Canada Gazette, Part I, Volume 153, Number 19: Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies)

May 11, 2019

Statutory authorities
Food and Drugs Act
Patent Act

Sponsoring department
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

For the Regulatory Impact Analysis Statement, see the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment).

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council proposes to make the annexed Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies), pursuant to

• (a) section 30 ^{footnote a} of the Food and Drugs Act ^{footnote b}; and
• (b) sections 12 ^{footnote c} and 134 ^{footnote d} of the Patent Act ^{footnote e}.

Interested persons may make representations concerning the proposed Regulations within 70 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 Bruno Rodrigue, Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Health Canada, Address Indicator 3000A, 11 Holland Avenue, Suite 14, Ottawa, Ontario K1A 0K9 (email: hc.lrm.consultations-mlr.sc@canada.ca).

Ottawa, May 3, 2019

Ima Armani
Acting Assistant Clerk of the Privy Council

Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies)

Food and Drugs Act

Food and Drug Regulations

1 The heading before section C.10.001 of the Food and Drug Regulations^{footnote 1} is replaced by the following:

Urgent Public Health Need — Foreign Approved Drugs

2 (1) The portion of subsection C.10.001(1) of the Regulations before the definition foreign regulatory authority is replaced by the following:

C.10.001 (1) The following definitions apply in this Division.

(2) The definition foreign regulatory authority in subsection C.10.001(1) of the Regulations is replaced by the following:

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 drugs within its jurisdiction and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with the applicable legal requirements. (autorité réglementaire étrangère)

(3) Paragraph (d) of the definition public health official in subsection C.10.001(1) of the Regulations is replaced by the following:

• (d) the Chief Medical Officer of Public Health for the Department of Indigenous Services Canada. (responsable de la santé publique)

(4) Section C.10.001 of the Regulations is amended by adding the following after subsection (1):

(1.1) This Division applies to a drug for human use in dosage form for which a drug identification number has not been assigned under subsection C.01.014.2(1) or for which a notice of compliance has not been issued under section C.08.004 or C.08.004.01.

(5) Paragraph C.10.001(2)(b) of the French version of the Regulations is replaced by the following:

• b) la vente de la drogue est autorisée par une autorité réglementaire étrangère relevant des États-Unis, de la Suisse ou de l’Union européenne pour être utilisée pour le même usage ou aux mêmes fins que ceux visés au sous-alinéa a)(ii);

3 Paragraphs C.10.003(b) and (c) of the French version of the Regulations are replaced by the following:

• b) la marque nominative de la drogue;
• c) les ingrédients médicinaux de celle-ci, sa concentration, sa forme posologique, la voie d’administration et tout code ou numéro d’identification qui lui a été attribué dans le pays où sa vente a été autorisée;

4 Part C of the Regulations is amended by adding the following after Division 10:

DIVISION 11

Public or Canadian Armed Forces Health Emergencies — Drugs for Immediate Use or Stockpiling

C.11.001 The following definitions apply in this Division.

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 drugs within its jurisdiction and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with the applicable legal requirements. (autorité réglementaire étrangère)

public health official means

• (a) the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act;
• (b) the Chief Medical Officer of Health, or equivalent, of a province;
• (c) the Medical Officer of Health, or equivalent, of a municipality;
• (d) the Surgeon General of the Canadian Armed Forces; or
• (e) the Chief Medical Officer of Public Health for the Department of Indigenous Services Canada. (responsable de la santé publique)

C.11.002 This Division applies to a drug for human use in dosage form for which a drug identification number has not been assigned under subsection C.01.014.2(1) or for which a notice of compliance has not been issued under section C.08.004 or C.08.004.01.

C.11.003 (1) In order to address an actual, imminent or potential emergency, event or incident affecting public health or the health of members of the Canadian Armed Forces, a public health official may, upon application to the Minister, obtain an authorization that permits a drug manufacturer to sell to the public health official a specified quantity of a drug for one or both of the following purposes:

• (a) immediate use; or
• (b) stockpiling.

