or more activities, including distributing drugs as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations or wholesaling drugs but not including fabricating, packaging/labelling or importing drugs or distributing drugs as a distributor referred to in paragraph C.01A.003(b) of those Regulations, referred to in the application are to be conducted, the fee that is payable is a basic fee of $3,870.

Licence authorizing testing

23. For the examination of an application for an establishment licence for each building at which only the testing of drugs is to be conducted the fee that is payable is a basic fee of $2,580.

Drug analysis fee

24. In addition to the fees referred to in sections 18 to 21, if the application for an establishment licence seeks to authorize the holder to fabricate, package/label, import or distribute drugs as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations, the fee that is payable is the highest fee set out in column 2 of Schedule 5 that corresponds to the drugs described in column 1 of that schedule

(a) in respect of which the licence is requested; and

(b) for which the holder has obtained a drug identification number, except in the case of an importer.

Audited sales records

25. (1) If the Minister determines that, on the basis of any information available to the Minister, the statement provided under subsection 17(5) is not adequate for the purpose of determining the applicant’s actual gross revenue referred to in subsection 17(2), the Minister may require the applicant to provide sales records that have been audited by a qualified independent auditor and those records are to be used for the purpose of determining the fee payable or the amount of the remission.

Omission

(2) If the applicant fails to provide to the Minister the audited sales records referred to in subsection (1) within 60 days after the day of the Minister’s request for those records, the difference between the fee specified in subsection 17(1) and the amount already paid is immediately payable.

Difference payable

(3) If the audited sales records referred to in subsection (1) establish that the amount already paid is less than the amount payable under section 17, the difference between those amounts is immediately payable.

Difference remitted

(4) If the audited sales records referred to in subsection (1) establish that the amount already paid is greater than the amount payable under section 17, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the applicant.

Licence Amendment

Sterile dosage forms

26. If the application to amend an establishment licence authorizing the holder to conduct one or more activities including fabricating drugs seeks to authorize the holder to fabricate drugs in sterile dosage forms for the first time at a building, the fee payable for the examination of the application is the basic fee set out in item 1 of column 2 of Schedule 2 for each building referred to in the application.

Activity

27. (1) If an application to amend an establishment licence seeks to add an activity at a building, the fee payable for the examination of the application for each building at which the activity is to be added is,

(a) if the amendment seeks to authorize the holder to fabricate drugs, the basic fee set out in item 1 of column 2 of Schedule 2;

(b) if the amendment seeks to authorize the holder to package/label drugs but not to fabricate drugs, the basic fee set out in item 1 of column 2 of Schedule 3;

(c) if the amendment seeks to authorize the holder to import drugs but not to fabricate or package/label drugs, the basic fee set out in item 1 of column 2 of Schedule 4;

(d) if the amendment seeks to authorize the holder to distribute drugs as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations but not to fabricate, package/label or import drugs, the basic fee set out in item 1 of column 2 of Schedule 4; and

(e) if the amendment seeks to authorize the holder to distribute drugs as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations, or to wholesale drugs or to conduct both activities, but not to fabricate, package/label or import drugs or to distribute drugs as a distributor referred to in paragraph C.01A.003(b) of those Regulations, the basic fee set out in section 22.

Category of drugs

(2) Subject to subsection (3), if an application to amend an establishment licence seeks to add a category in respect of an activity that is authorized by the licence at a building, the fee that is payable for the examination of the application for each building at which the category of drugs is to be added is,

(a) if the amendment seeks to authorize the holder to fabricate an additional category of drugs, the basic fee set out in item 1 of column 2 of Schedule 2;

(b) if the amendment seeks to authorize the holder to package/label an additional category of drugs, the basic fee set out in item 1 of column 2 of Schedule 3;

(c) if the amendment seeks to authorize the holder to import an additional category of drugs, the basic fee set out in item 1 of column 2 of Schedule 4;

(d) if the amendment seeks to authorize the holder to distribute an additional category of drugs as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations, the basic fee set out in item 1 of column 2 of Schedule 4;

(e) if the amendment seeks to authorize the holder to distribute an additional category of drugs as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations or to wholesale an additional category of drugs, the basic fee set out in section 22; and

(f) if the amendment seeks to authorize the holder to test an additional category of drugs, the basic fee set out in section 23.

