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

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:

(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:

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

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

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:

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

(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:

(3) The authorization must contain the following information:

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:

(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:

(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

(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:

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

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

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.