(2) The application must contain the following information and documents:

• (a) the name and contact information of the public health official, so as to allow communication at any time;
• (b) the name and contact information of the manufacturer, so as to allow communication at any time;
• (c) a description of the emergency, event or incident;
• (d) a statement of whether the drug is for immediate use or stockpiling, or both;
• (e) the use of the drug that is intended to address the emergency, event or incident, as the case may be;
• (f) the civic address to which the drug is to be shipped by the manufacturer;
• (g) the following information about the drug:
  • (i) its brand name, if any, and either its proper name, common name and chemical name or its identifying name, code, number or mark,
  • (ii) its medicinal ingredients,
  • (iii) its strength,
  • (iv) its dosage form,
  • (v) the recommended dosage for the use of the drug specified in accordance with paragraph (e),
  • (vi) its recommended route of administration,
  • (vii) the indications that are approved by any foreign regulatory authority, if applicable,
  • (viii) its contraindications, and
  • (ix) a summary of its safety profile;
• (h) the quantity of the drug required to address the emergency, event or incident;
• (i) a statement by the public health official, accompanied by supporting information or documents, attesting to the following:
  • (i) there is an actual, imminent or potential emergency, event or incident affecting public health or the health of the members of the Canadian Armed Forces, that is likely to result, in humans, in a disease, disorder or abnormal physical state that is serious or life-threatening,
  • (ii) immediate action is or would likely be required to diagnose, treat, mitigate or prevent the disease, disorder or abnormal physical state, or its symptoms,
  • (iii) conventional therapies, if any, have failed, are unsuitable or are unavailable in Canada when the application is made, and
  • (iv) the known and potential benefits associated with the use of the drug specified in accordance with paragraph (e) outweigh the known and potential risks associated with that use;
• (j) any information or documents available to the public health official concerning the use, safety, efficacy and quality of the drug for the use specified in accordance with paragraph (e), including information published in a medical or scientific journal; and
• (k) the following information, if known by the public health official:
  • (i) the names of the foreign regulatory authorities that have authorized the sale of the drug in their jurisdictions for the same use specified in accordance with paragraph (e),
  • (ii) the names of the foreign regulatory authorities that have received an application for authorization to sell the drug in their jurisdictions for the use specified in accordance with paragraph (e), but that have not yet made their decision when the application is made, and
  • (iii) the names of the foreign regulatory authorities that have refused to authorize the sale of the drug in their jurisdictions for any use, as well as the reason for the refusal.

(3) The public health official must provide to the Minister any additional information or documents that the Minister requires for the purpose of reviewing the application, by the date specified by the Minister.

C.11.004 (1) The Minister may, upon review of the application, issue an authorization that permits a manufacturer to sell to the public health official a specified quantity of the drug for the purpose specified in the application.

(2) In reviewing an application that is submitted for the purpose of stockpiling, the Minister must consider the following:

• (a) whether there is an alternative mechanism that would address the emergency, event or incident; or
• (b) whether there is an existing stockpile of the drug in Canada in a sufficient quantity to address the emergency, event or incident.

(3) The authorization must contain the following information:

• (a) the date of issue of the authorization;
• (b) the name and contact information of the public health official;
• (c) the name and contact information of the manufacturer;
• (d) a statement of the emergency, event or incident;
• (e) a statement of whether the drug is for immediate use or stockpiling, or both;
• (f) the use of the drug that is authorized to address the emergency, event or incident;
• (g) the civic address where the drug is to be shipped by the manufacturer;
• (h) the following information about the drug:
  • (i) its brand name, if any, and either its proper name, common name and chemical name or its identifying name, code, number or mark,
  • (ii) its medicinal ingredients,
  • (iii) its strength,
  • (iv) its dosage form, and
  • (v) its recommended route of administration; and
• (i) the quantity of the drug that may be sold.

C.11.005 The quantity of the drug that is sold under an authorization is exempt from the provisions of these Regulations, with the exception of the provisions in Part A and this Division.

C.11.006 (1) If the authorization is for immediate use, the public health official must make available the following information, in writing, in English and French:

• (a) to the persons to whom the drug is administered and to the persons who are administering the drug, the known and potential benefits and risks associated with the use of the drug for which the sale of the drug is authorized, as well as the recommended duration of use, if any, of the drug; and
• (b) to the persons who are administering the drug, the information referred to in paragraphs C.11.004(3)(b), (c), (f) and (h).

(2) If the public health official becomes aware of a change to any of the information referred to in subsection (1), the public health official must, in writing and without delay, notify the relevant persons.