Included categories

(3) If an application to amend an establishment licence seeks to add a category in respect of more than one activity referred to in paragraphs (2)(a) to (f), the fee payable under subsection (2) for the examination of the application is the highest applicable fee for those activities.

DIVISION 3

FEES FOR THE EXAMINATION OF DEALER’S LICENCE APPLICATIONS

Interpretation

Definitions

28. (1) The following definitions apply in this Division.

“controlled drug”
« drogue contrôlée »

“controlled drug” has the same meaning as in subsection G.01.001(1) of the Food and Drug Regulations.

“dealer’s licence”
« licence de distributeur autorisé »

“dealer’s licence” means

(a) a licence issued under section G.02.003.2 of the Food and Drug Regulations; or

(b) a licence issued under section 9.2 of the Narcotic Control Regulations.

“health care facility”
« établissement de santé »

“health care facility” means a facility that provides diagnostic or therapeutic services to patients. It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities.

“narcotic”
« stupéfiant »

“narcotic” has the same meaning as in section 2 of the Narcotic Control Regulations.

Words and expressions

(2) Unless the context otherwise requires, all other words and expressions used in this Division have the meanings assigned to them by Part G of the Food and Drug Regulations, the Controlled Drugs and Substances Act or the Narcotic Control Regulations.

Application

Non-application

29. This Division does not apply to

(a) any publicly funded health care facility;

(b) any branch or agency of the Government of Canada or of the government of a province; or

(c) any person or organization engaged only in scientific investigation.

Fees

Dealer’s licence

30. (1) The fee that is payable by the applicant for the examination of an application for a dealer’s licence is $4,510 for each premises at which activities are to be conducted under that licence.

Remission

(2) If the fee is greater than an amount equal to 1% of the applicant’s actual gross revenue from activities conducted under a dealer’s licence during the previous calendar year, remission is granted of the difference between those amounts if the applicant provides the statement referred to in subsection (5).

Timing of payment

(3) Subject to subsection (4), the fee is payable at the time of submitting the application for a dealer’s licence or the renewal of that licence under section 9 or 9.5 of the Narcotic Control Regulations or section G.02.003 or G.02.003.4 of the Food and Drug Regulations.

First year of activities

(4) If the applicant has not completed their first calendar year of conducting activities under the licence, the payment of the fee is deferred by one year.

Statement

(5) If an applicant is eligible for a remission under subsection (2), the applicant must provide with their application a statement certified by the individual responsible for the applicant’s financial affairs that sets out the applicant’s actual gross revenue referred to in subsection (2).

Remission — dealer’s licence and establishment licence

31. Remission is granted of an amount equal to the difference between the total of the fees payable under subsections 17(1) and 30(1) and an amount equal to 1% of the applicant’s actual gross revenue referred to in paragraph (a) if

(a) the total of the fees payable under subsections 17(1) and 30(1) is greater than an amount equal to 1% of the applicant’s actual gross revenue from activities conducted under their dealer’s licence during the previous calendar year;

(b) the dealer’s licence and the establishment licence were issued to the same holder and are related to the same activities conducted at the same premises;

(c) the applicant has not received a remission under subsection 17(2) or 30(2); and

(d) the applicant has provided the statement referred to in subsection 30(5).

Audited sales records

32. (1) If the Minister determines that, on the basis of any information available to that Minister, the statement provided under subsection 30(5) is not adequate for the purpose of determining the applicant’s actual gross revenue referred to in subsection 30(2), the Minister may require the applicant to provide sales records that have been audited by a qualified independent auditor and those records are to be used for the purpose of determining the fee payable or the amount of the remission.

Omission

(2) If the applicant fails to provide to the Minister the audited sales records referred to in subsection (1) within 60 days after the day of the Minister’s request for those records, the difference between the fee specified in subsection 30(1) and the amount already paid is immediately payable.

Difference payable

(3) If the audited sales records referred to in subsection (1) establish that the amount already paid is less than the amount payable under section 30, the difference between those amounts is immediately payable.

Difference remitted

(4) If the audited sales records referred to in subsection (1) establish that the amount already paid is greater than the amount payable under section 30, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the applicant.

