Second Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose 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) of the Food and Drugs Act, makes the annexed Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19.

Ottawa, March 1, 2021

Patricia Hajdu
Minister of Health

Interpretation

Definitions

1 (1) The following definitions apply in this Interim Order.

business day means a day other than a Saturday or a Sunday or other holiday. (jour ouvrable)

pest control product has the same meaning as in subsection 2(1) of the Pest Control Products Act. (produit antiparasitaire)

Other words and expressions

(2) Unless the context requires otherwise, words and expressions used in this Interim Order have the same meaning as in the Food and Drug Regulations or the Medical Devices Regulations, as applicable.

Drugs

Definitions

Definitions

2 The following definitions apply in this section and in sections 3 to 13.

biocide means a drug that

1. (a) is not a pest control product whose use is regulated under the Pest Control Products Act; and
2. (b) is intended to destroy or irreversibly inactivate micro-organisms on an inanimate surface, other than the surface of an invasive device. (biocide)

designated biocide means a biocide that is set out in the List of Biocides for Exceptional Importation and Sale. (biocide désigné)

designated drug means a drug that is set out in the List of Drugs for Exceptional Importation and Sale or that is part of a class of drugs that is set out in that List. It does not include a biocide. (drogue désignée)

drug does not include

1. (a) a veterinary health product;
2. (b) a natural health product as defined in subsection 1(1) of the Natural Health Products Regulations;
3. (c) a cell, organ or tissue as those terms are defined in section 1 of the Safety of Human Cells, Tissues and Organs for Transplantation Regulations; and
4. (d) blood as defined in section 1 of the Blood Regulations. (drogue)

List of Biocides for Exceptional Importation and Sale means the List of Biocides for Exceptional Importation and Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste des biocides destinés aux importations et aux ventes exceptionnelles)

List of Drugs for Exceptional Importation and Sale means the List of Drugs for Exceptional Importation and Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste des drogues destinées aux importations et aux ventes exceptionnelles)

Exceptional Importation and Sale

Drugs Other than Biocides

Non-application

3 Subject to section 4 and subsection 5(1), the following provisions of the Food and Drug Regulations do not apply to a designated drug that is imported:

1. (a) sections A.01.044, A.01.051 and A.01.060; and
2. (b) the provisions of Part C other than
   1. (i) sections C.01.020.1, C.01.040.3 to C.01.049 and C.01.051, and
   2. (ii) the provisions of Divisions 1A and 2.

Prohibition — sale

4 (1) The prohibition set out in section C.01.016 of the Food and Drug Regulations applies to the sale of a designated drug that is imported.

Serious adverse drug reaction reporting

(2) Despite subsection (1), the manufacturer of the designated drug is required to comply only with the requirements set out in sections C.01.017 and C.01.019 of those Regulations.

Finished product testing

5 (1) Section C.02.019 of the Food and Drug Regulations does not apply to an importer in respect of a designated drug that they import.

Timing of testing

(2) An importer of a designated drug must perform the finished product testing on a sample of the drug that is taken either

1. (a) after receipt of each lot or batch of the drug on their premises in Canada, or
2. (b) before receipt of each lot or batch of the drug on their premises in Canada if the following conditions are met:
   1. (i) the importer has evidence satisfactory to the Minister to demonstrate that lots or batches of the drug sold to them by the vendor of the lot or batch are consistently manufactured in accordance with and consistently comply with the specifications for that drug, and
   2. (ii) the drug has not been transported or stored under conditions that may affect its compliance with the specifications for that drug.

Visual inspection

(3) If the importer receives on their premises in Canada a lot or batch of a designated drug whose useful life is more than 30 days, the importer must visually inspect the lot or batch to confirm the identity of the product.

Non-application

(4) Subsections (2) and (3) do not apply to the importer if the designated drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building and both of the following conditions are met:

1. (a) the address of the building is set out in their establishment licence, and
2. (b) they retain a copy of the batch certificate for each lot or batch of the drug that they receive.

Information request

6 (1) The Minister may request from an importer of a designated drug any of the information referred to in paragraphs C.02.020(1)(a), (b) and (d) of the Food and Drug Regulations.

Obligation to provide information

(2) The importer must provide the requested information electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister. The time limit cannot be less than 24 hours after the request is made unless the Minister has reasonable grounds to believe that there is a serious and imminent risk of injury to human health.

Non-application

7 Subsections 5(2) and (3) and section 6 do not apply in respect of a designated drug that is not subject to Division 2 of Part C of the Food and Drug Regulations.

