Canada Gazette, Part I, Volume 154, Number 13: GOVERNMENT NOTICES
March 28, 2020
BANK OF CANADA
BANK OF CANADA ACT
Amendment to policy for buying and selling securities
Notice is hereby given that the above-mentioned notice was published as Extra Vol. 154, No. 2, on Wednesday, March 18, 2020.
DEPARTMENT OF HEALTH
FOOD AND DRUGS ACT
Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19
Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment,
Therefore, the Minister of Health, pursuant to subsection 30.1(1) footnote a of the Food and Drugs Act footnote b, makes the annexed Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.
Ottawa, March 18, 2020
Patricia Hajdu
Minister of Health
Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19
Interpretation
Definitions
1 The following definitions apply in this Interim Order.
- COVID-19 medical device means a medical device that is manufactured, sold or represented for use in relation to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). (instrument médical destiné à être utilisé à l’égard de la COVID-19)
- foreign regulatory authority means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of medical devices within its jurisdiction and that may take enforcement action to ensure that medical devices marketed within its jurisdiction comply with the applicable legal requirements. (autorité réglementaire étrangère)
- incident means any incident involving a COVID-19 medical device that
- (a) is related to a failure of the device or a deterioration in its quality or effectiveness, or any inadequacy in its labelling or in its directions for use; or
- (b) has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so were it to recur. (incident)
- List of Medical Devices for Expanded Use means the List of Medical Devices for Expanded Use in Relation to the COVID-19 Pandemic that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux destinés à un usage supplémentaire)
- Regulations means the Medical Devices Regulations. (Règlement)
Words and expressions
2 Unless the context requires otherwise, words and expressions used in this Interim Order have the same meaning as in the Regulations.
Importation and sale
3 Part 1 of the Regulations, with the exception of sections 52 to 56 and 63 to 65.1, does not apply to the importation or sale of a COVID-19 medical device if the following conditions are met:
- (a) the Minister determines that there is an urgent public health need for the importation or sale of the device;
- (b) the manufacturer of the device has filed with the Minister an application for the authorization of importation or sale of the device in a form established by the Minister;
- (c) the Minister has issued the authorization; and
- (d) the authorization has not been cancelled.
Application
4 (1) An application for the authorization of importation or sale of a COVID-19 medical device must contain sufficient information and material to enable the Minister to determine whether to issue the authorization and must include the following:
- (a) the name of the device;
- (b) the class of the device;
- (c) the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
- (d) the name and address of the manufacturer as it appears on the device label;
- (e) the address where the device is manufactured, if different from the one referred to in paragraph (d);
- (f) the diagnosis, treatment, mitigation or prevention for which the device is required;
- (g) the known information in relation to the quality, safety and effectiveness of the device;
- (h) the directions for use, unless directions are not required, for the device to be used safely and effectively;
- (i) an attestation by the applicant that documented procedures are in place in respect of distribution records, complaint handling, incident reporting and recalls; and
- (j) a copy of the label of the device.
Class III and IV devices
(2) An application in respect of a Class III or IV COVID-19 medical device must contain, in addition to the information and material referred to in subsection (1), the following:
- (a) a description of the materials used in the manufacture and packaging of the device; and
- (b) a list of the countries, other than Canada, where the device has been sold, the total number of units sold in those countries and a summary of any reported problems with the device and any recalls of the device in those countries.
Foreign regulatory authority
(3) Despite subsection (1) and, if applicable, subsection (2), the application need not include the information and material referred to in paragraph (1)(g) and, if applicable, paragraphs (2)(a) and (b) if the applicant provides information that demonstrates that the sale of the COVID-19 medical device is authorized by a foreign regulatory authority and has not been suspended.
Issuance
5 The Minister must issue the authorization for importation or sale if the following requirements are met:
- (a) the applicant has submitted an application to the Minister that meets the requirements set out in subsection 4(1) and, if applicable, subsection 4(2);
- (b) the applicant has submitted to the Minister all additional information or material, including samples, requested under section 9;
- (c) the Minister has sufficient evidence to support the conclusion that the benefits associated with the COVID-19 medical device outweigh the risks, having regard to the uncertainties relating to the benefits and risks and the urgent public health need; and
- (d) the Minister determines that the health or safety of patients, users or other persons will not be unduly affected.