DIVISION 4

FEES FOR RIGHT TO SELL DRUGS

Interpretation

Words and expressions

33. The words and expressions used in this Division have the meanings assigned to them by the Food and Drugs Act or the Food and Drug Regulations.

Fee

Annual fee

34. (1) If on October 1 of any year a manufacturer holds the identification number assigned to a drug under section C.01.014.2 of the Food and Drug Regulations, the fee that is payable by the manufacturer for the right to sell the drug is $1,020.

Remission — actual gross revenue

(2) If the fee is greater than an amount equal to 1.5% of the manufacturer’s actual gross revenue from the sale of the drug in Canada during the previous calendar year, remission is granted of the difference between those amounts if the applicant provides the statement referred to in subsection (5).

Timing of payment

(3) Subject to subsection (4), the fee is payable annually at the time the manufacturer furnishes the notification under section C.01.014.5 of the Food and Drug Regulations.

First year of activities

(4) If the manufacturer has not completed its first calendar year of selling a drug for which an identification number has been assigned, the payment of the fee is deferred by one year.

Statement

(5) If a manufacturer is eligible for a remission under subsection (2), the manufacturer must provide a statement certified by the individual responsible for the manufacturer’s financial affairs that sets out the manufacturer’s actual gross revenue referred to subsection (2).

Audited records

35. (1) If the Minister determines that, on the basis of any information available to the Minister, the statement provided under subsection 34(5) is not adequate for the purpose of determining the actual gross revenue from the sale of the drug in Canada during the previous calendar year, the Minister may require the manufacturer to provide sales records that have been audited by a qualified independent auditor and those records are to be used for the purpose of determining the fee payable or the amount of the remission.

Omission

(2) If the manufacturer fails to provide to the Minister the audited sales records within 60 days after the day of the Minister’s request for those records, the difference between the fee specified in subsection 34(1) and the amount already paid is immediately payable.

Difference payable

(3) If the audited sales records establish that the amount already paid is less than the amount payable under section 34, the difference between those amounts is immediately payable.

Difference remitted

(4) If the audited sales records establish that the amount already paid is greater than the amount payable under section 34, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the manufacturer.

PART 3

MEDICAL DEVICE FEES

DIVISION 1

INTERPRETATION

Definitions

36. (1) The following definitions apply in this Part.

“actual gross revenue”
« recettes brutes réelles »

“actual gross revenue” means the amount earned by a manufacturer during the fee verification period from sales in Canada of a medical device that is the subject of a medical device licence application that is referred to in section 38, 39 or 40.

“annual gross revenue”
« recettes brutes annuelles »

“annual gross revenue” means

(a) in section 47, the amount earned by a manufacturer during a calendar year from sales in Canada of a medical device in respect of which the manufacturer holds a medical device licence; and

(b) in sections 50 and 51, the amount earned by an establishment during a calendar year from sales in Canada of medical devices.

“anticipated gross revenue”
« recettes brutes prévues »

“anticipated gross revenue” means the amount that a manufacturer expects to earn during the fee verification period from sales in Canada of the medical device that is the subject of a medical device licence application that is referred to in section 38, 39 or 40.

“fee verification period”
« période de vérification du prix à payer »

“fee verification period”, in respect of a medical device that is the subject of a medical device licence application that is referred to in section 38, 39 or 40, means the period beginning on the day on which the medical device is first sold in Canada and ending two years after that day.

Words and expressions

(2) Unless the context otherwise requires, all other words and expressions used in this Part have the meanings assigned to them by the Food and Drugs Act or the Medical Devices Regulations.

DIVISION 2

FEES FOR EXAMINATION OF MEDICAL DEVICE LICENCE APPLICATIONS

Application

Applicable classes

37. This Division applies to medical devices that are subject to the Medical Devices Regulations, other than the provisions of Parts 2 and 3 of those Regulations, and that are classified into one of Classes II to IV under sections 6 and 7 of those Regulations.

Class II Medical Device Licence

Fee — Class II medical device

38. (1) The fee that is payable for the examination of an application for a Class II medical device licence submitted in accordance with section 32 of the Medical Devices Regulations is $350 and is payable by the manufacturer at the time that the application is submitted.