Notification

8 (1) An importer of a designated drug must notify the Minister in accordance with subsection (2) not later than the fifth business day before the day on which the drug is imported.

Content

(2) The notification must be provided electronically in a format specified by or acceptable to the Minister and contain the following information:

1. (a) the importer’s name and contact information;
2. (b) the name and contact information of each fabricator, packager/labeller and tester of the designated drug and the address of each building in which it is fabricated, packaged/labelled or tested;
3. (c) in respect of the designated drug that is intended to be imported,
   1. (i) its brand name,
   2. (ii) its medicinal ingredients,
   3. (iii) its dosage form,
   4. (iv) its strength,
   5. (v) its route of administration, and
   6. (vi) its identifying code or number, if any, assigned in the country in which it is authorized for sale;
4. (d) a detailed description of the designated drug’s conditions of use;
5. (e) the intended port of entry into Canada;
6. (f) the estimated date of arrival of the shipment of the designated drug;
7. (g) the customs identification number for the shipment of the designated drug; and
8. (h) the total quantity of the designated drug that is intended to be imported.

Accessibility of information

9 An importer of a designated drug that sells it must ensure that the information referred to in paragraph 8(2)(d) is available

1. (a) in a manner that permits the safe use of the drug; and
2. (b) in both English and French.

Biocides

Non-application

10 Subject to section 11, the following provisions of the Food and Drug Regulations do not apply to a designated biocide that is imported:

1. (a) sections A.01.044, A.01.051 and A.01.060; and
2. (b) the provisions of Part C other than sections C.01.020.1 and C.01.051.

Prohibition — sale

11 (1) The prohibition set out in section C.01.016 of the Food and Drug Regulations applies to the sale of a designated biocide that is imported.

Serious adverse drug reaction reporting

(2) Despite subsection (1), the manufacturer of the designated biocide is required to comply only with the requirements set out in sections C.01.017 and C.01.019 of those Regulations.

Notification

12 (1) An importer of a designated biocide must notify the Minister in accordance with subsection (2) not later than the fifth business day before the day on which the biocide is imported.

Content

(2) The notification must be provided electronically in a format specified by or acceptable to the Minister and contain the following information:

1. (a) the importer’s name and contact information;
2. (b) the name and contact information of each fabricator, packager/labeller and tester of the designated biocide and the address of each building in which it is fabricated, packaged/labelled or tested;
3. (c) in respect of the designated biocide that is intended to be imported,
   1. (i) its brand name,
   2. (ii) its medicinal ingredients,
   3. (iii) its dosage form,
   4. (iv) its strength,
   5. (v) the types of premises for which its use is recommended, and
   6. (vi) its identifying code or number, if any, assigned in the country in which it is authorized for sale;
4. (d) a detailed description of the designated biocide’s conditions of use;
5. (e) the intended port of entry into Canada;
6. (f) the estimated date of arrival of the shipment of the designated biocide;
7. (g) the customs identification number for the shipment of the designated biocide; and
8. (h) the total quantity of the designated biocide that is intended to be imported.

Accessibility of information

13 An importer of a designated biocide that sells it must ensure that the information referred to in paragraph 12(2)(d) is available

1. (a) in a manner that permits the safe use of the biocide; and
2. (b) in both English and French.

Medical Devices

Definitions

Definitions

14 The following definitions apply in this section and in sections 15 to 18.

List of Medical Devices — Notification of Shortages means the List of Medical Devices — Notification of Shortages that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux — avis de pénuries)

shortage means a situation in which the manufacturer of a medical device is unable to meet the demand for the device or for any component, accessory or part of the device. It does not include a situation in which the manufacturer is also the manufacturer of a substitute medical device, component, accessory or part and is able to meet the demand for it. (pénurie)

specified medical device means a medical device that is set out in the List of Medical Devices — Notification of Shortages or that is part of a category of medical devices that is set out in that List. (instrument médical inscrit)

Shortages — Notification

Shortage — information

15 (1)  Subject to subsection (5), if a shortage of a specified medical device — or of its components, accessories or parts — exists or is likely to occur, the manufacturer and the importer of the device must each provide the following information to the Minister electronically in a format specified by or acceptable to the Minister:

1. (a) the name and contact information of the manufacturer and of the importer;
2. (b) in the case of a Class II, III or IV device in respect of which a medical device licence is issued under the Medical Devices Regulations, the medical device licence number;
3. (c) in the case of a device in respect of which an authorization for importation or sale of the device is issued under another interim order made under section 30.1 of the Food and Drugs Act, the authorization identification number;
4. (d) 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;
5. (e) in both English and French, the name of the device and of any component, accessory or part of the device, including, if applicable, the model name;
6. (f) a description of the device and of its packaging and an indication of whether it is a single-use device;
7. (g) the date when the shortage began or is anticipated to begin; and
8. (h) the anticipated date when the manufacturer will be able to meet the demand for the device if that date can be anticipated.