Amendment
6 A person must not sell a COVID-19 medical device in respect of which an authorization for importation or sale has been issued and has not been cancelled if any of the matters referred to in subsection 4(1) and, if applicable, subsection 4(2) are significantly different from the information or material contained in the application, unless
- (a) the manufacturer has filed with the Minister an application to amend the authorization;
- (b) the Minister determines that the requirements set out in paragraphs 5(b) to (d) are met; and
- (c) the Minister amends the authorization.
Terms and conditions
7 The Minister may, at any time, impose terms and conditions on the authorization for importation or sale of a COVID-19 medical device or amend those terms and conditions.
Cancellation
8 The Minister may cancel the authorization for importation or sale of a COVID-19 medical device, giving reasons, if
- (a) the Minister determines that the requirements under paragraphs 5(c) and (d) are no longer met;
- (b) the Minister determines that the terms and conditions imposed under section 7 are not met;
- (c) a medical device licence has been issued for the COVID-19 medical device under section 36 of the Regulations; or
- (d) the authorization for sale of the COVID-19 medical device that has been issued by a foreign regulatory authority is suspended or cancelled.
Additional information and material
9 The Minister may request a person that has submitted an application for the issuance of an authorization for importation or sale of a COVID-19 medical device or a holder of such an authorization to submit any additional information or any material, including samples, that is necessary to enable the Minister to determine whether to issue, amend or cancel the authorization.
Labelling
10 A person must not import or sell a COVID-19 medical device unless the device has a label that sets out the following information:
- (a) the name of the device;
- (b) the name and address of the manufacturer;
- (c) the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or device group family;
- (d) in the case of a Class III or IV device, the control number;
- (e) if the contents are not readily apparent, an indication of what the package contains, expressed in terms appropriate to the device, such as the size, net weight, length, volume or number of units;
- (f) an indication that the device is sterile, if the manufacturer intends the device to be sold in a sterile condition;
- (g) the expiry date of the device, if the device has one, to be determined by the manufacturer on the basis of the component that has the shortest projected useful life;
- (h) unless self-evident to the intended user, the medical conditions, purposes and uses for which the device is manufactured, sold or represented, as well as the performance specifications of the device if those specifications are necessary for proper use;
- (i) the directions for use, unless directions are not required, for the device to be used safely and effectively; and
- (j) any special storage conditions applicable to the device.
Importation — copy of authorization
11 Each shipment of a COVID-19 medical device that is imported into Canada must be accompanied by a copy of the authorization for importation.
Incident reporting
12 The holder of an authorization for importation or sale of a COVID-19 medical device must, within 10 days after becoming aware of an incident in Canada, report the incident to the Minister and specify the nature of the incident and the circumstances surrounding it.
Expanded use
13 Part 1 of the Regulations does not apply to the importation or sale of a medical device or a COVID-19 medical device that is set out in column 1 of the List of Medical Devices for Expanded Use for the expanded use set out in column 2 if the following conditions are met:
- (a) the Minister determines that there is an urgent public health need for the expanded use of the medical device or the COVID-19 medical device;
- (b) the Minister has evidence to support the conclusion that the benefits associated with the expanded use outweigh the risks, having regard to the uncertainties relating to the benefits and risks and the urgent public health need; and
- (c) the Minister determines that the health or safety of patients, users or other persons will not be unduly affected.
Supplementary information
14 The Minister must publish on a Government of Canada website supplementary information pertaining to the expanded use of a medical device or a COVID-19 medical device, including
- (a) a statement of the expanded use;
- (b) a statement of the known and potential benefits and the known and potential risks; and
- (c) any supplement to the directions for use, unless a supplement is not required, for the device to be used safely and effectively.
Information request
15 (1) The Minister may request from the holder of a medical device licence or the holder of an authorization for importation or sale of a COVID-19 medical device, in respect of a device set out in column 1 of the List of Medical Devices for Expanded Use, any information in relation to its expanded use set out in column 2 that the holder possesses or has reasonable access to.