Reinstatement of a Class II medical device licence

(2) Every provision in this Division that applies to an application for a Class II medical device licence submitted in accordance with section 32 of the Medical Devices Regulations also applies to the request for the reinstatement of a Class II medical device licence under subsection 41(2) of those Regulations.

Class III or IV Medical Device Licence

Fee — Class III or IV medical device

39. (1) The fee that is payable by a manufacturer for the examination of an application for a Class III or IV medical device licence submitted in accordance with section 32 of the Medical Devices Regulations is

(a) in the case of a Class III medical device licence, for each category set out in column 1 of Schedule 6, the fee set out in column 2; or

(b) in the case of a Class IV medical device licence, for each category set out in column 1 of Schedule 7, the fee set out in column 2.

Reinstatement of Class III or IV medical device licence

(2) Every provision in this Division that applies to an application for a Class III or IV medical device licence submitted in accordance with section 32 of the Medical Devices Regulations also applies to the request for the reinstatement of a class III or IV medical device licence under subsection 41(2) of those Regulations.

Class III or IV Medical Device Licence Amendment

Fee — amendment to medical device licence

40. The fee that is payable by a manufacturer for the examination of an application for a medical device licence amendment submitted in accordance with paragraph 34(a) or (b) of the Medical Devices Regulations is

(a) in the case of a Class III medical device licence, the amount obtained by adding, for each category set out in column 1 of Schedule 6, the fee set out in column 2; or

(b) in the case of a Class IV medical device licence, the amount obtained by adding, for each category set out in column 1 of Schedule 7, the fee set out in column 2.

Timing of payment

Timing of payment

41. If the fee that is payable under section 39 or 40 is

(a) $5,000 or less, the fee is payable at the time that the application is submitted; or

(b) more than $5,000, the fee is payable as follows, namely,

(i) 10% on receipt of a notice from the Minister stating that the application has been found to be incomplete following a preliminary examination,

(ii) 75% on receipt of a notice from the Minister stating that the application has been found to be complete following a preliminary examination and has been accepted for further examination, and

(iii) 25% on receipt of a notice from the Minister stating that the examination of the application has been completed.

Deferred payment

Deferred payment

42. (1) If a manufacturer has not completed its first full fiscal year on the day on which it submits its medical device licence application, the Minister must grant it a one-year deferral of payment from the day that the application is submitted upon receiving a statement signed by the individual responsible for the manufacturer’s financial affairs specifying the commencement date of that fiscal year. At the end of the one-year period the manufacturer must pay all of the applicable amounts payable in accordance with section 41.

Inaccurate statement

(2) If the Minister determines, on the basis of any information available to the Minister, that a statement provided under subsection (1) is inaccurate, the Minister must notify the manufacturer that the payment cannot be deferred and is payable in accordance with section 41.

Remission

Remission — anticipated gross revenue

43. (1) Remission is granted of the amount by which the fee payable under section 38, 39 or 40, as applicable, exceeds 2.5% of the actual gross revenue from a medical device if that revenue is $100,000 or less and if

(a) the manufacturer provides

(i) a statement signed by the individual responsible for the manufacturer’s financial affairs indicating that the anticipated gross revenue is $100,000 or less and certifying that the fee payable under section 38, 39 or 40, as applicable, is greater than an amount equal to 2.5% of that anticipated gross revenue,

(ii) information establishing that the fee payable under section 38, 39 or 40, as applicable, is greater than an amount equal to 2.5% of the anticipated gross revenue, and

(iii) the amount of $50 for processing the remission, except in the case of the remission of a fee payable under section 38; and

(b) on the basis of the information provided under paragraph (a) and any other information available to the Minister, the Minister concludes that the actual gross revenue will be $100,000 or less and that the fee payable under section 38, 39 or 40, as applicable, will be greater than an amount equal to 2.5% of the actual gross revenue.

Amounts payable

(2) The fee is then payable as follows:

(a) an amount equal to 2.5% of the anticipated gross revenue is payable at the time and in the manner set out in section 38 or 41, as applicable; and

(b) the amount, if any, by which the lesser of the fee referred to in section 38, 39 or 40, as applicable, and 2.5% of the actual gross revenue exceeds the amount paid under paragraph (a) is payable 60 days after the day on which the fee verification period ends.