Timing

(2) Subject to subsection (6), the information must be provided

1. (a) if the manufacturer or importer did not anticipate the shortage, within five business days after the day on which the manufacturer or importer becomes aware of it; and
2. (b) if the manufacturer or importer anticipates that there will be a shortage, within five business days after the day on which the manufacturer or importer anticipates it.

Updates

(3) If any of the information that was provided changes, the manufacturer or importer must provide the new information to the Minister electronically in a format specified by or acceptable to the Minister within two business days after the day on which the manufacturer or importer makes or becomes aware of the change.

End of shortage

(4) Within two business days after the day on which the manufacturer is able to meet the demand for the specified medical device or for its components, accessories or parts, the manufacturer or importer must notify the Minister electronically in a format specified by or acceptable to the Minister of the manufacturer’s ability to do so.

No obligation to provide information

(5) The manufacturer or importer need not provide the information if, within the applicable period referred to in paragraph (2)(a) or (b), the manufacturer or importer anticipates that the manufacturer will be able to meet the demand for the specified medical device or for its components, accessories or parts within 30 days after the day on which the manufacturer or importer anticipated or became aware of the shortage.

Exception

(6) Despite subsection (5), if the manufacturer or importer subsequently concludes that the manufacturer is unable to meet the demand within the 30-day period referred to in that subsection, the manufacturer or the importer must provide the information within five business days after the day on which the manufacturer or importer reaches that conclusion.

Permission

16 (1) Despite subsection 15(1), the manufacturer of a specified medical device may permit the importer of the device to provide the information referred to in that subsection on the manufacturer’s behalf if the information that the manufacturer and importer must provide is identical.

Notification

(2) The manufacturer must notify the Minister electronically in a format specified by or acceptable to the Minister if the manufacturer has permitted the importer to provide the information on the manufacturer’s behalf.

Publication of information

17 (1) The Minister must publish the information that he or she receives under section 15 on the Government of Canada website.

Exception

(2) Subsection (1) does not apply if the Minister has reasonable grounds to believe that a situation, in respect of which information was provided under section 15, does not meet the definition shortage in section 14.

Shortages — Request for Information

Information request

18 (1) The Minister may request that the manufacturer or the importer of a medical device, or any distributor of the device, provide the Minister with information in respect of the device that is in their control if the Minister has reasonable grounds to believe that

1. (a) there is a shortage of the device in Canada or the device is at risk of going into shortage;
2. (b) the information is necessary to establish or assess
   1. (i) the existence of a shortage or risk of shortage of the device,
   2. (ii) the reasons for a shortage or risk of shortage of the device,
   3. (iii) the effects or potential effects on human health of a shortage of the device, or
   4. (iv) measures that could be taken to prevent or alleviate a shortage of the device; and
3. (c) the manufacturer, importer or distributor will not provide the information without a legal obligation to do so.

Obligation to provide information

(2) The manufacturer, importer or distributor must provide the requested information electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister. The time limit cannot be less than 24 hours after the request is made unless the Minister has reasonable grounds to believe that there is a serious and imminent risk of injury to human health.

Restriction

(3) The information that may be requested does not include personal information, as defined in section 3 of the Privacy Act, in respect of a patient or user or any other person whose health or safety may be adversely affected by the shortage of the medical device.

Interpretation

(4) In this section, a reference to a medical device includes its components, accessories and parts.

Exceptional Importation and Sale

Definitions

19 The following definitions apply in this section and in sections 20 to 22.

designated medical device means a medical device that is set out in the List of Medical Devices for Exceptional Importation and Sale or that is part of a category of medical devices that is set out in that List. (instrument médical désigné)

List of Medical Devices for Exceptional Importation and Sale means the List of Medical Devices for Exceptional Importation and Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux destinés aux importations et aux ventes exceptionnelles)

Non-application

20 The provisions of the Medical Devices Regulations — other than sections 44 to 65.1 — do not apply to a medical device if the device is

1. (a) a designated medical device for which no country of manufacture is specified in the List of Medical Devices for Exceptional Importation and Sale; or
2. (b) a designated medical device for which a country of manufacture is specified in the List of Medical Devices for Exceptional Importation and Sale and the device is manufactured in that country.