Form and manner
(2) The holder of the licence or authorization must provide the information in the time, form and manner specified by the Minister.
EXPLANATORY NOTE
(This note is not part of the Interim Order.)
Proposal
The Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (the Interim Order), made by the Minister of Health on March 18, 2020, allows for the expedited authorization of the importation or sale of medical devices used in the diagnosis, treatment, mitigation, or prevention of COVID-19. The Interim Order allows the Minister to use discretion in the level of evidence required to demonstrate the safety and effectiveness of the devices authorized through this process to meet an urgent public health need.
The Minister may make interim orders under subsection 30.1(1) of the Food and Drugs Act, if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment. This Order in Council approves the Interim Order under subsection 30.1(2) of that Act, allowing the Interim Order to remain in effect for up to one year after it is made.
Objective
The objective of the proposal is to mitigate and prevent infections caused by SARS-CoV-2 and to protect the health and safety of Canadians in relation to COVID-19 by providing timelier access to medical devices used in the diagnosis, treatment, mitigation, or prevention of COVID-19.
Background
COVID-19 is the infectious respiratory disease caused by the most recently discovered coronavirus, SARS-CoV-2. The outbreak of COVID-19 began in Wuhan, China, in December 2019. COVID-19 infection has been known to cause respiratory symptoms, fever, cough, shortness of breath, and breathing difficulties. In more severe cases, COVID-19 infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and death.
The World Health Organisation (WHO) declared a global pandemic related to COVID-19 on March 11, 2020. There are now more than 214 000 cases in at least 150 countries, and over 8 500 people have lost their lives. The number of confirmed cases in Canada as of March 18, 2020, has exceeded 600; however, the situation is changing rapidly.
Diagnostic testing in Canada has been limited as there are no commercial tests available on the market. The tests currently available in Canada are laboratory-developed tests, based on methodology from Canada’s National Microbiology Laboratory. The limited supply and potential shortages in reagents required for these tests are putting Canadians at risk. Additionally, as this disease has progressed in other jurisdictions, there have been shortages of equipment used to prevent the disease (e.g. personal protective equipment for front-line workers) and to treat the disease in its critical stages (e.g. ventilators).
Implications
The Interim Order allows for an expedited authorization pathway for the importation or sale of medical devices used in the diagnosis, treatment, mitigation, or prevention of COVID-19. This expedited authorization process allows the Minister to use discretion in the level of evidence required to demonstrate the safety and effectiveness of a medical device authorized through this process. Devices authorized under the Interim Order are not subject to cost recovery fees.
The Interim Order provides an expedited authorization pathway (i) for new COVID-19-related medical devices that are not yet licensed in Canada or other jurisdictions, (ii) for COVID-19-related uses for existing devices licensed under the Medical Devices Regulations, and (iii) for COVID-19-related medical devices that leverage an authorization of a device from a foreign regulatory authority. The Interim Order will also provide a mechanism for the Minister to expand the indications for use of specific devices without having to specifically apply for such indications. This would apply to devices currently licensed under the Medical Devices Regulations or authorized under the Interim Order, to include COVID-19-related diagnosis, treatment, mitigation, or prevention claims based on the known evidence.
The use of this mechanism or the expedited authorization pathway is predicated on the Minister’s determination that evidence supports the conclusion that the benefits outweigh the risks associated with the device, taking into account the uncertainties related to the benefits and risks as well as the urgent public health need. This will allow for exercising discretion, on a case-by-case basis, in the level of evidence required to demonstrate the safety and effectiveness of a device in order to meet an urgent public health need in a timelier manner.
Devices authorized under the Interim Order would still be subject to incident reporting, reporting of a voluntary recall, and distribution-related record-keeping requirements. In addition, the Minister may impose or amend terms and conditions, and request additional information in relation to a COVID-19 medical device submission, authorization, or expanded use determination, at any time. Health Canada will continue to monitor the safety and effectiveness of the devices accessed under the Interim Order and will take immediate action, including the cancellation of authorizations, if required to protect the health and safety of Canadians.