Sales records

(3) Within 60 days after the end of the fee verification period, the manufacturer must provide the Minister with sales records in regard to the sales of the medical device in Canada during the fee verification period, prepared in accordance with generally accepted accounting principles and certified by the individual responsible for the manufacturer’s financial affairs.

Omission

(4) If, within 60 days after the end of the fee verification period, the manufacturer has not provided to the Minister the sales records referred to in subsection (3), the difference between the fee referred to in section 38, 39 or 40, as applicable, and the amount already paid under paragraph (2)(a) is immediately payable.

Remission —actual gross revenue

44. If the amount paid under section 43 is greater than an amount equal to 2.5% of the manufacturer’s actual gross revenue from the medical device and that revenue is $100,000 or less, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the manufacturer.

Audited records

45. (1) If the Minister concludes, on the basis of any information available to the Minister, that the records provided in accordance with subsection 43(3) are not adequate to determine the manufacturer’s actual gross revenue, the Minister may require the manufacturer to provide sales records that have been audited by a qualified independent auditor and those records are to be used for the purpose of determining the fee payable or the amount of the remission.

Omission

(2) If, within 60 days after the day of the request for audited sales records, the manufacturer has not provided them to the Minister, the difference between the amount already paid and fee referred to in section 38, 39 or 40, as applicable, is immediately payable.

Difference payable

(3) If the audited sales records referred to in subsection (1) establish that the amount already paid is less than the amount payable under section 43, the difference between those amounts is immediately payable.

Difference remitted

(4) If the audited sales records referred to in subsection (1) establish that the amount already paid is greater than the amount payable under section 43, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the manufacturer.

Remission — General Council Decision

46. Remission is granted to the manufacturer of the amount of the fee referred to in section 38, 39 or 40, as applicable, in respect of a medical device if the manufacturer has received an authorization under section 21.04 of the Patent Act.

DIVISION 3

FEE FOR RIGHT TO SELL LICENSED CLASS II, III OR IV MEDICAL DEVICES

Fee

Fee

47. (1) If on November 1 of any year a manufacturer holds a Class II, III or IV medical device licence in accordance with section 26 of the Medical Devices Regulations, the fee that is payable by the manufacturer on that date for the right to sell the licensed medical device is

(a) $50 if its annual gross revenue from the sales of that medical device during its previous fiscal year is less than $20,000; and

(b) $330 if its annual gross revenue from the sales of that medical device during its previous fiscal year is $20,000 or more.

First year of activities

(2) If the manufacturer has not completed its first calendar year of selling a Class II, III or IV medical device for which the manufacturer holds the licence, the payment of the fee under subsection (1) is deferred by one year.

Statement of annual gross revenue

(3) The fee specified in paragraph (1)(a) must be accompanied by a statement signed by the individual responsible for the manufacturer’s financial affairs certifying that the annual gross revenue from the sales of the medical device is less than $20,000.

Audited sales records

48. (1) If the Minister determines, on the basis of any information available to the Minister, that the statement provided in accordance with subsection 47(3) is inaccurate, the Minister may require the manufacturer to provide sales records that have been audited by a qualified independent auditor and those records are to be used for the purpose of determining the fee payable or the amount of the remission.

Omission

(2) If, within 60 days after the day of the request for audited sales records, the manufacturer has not provided them to the Minister, the difference between the fee specified in paragraph 47(1)(b) and the amount already paid is immediately payable.

Difference payable

(3) If the audited sales records referred to in subsection (1) establish that the amount paid under paragraph 47(1)(a) was incorrect, the difference between the fee specified in paragraph 47(1)(b) and the amount already paid is immediately payable.

DIVISION 4

FEES FOR THE EXAMINATION OF AN APPLICATION FOR AN ESTABLISHMENT LICENCE

Application

Applicable classes

49. This Division applies to establishments that import or sell medical devices that are subject to the Medical Devices Regulations, other than the provisions of Parts 2 and 3 of those Regulations, and that are classified into one of Classes I to IV under sections 6 and 7 of those Regulations.

Fee

Fee payable

50. (1) The fee that is payable by an establishment in respect of the examination of an application for an establishment licence or for the annual review of that licence or in respect of the reinstatement of such a licence at the request of the holder following the correction of the situation that gave rise to its suspension is $7,200.