C.11.007 (1) If the authorization is for stockpiling, the public health official, and any other person who obtains the authorized quantity, or a portion of the quantity, of the drug, must ensure that, before stockpiling, the drug bears a label or is accompanied by a package insert that clearly sets out the following information in English and French:

• (a) the name and civic address of the manufacturer of the drug;
• (b) a statement that the Minister has authorized the sale of the drug to address the emergency, event or incident specified in the authorization;
• (c) a statement that the drug is to be used only for the use specified in the authorization;
• (d) the brand name of the drug, if any, and either its proper name, common name and chemical name or its identifying name, code, number or mark;
• (e) the medicinal ingredients contained in the drug;
• (f) the strength of the drug;
• (g) the dosage form of the drug;
• (h) the recommended dosage and route of administration of the drug;
• (i) the lot number of the drug, if known;
• (j) all warnings and precautions in respect of the use of the drug, if any;
• (k) the expiration date of the drug, or, if there is no expiration date, the stability testing date or the date upon which it should be retested, as specified by the manufacturer;
• (l) the recommended storage conditions for the drug; and
• (m) a statement of the net contents of the container of the drug, in terms of weight, measure or number.

(2) If the public health official becomes aware of new information in respect of the safety of the drug, or of a change to any of the information referred to in paragraphs (1)(a), (h), (j) or (k), the public health official must

• (a) ensure that the information on the label of the drug or contained in the accompanying package insert is updated, in the case of a drug that is stockpiled by the public health official; or
• (b) notify, in writing and without delay, any person to whom he or she has sold a quantity of the drug for the purpose of stockpiling.

(3) Any person who is notified under paragraph (2)(b) must ensure that the information on the label of the drug or contained in the accompanying package insert is updated.

C.11.008 The public health official must notify the Minister and the manufacturer of the drug, in the following manner and within the following times, of any serious adverse drug reaction to the drug, specifying the nature of the reaction, the lot number involved, the circumstances and any corrective action taken:

• (a) if the reaction is fatal or life-threatening, by notice given within 24 hours after the time at which the public health official becomes aware of the reaction, followed by a written report given within the next 24 hours; and
• (b) in any other case, by a written report given within 15 days after the day on which the public health official becomes aware of the reaction.

C.11.009 (1) One year after the day on which the quantity of the drug obtained under the authorization is used for the first time, and annually thereafter until that quantity is depleted, the public health official must submit a written report to the Minister on the results of the use of the drug during that year, including the number of patients treated and the response of patients to treatment.

(2) The public health official must provide the Minister, in writing, with any new information concerning the safety, efficacy or quality of the drug for the authorized use, within 30 days after becoming aware of it.

C.11.010 The public health official must keep all information about the sale and use of the drug in a way that allows

• (a) submission of the information, notices and reports referred to in sections C.11.008 and C.11.009; and
• (b) communication with persons who have been administered the drug, if their health may be endangered by its use.

C.11.011 The public health official must keep the information, notices and reports referred to in sections C.11.008 to C.11.010 until the expiry of 25 years after the end of the year to which the information, notices and reports relate.

C.11.012 The public health official must submit an annual report to the Minister setting out the unused quantity of stockpiled drug.

C.11.013 (1) The Minister may cancel an authorization if he or she has reasonable grounds to believe that the drug presents a serious or imminent risk of injury to human health.

(2) If an authorization is cancelled, these Regulations apply to any unused quantity of the drug, on the day that the cancellation is effective.

Natural Health Products Regulations

5 Section 103.1 of the Natural Health Products Regulations ^{footnote 2} is renumbered as subsection 103.1(1) and is amended by adding the following after subsection (1):

(2) Division 11 of the Food and Drug Regulations applies in respect of natural health products except that

• (a) the expression “a drug identification number has not been assigned under subsection C.01.014.2(1)” in section C.11.002 is to be read as a reference to “a product number has not been assigned under subsection 8(1) of the Natural Health Products Regulations”; and
• (b) the expression “a notice of compliance has not been issued under section C.08.004 or C.08.004.01” in section C.11.002 is to be read as “a product licence has not been issued under section 7 of the Natural Health Products Regulations”.

Patent Act

Certificate of Supplementary Protection Regulations

6 Subsection 1(2) of the Certificate of Supplementary Protection Regulations ^{footnote 3} is replaced by the following:

Definition of authorization for sale

(2) In these Regulations and for the purposes of section 104 of the Act, authorization for sale means an authorization under the Food and Drugs Act, or any predecessor enactment relating to the same subject-matter, that permits the sale of a drug in Canada, but does not include an interim order permitting the sale of a drug under section 30.1 of that Act, a certificate issued under section C.08.015 of the Food and Drug Regulations, an exemption permitting the sale of a drug under subsection C.10.002(1) of those Regulations, an authorization under section C.05.006, C.05.008, C.08.010 or C.11.004 of those Regulations or section 67 or 71 of the Natural Health Products Regulations.

Coming into Force

7 (1) These Regulations, except section 5, come into force on the day on which they are registered.

(2) Section 5 comes into force on the day after the day on which the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) come into force.