Consultation
Manufacturers of diagnostic test kits were consulted during the development of the Interim Order regarding their ability to supply the Canadian market. In advance of the Interim Order coming into effect, access to diagnostic test kits has been facilitated through Health Canada’s Medical Devices Special Access Program (SAP). Two diagnostic tests will become more readily accessible to Canadians through the Interim Order. Due to the urgent nature of the Interim Order, broad stakeholder consultation, including with provincial and territorial governments, was not possible. However, it is expected that these stakeholders will be supportive.
Within the Health Portfolio, the Public Health Agency of Canada was consulted and is supportive of the Interim Order. Additionally, the Canadian Border Services Agency has been made aware that medical devices authorized under the Interim Order will be accompanied by a copy of the authorization to facilitate identification and importation at the border.
Contact
Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite 14
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address Locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca
DEPARTMENT OF HEALTH
CANNABIS ACT
Cannabis Fees Order: Increase to fees set out in sections 3, 4 and 5
The Cannabis Fees Order (SOR/2018-198) was published in the Canada Gazette, Part II, on October 17, 2018, and came into force on the same date.
Section 2 of the Order provides that “the fees set out in sections 3 to 5 are to be adjusted in each fiscal year on April 1 by the percentage change over 12 months in the April All-items Consumer Price Index for Canada, as published by Statistics Canada under the Statistics Act, for the previous fiscal year and rounded to the next highest dollar.”
Notice is hereby given that the following fees will be adjusted effective April 1, 2020, by the 2019 Consumer Price Index of 2.0%.
| Fee Description | Current Fee | Adjusted Fee Effective April 1, 2020 |
|---|---|---|
| Screening of a licence application | ||
|
$1,675 | $1,709 |
|
$3,350 | $3,417 |
|
$1,675 | $1,709 |
|
$1,675 | $1,709 |
|
$3,350 | $3,417 |
|
$3,350 | $3,417 |
| Application for security clearance | $1,691 | $1,725 |
| Application for import or export permit | $624 | $637 |
John Clare
Director General
Strategic Policy Directorate
Controlled Substances and Cannabis Branch
DEPARTMENT OF HEALTH
DEPARTMENT OF HEALTH ACT
Notice of annual increase of Health Canada’s Drug Master Files and Certificate of Pharmaceutical Product fees
Notice is hereby given that the Minister of Health, under the Ministerial Authority to Enter into Contract, hereby updates the fees that are payable for the provision of Drug Master Files and Certificate of Pharmaceutical Product services by 2%, beginning April 1, 2020.
The current fees and the fees updated as of April 1, 2020, are listed below.
Any inquiries or comments about the updated fees can be directed to Etienne Ouimette, Director General, Resource Management and Operations Directorate, Health Products and Food Branch, 613‑957‑6690 (telephone) or hc.cro-brc.sc@canada.ca (email).
| Services | Fee as of April 1, 2019 | Fee as of April 1, 2020 |
|---|---|---|
| Certificate of Pharmaceutical Product (or a supplemental copy of a Certificate of Pharmaceutical Product) | $90 | $92 |
| New Master Files — file registration | $1,248 | $1,273 |
| Drug Master Files — letter of access | $176 | $180 |
| Drug Master Files — update | $541 | $552 |
DEPARTMENT OF HEALTH
FINANCIAL ADMINISTRATION ACT
Notice of annual increase of fees for dealer’s licences
Notice is hereby given, under section 19.2 of the Financial Administration Act, that in keeping with section 4 of the 2011 Fees in Respect of Drugs and Medical Devices Regulations, the fee for a Dealer’s Licence: Human Drugs will increase by the annual 2% amount, rounded up to the nearest dollar. Under section 17.1 of the Service Fees Act (a fee is adjusted in each fiscal year — on the anniversary of a date that is selected by the responsible authority with respect to the fee before the first adjustment — by the percentage change over 12 months in the April All-items Consumer Price Index for Canada, as published by Statistics Canada under the Statistics Act, for the previous fiscal year), the Dealer’s Licence: Veterinary Drugs (Licensed Dealers for Controlled Drugs and Narcotics [Veterinary Use] Fees Regulations) will be increased by 2%. Health Canada has chosen April 1 as the anniversary date.