Remission

(2) If the amount of the fee is greater than an amount equal to 1% of the establishment’s annual gross revenue for the previous calendar year, remission is granted of the difference between those amounts if the establishment submits the statement referred to in subsection (5).

Timing of payment

(3) Subject to subsection (4), the fee is payable on the day on which the establishment submits the application for the establishment licence or for the annual review of that licence or on the day of the reinstatement of the licence.

First year of activities

(4) If the establishment has not completed its first calendar year of conducting activities under the establishment licence, the payment of the fee is deferred by one year.

Statement

(5) If an establishment is eligible for a remission under subsection (2), the establishment must provide with its application for an establishment licence or for the annual review of that licence or with its request for the reinstatement of the licence, a statement certified by the individual responsible for the establishment’s financial affairs that sets out the establishment’s annual gross revenue referred to in subsection (2).

Verification of Annual Gross Revenue

Audited records

51. (1) If the Minister determines, on the basis of any information available to the Minister, that the statement provided under subsection 50(5) is not adequate for the purpose of determining the establishment’s annual gross revenue referred to in subsection 50(2), the Minister may require the establishment to provide sales records that have been audited by a qualified independent auditor and those records are to be used for the purpose of determining the fee payable or the amount of the remission.

Full fee payable

(2) If, within 60 days after the day of the request for audited sales records, the establishment has not provided them to the Minister, the difference between the fee specified in subsection 50(1) and the amount already paid is immediately payable.

Correct fee payable on verification

(3) If the audited sales records referred to in subsection (1) establish that the amount already paid is less than the amount payable under section 50, the difference between those amounts is immediately payable.

Remission

(4) If the audited sales records referred to in subsection (1) establish that the amount already paid is greater than the amount payable under section 50, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the establishment.

PART 4

TRANSITIONAL PROVISION, REPEALS AND COMING INTO FORCE

TRANSITIONAL PROVISION

Fee for prior application

52. The fee payable for the examination of an application, submission or supplement that is filed before the coming into force of these Regulations is the fee that is specified by the applicable regulation that is in effect at the time of filing.

REPEALS

53. The Drug Evaluation Fees Regulations (see footnote 1) are repealed.

54. The Fees in Respect of Medical Devices Regulations (see footnote 2) are repealed.

COMING INTO FORCE

Registration

55. These Regulations come into force on the day on which they are registered.

SCHEDULE 1
(Section 6)

FEES FOR EXAMINATION SERVICES

Item

Column 1

Submission Class

Column 2

Description

Column 3

Fee ($) 

1.

New active substance

Submissions in support of a drug, excluding a disinfectant, that contains a medicinal ingredient not previously approved in a drug for sale in Canada and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph.

303,480

2.

Clinical or non-clinical data and chemistry and manufacturing data

Submissions based on clinical or non-clinical data and chemistry and manufacturing data for a drug that does not include a new active substance.

153,710

3.

Clinical or non-clinical data only

Submissions based only on clinical or non-clinical data for a drug that does not include a new active substance.

71,740

4.

Comparative studies

Submissions based on comparative studies (e.g. clinical or non-clinical data, bioavailability, pharmacokinetic and pharmacodynamic data) with or without chemistry and manufacturing data for a drug that does not include a new active substance.

43,360

5.

Chemistry and manufacturing data only

Submissions based only on chemistry and manufacturing data for a drug that does not include a new active substance.

20,500

6.

Published data only

Submissions based only on published clinical or non-clinical data for a drug that does not include a new active substance.

17,000

7.

Switch from prescription to non-prescription status

Submissions based only on data that support the modification or removal of the listing of a medicinal ingredient on Schedule F to the Food and Drug Regulations (i.e. identical claim for existing drug).

41,280

8.

Labelling only

Submissions of labelling material (i.e. does not include supporting clinical or non-clinical data or chemistry and manufacturing data.)

2,760

9.

Administrative submission

Submissions in support of a manufacturer or product name change.

285

10.

Disinfectants

Submissions and applications that include data in support of a disinfectant.

3,820

11.

Identification number (DIN) application — labelling standards

Applications attesting to compliance with a labelling standard or Category IV Monograph for a drug that does not include clinical or non-clinical data or chemistry and manufacturing data.

