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.

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:

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:

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:

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:

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

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

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:

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:

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

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
  • Licence for micro-cultivation
$1,675 $1,709
  • Licence for standard cultivation
$3,350 $3,417
  • Licence for a nursery
$1,675 $1,709
  • Licence for micro-processing
$1,675 $1,709
  • Licence for standard processing
$3,350 $3,417
  • Licence for sale for medical purposes
$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