The current fees and the fees updated as of April 1, 2020, are listed below.
Any inquiries or comments about the updated fees can be directed to Etienne Ouimette, Director General, Resource Management and Operations Directorate, Health Products and Food Branch, 613‑957‑6690 (telephone) or hc.cro-brc.sc@canada.ca (email).
| Fee as of April 1, 2019 | Fee as of April 1, 2020 | |
|---|---|---|
| Dealer’s Licence (human drugs) | $5,288 | $5,394 |
| Dealer’s Licence (veterinary drugs) | $1,788.50 | $1,824.27 |
DEPARTMENT OF HEALTH
PATENT ACT
Notice of annual increase of fees pursuant to the Certificate of Supplementary Protection Regulations
Notice is hereby given that, in keeping with subsection 9(1) of the Certificate of Supplementary Protection Regulations, the fee will increase by the annual 2% amount, rounded up to the nearest dollar.
The current fee and the fee updated as of April 1, 2020, are listed below.
Any inquiries or comments about the updated fee can be directed to Etienne Ouimette, Director General, Resource Management and Operations Directorate, Health Products and Food Branch, 613‑957‑6690 (telephone) or hc.cro-brc.sc@canada.ca (email).
| Subsection in Certificate of Supplementary Protection Regulations | Fee as of April 1, 2019 | Fee as of April 1, 2020 | |
|---|---|---|---|
| Certificate of supplementary protection | 9(1) | $9,376 | $9,564 |
DEPARTMENT OF TRANSPORT
CANADA TRANSPORTATION ACT
Levy on shipments of crude oil by rail
Pursuant to subsection 155.4(4) footnote * of the Canada Transportation Act (the Act), the amount of the levy in respect of payments into the Fund for Railway Accidents Involving Designated Goods required by subsection 155.7(1)footnote * of the Act is $1.79 per tonne during the year commencing April 1, 2020.
Marc Garneau, P.C., M.P.
Minister of Transport
BANK OF CANADA
Statement of financial position as at February 29, 2020
(Millions of dollars) Unaudited
| ASSETS | Amount | Total |
|---|---|---|
| Cash and foreign deposits | 6.3 | |
| Loans and receivables | ||
| Securities purchased under resale agreements | 15,484.5 | |
| Advances | — | |
| Other receivables | 5.1 | |
| 15,489.6 | ||
| Investments | ||
| Treasury bills of Canada | 25,034.8 | |
| Canada Mortgage Bonds | 512.6 | |
| Government of Canada bonds | 80,587.9 | |
| Other investments | 462.4 | |
| 106,597.7 | ||
| Capital assets | ||
| Property and equipment | 585.3 | |
| Intangible assets | 62.5 | |
| Right-of-use leased assets | 50.1 | |
| Other assets | 64.2 | |
| Total assets | 122,855.7 | |
| LIABILITIES AND EQUITY | Amount | Total |
|---|---|---|
| Bank notes in circulation | 89,146.8 | |
| Deposits | ||
| Government of Canada | 25,658.1 | |
| Members of Payments Canada | 249.6 | |
| Other deposits | 6,281.5 | |
| 32,189.2 | ||
| Securities sold under repurchase agreements | — | |
| Other liabilities | 965.4 | |
| 122,301.4 | ||
| Equity | ||
| Share capital | 5.0 | |
| Statutory and special reserves | 125.0 | |
| Available-for-sale reserve | 424.3 | |
| 554.3 | ||
| Total liabilities and equity | 122,855.7 | |
I declare that the foregoing statement is correct according to the books of the Bank.
Ottawa, March 16, 2020
Adelle Laniel
Deputy Managing Director, Financial Services
I declare that the foregoing statement is to the best of my knowledge and belief correct, and shows truly and clearly the financial position of the Bank, as required by section 29 of the Bank of Canada Act.
Ottawa, March 16, 2020
Stephen S. Poloz
Governor