1,530

SCHEDULE 2
(Sections 18 and 26 and paragraphs 27(1)(a) and (2)(a))

ESTABLISHMENT LICENCE FEES — FABRICATION OF DRUGS

Item

Column 1

Description

Column 2

Fee ($)

1.

Basic fee

15,450

2.

Each additional category

 3,870

3.

Dosage form classes:

(a) 2 classes

 7,730

(b) 3 classes

15,450

(c) 4 classes

19,320

(d) 5 classes

23,180

(e) 6 classes

27,040

(f) each additional class

 1,550

4.

Sterile dosage forms

 7,730

SCHEDULE 3
(Section 19 and paragraphs 27(1)(b) and (2)(b))

ESTABLISHMENT LICENCE FEES — PACKAGING / LABELLING OF DRUGS

Item

Column 1

Description

Column 2

Fee ($)

1.

Basic fee

10,330

2.

Each additional category

2,580

3.

Dosage form classes:

(a) 2 classes

5,150

(b) 3 or more classes

7,730

SCHEDULE 4
(Sections 20 and 21 and paragraphs 27(1)(c) and (d) and (2)(c) and (d))

ESTABLISHMENT LICENCE FEES — IMPORTATION AND DISTRIBUTION OF DRUGS

Item

Column 1

Description

Column 2

Fee ($)

1.

Basic fee

6,440

2.

Each additional category

1,610

3.

Dosage form classes:

(a) 2 classes

3,220

(b) 3 or more classes

6,440

4.

Each fabricator

1,550

5.

Each additional dosage form class for each fabricator

 780

SCHEDULE 5
(Section 24)

ESTABLISHMENT LICENCE FEES — DRUG ANALYSIS

Item

Column 1

Description

Column 2

Fee ($)

1.

Vaccines

25,750

2.

Drugs, not included in items 1, 6 and 9 of this Schedule, that are listed in Schedule D to the Food and Drugs Act

10,300

3.

Drugs for human use that are listed in Schedule F to the Food and Drug Regulations or that are controlled drugs or narcotics

7,730

4.

Drugs for human use, not included in any other item, for which a drug identification number (DIN) has been assigned

3,870

5.

Radiopharmaceuticals

0

6.

Whole blood and its components

0

7.

Hemodialysis products

0

8.

Drugs that are labelled as disinfectants, including those listed in paragraph 9(f) of this schedule, but excluding other drugs labelled as disinfectants of medical devices

0

9.

Drugs that meet the requirements of a class monograph having one of the following titles:

(a) “Acne Therapies”
(b) “Antidandruff Products”
(c) “Antiperspirants”
(d) “Antiseptic Skin Cleansers”
(e) “Athlete’s Foot Treatments”
(f) “Contact Lens Disinfectants”
(g) “Fluoride Containing Anti-Caries Products”
(h) “Medicated Skin Care Products”
(i) “Sunburn Protectants”
(j) “Throat Lozenges”

 


0
0
0
0
0
0
0
0
0
0

SCHEDULE 6
(Paragraphs 39(1)(a) and 40(a))

CLASS III MEDICAL DEVICES

Item

Column 1

Category

Column 2

Fee ($)

1.

Licence application

5,050

2.

Licence application for a near patient in vitro diagnostic device

8,600

3.

Change referred to in paragraph 34(a) of the Medical Devices Regulations that relates to manufacturing

1,270

4.

Any other change referred to in paragraph 34(a) or (b) of the Medical Devices Regulations

4,730

SCHEDULE 7
(Paragraphs 39(1)(b) and 40(b))

CLASS IV MEDICAL DEVICES

Item

Column 1

Category

Column 2

Fee ($)

1.

Licence application

11,750

2.

Licence application for devices that contain human or animal tissue

10,960

3.

Licence application for near patient in vitro diagnostic device

20,030

4.

Change referred to in paragraph 34(a) of the Medical Devices Regulations that relates to manufacturing

1,270

5.

Any other change referred to in paragraph 34(a) or (b) of the Medical Devices Regulations

5,390

[46-1-o]

Footnote a
S.C. 1991, c. 24, s. 6

Footnote b
S.C. 1991, c. 24, s. 6

Footnote c
R.S., c. F-11

Footnote d
S.C. 1991, c. 24, s. 7(2)

Footnote 1
SOR/95-424

Footnote 2
SOR/98-432