Notification

21 (1) An importer of a designated medical device must notify the Minister in accordance with subsection (2) not later than the fifth business day before the day on which the device is imported.

Content

(2) The notification must be provided electronically in a format specified by or acceptable to the Minister and contain the following information:

1. (a) the importer’s name and contact information;
2. (b) in respect of the designated medical device that is intended to be imported,
   1. (i) its name and the name of each of its components, parts and accessories, including, if applicable, the model name,
   2. (ii) its identifier, 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,
   3. (iii) the name and contact information of the manufacturer of the device as it appears on the device label, and
   4. (iv) the name and address of the establishment where it is manufactured, if different from the information referred to in subparagraph (iii);
3. (c) a detailed description of the medical conditions, purposes and uses for which the designated medical device is manufactured, sold or represented, as well as the performance specifications of the device if those specifications are necessary for proper use;
4. (d) the intended port of entry into Canada;
5. (e) the estimated date of arrival of the shipment of the designated medical device;
6. (f) the customs identification number for the shipment of the designated medical device; and
7. (g) the total number of units of the designated medical device that are intended to be imported.

Accessibility of information

22 An importer of a designated medical device that sells it must ensure that the information referred to in paragraph 21(2)(c) is available

1. (a) in a manner that permits the safe use of the device; and
2. (b) in both English and French.

Food for a Special Dietary Purpose

Definitions

Definitions

23 The following definitions apply in this section and in sections 24 to 26.

designated food for a special dietary purpose means a food for a special dietary purpose that is set out in the List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale or that is part of a class of foods for a special dietary purpose that is set out in that List. (aliment à des fins diététiques spéciales désigné)

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 a food for a special dietary purpose within its jurisdiction and that may take enforcement action to ensure that such foods marketed within its jurisdiction comply with the applicable legal requirements. (autorité réglementaire étrangère)

List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale means the List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste d’aliments à des fins diététiques spéciales destinés aux importations et aux ventes exceptionnelles)

Exceptional Importation and Sale

Non-application

24 (1) Sections A.01.014 and A.01.016 of the Food and Drug Regulations, the provisions of Part B of those Regulations — other than sections B.24.100 and B.24.300 — and the provisions of Part D of those Regulations do not apply to a food for a special dietary purpose that is imported if the food is

1. (a) a designated food for a special dietary purpose for which no country of manufacture is specified in the List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale; or
2. (b) a designated food for a special dietary purpose for which a country of manufacture is specified in the List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale and the food is manufactured in that country.

Exemptions

(2) A food for a special dietary purpose that is imported and that is referred to in either paragraph (1)(a) or (b) is exempt from the application of paragraphs 4(1)(a) and (d) of the Food and Drugs Act in respect of the use or presence of any of the following substances or materials:

1. (a) food additives;
2. (b) any nutritive material that is used as an ingredient of the food;
3. (c) vitamins, mineral nutrients and amino acids;
4. (d) agricultural chemicals;
5. (e) food packaging materials and components of those materials;
6. (f) drugs recommended for administration to animals that may be consumed as food; and
7. (g) any other substance specified in the List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale in respect of the food.

Notification

25 (1) An importer of a designated food for a special dietary purpose must notify the Minister in accordance with subsection (2) not later than the fifth business day before the day on which the food is imported.

Content

(2) The notification must be provided electronically in a format specified by or acceptable to the Minister and contain the following information:

1. (a) the importer’s name and contact information;
2. (b) information that demonstrates that the sale of the designated food for a special dietary purpose is authorized by a foreign regulatory authority, if such an authorization is required within its jurisdiction;
3. (c) the name and contact information of the manufacturer of the designated food for a special dietary purpose as it appears on that food’s label;
4. (d) the name and address of each establishment in which the designated food for a special dietary purpose is manufactured;
5. (e) in respect of the designated food for a special dietary purpose that is intended to be imported,
   1. (i) a copy of its labels,
   2. (ii) the special dietary purpose for which it is represented,
   3. (iii) a list of its ingredients,
   4. (iv) the warnings, if applicable,
   5. (v) directions for its preparation, use and storage,
   6. (vi) the expiration date, and
   7. (vii) its lot number, if applicable;
6. (f) the intended port of entry into Canada;
7. (g) the estimated date of arrival of the shipment of the designated food for a special dietary purpose;
8. (h) the customs identification number for the shipment of the designated food for a special dietary purpose; and
9. (i) the total quantity of the designated food for a special dietary purpose that is intended to be imported.

Accessibility of information

26 An importer of a designated food for a special dietary purpose that sells it must ensure that the information referred to in subparagraphs 25(2)(e)(ii) to (vii) is available

1. (a) in a manner that permits the safe preparation and use of the food; and
2. (b) in both English and French.

Transitional Provisions

Definitions

27 The following definitions apply in sections 28 to 32.

designated hand sanitizer means a drug as defined in section 2 that

1. (a) is not a pest control product whose use is regulated under the Pest Control Products Act; and
2. (b) is intended to reduce or inactivate micro-organisms on human skin. (désinfectant pour les mains désigné)

Interim Order No. 1 means the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, made by the Minister on March 30, 2020 and published in the Canada Gazette, Part I, on April 11, 2020, as it read immediately before the day on which this Interim Order is made. (arrêté d’urgence n^o 1)

Requests

28 A request made by the Minister under subsection 7(1) of Interim Order No. 1 before the day on which this Interim Order is made is deemed to be a request made under subsection 6(1).

Drugs — six months after Interim Order is made

29 (1) An importer who has notified the Minister under section 9 of Interim Order No. 1 in respect of a designated drug, as defined in section 2, need not comply with paragraph 9(b) in respect of the drug during the six-month period following the day on which this Interim Order is made.

Medical devices — six months after Interim Order is made

(2) An importer who has notified the Minister under section 22 of Interim Order No. 1 in respect of a designated medical device, as defined in section 19, need not comply with paragraph 22(b) in respect of the device during the six-month period following the day on which this Interim Order is made.

Foods — six months after Interim Order is made

(3) An importer who has notified the Minister under section 26 of Interim Order No. 1 in respect of a designated food for a special dietary purpose, as defined in section 23, need not comply with paragraph 26(b) in respect of the food during the six-month period following the day on which this Interim Order is made.

Permission — six-month period

30 (1) Subject to subsection (2), a person who, during the period in which Interim Order No. 1 was in effect, conducted an activity referred to in Table I to section C.01A.008 of the Food and Drug Regulations only in respect of a designated hand sanitizer, without holding an establishment licence that authorized them to do so, may continue to do so until the end of the six-month period that begins on the day on which this Interim Order is made.

Cessation of permission — application filed

(2) If, before the end of the six-month period referred to in subsection (1), the person submits in accordance with section C.01A.005 or C.01A.006 of the Food and Drug Regulations an application to obtain or amend an establishment licence to authorize the activity that they have been conducting in respect of the designated hand sanitizer and the application contains the statements referred to in subsection (3), the person may continue to conduct the activity in respect of the hand sanitizer without holding an establishment licence that authorizes them to do so until

1. (a) the Minister issues or amends the licence to authorize the activity;
2. (b) the Minister notifies the person, after giving them the opportunity to be heard, that the licence will not be issued or amended; or
3. (c) the person withdraws the application.

Statements in application

(3) The application is to include statements indicating that

1. (a) the application is being made to obtain or amend an establishment licence to authorize the activity referred to in subsection (1), which the person has been conducting in respect of the designated hand sanitizer; and
2. (b) the person conducted that activity in respect of the designated hand sanitizer during the period in which Interim Order No. 1 was in effect.

Exception — withdrawal of application

(4) Despite subsection (2), if the person withdraws their application during the six-month period referred to in subsection (1), they may continue to conduct, until the end of that period, the activity in respect of the designated hand sanitizer without holding an establishment licence that authorizes them to do so.

Application for drug identification number

31 Section 12 of Interim Order No. 1 applies in respect of an application for a drug identification number that is for a designated hand sanitizer and that was made under subsection C.01.014.1(1) of the Food and Drug Regulations during the period in which Interim Order No. 1 was in effect.

New drug submission

32 Section 13 of Interim Order No. 1 applies in respect of a new drug submission that is for a designated hand sanitizer and that was filed under subsection C.08.002(2) of the Food and Drug Regulations during the period in which Interim Order No. 1 was in effect.

Repeal

Repeal

33 The Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, made by the Minister of Health on March 30, 2020 and published in the Canada Gazette, Part I, on April 11, 2020, is repealed.