Interim Order Respecting Epinephrine Auto-injectors

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 Epinephrine Auto-injectors.

Ottawa, 2018

La ministre de la Santé,

Ginette Petitpas Taylor
Minister of Health

Interpretation

Definitions

1 The following definitions apply in this Interim Order.

epinephrine auto-injector means the epinephrine auto-injector, 0.15 mg or 0.3 mg dose, that is approved for sale in the United States and identified in that country by the brand name AUVI-Q® (epinephrine injection, USP)‍. (auto-injecteur d’épinéphrine )

import has the same meaning as in subsection C.01A.001‍(1) of the Regulations. (importer)

Regulations means the Food and Drug 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.

Purpose

Importation and sale

3 The purpose of this Interim Order is to permit the immediate importation and sale of epinephrine auto-injectors for use in the emergency treatment of life-threatening reactions in people who are at risk of or have a history of anaphylaxis.

Non-application

Importation

4 The provisions in the Regulations respecting importation do not apply to the importation of epinephrine auto-injectors if

1. the epinephrine auto-injectors are imported directly from the United States by a person who holds an establishment licence
   1. that authorizes the person to import pharmaceuticals in a sterile dosage form, and
   2. that is not suspended; and
2. the lot or batch of epinephrine auto-injectors that is imported is identified by a label that bears the United States National Drug Code (NDC) 60842-022-01 or 60842-023-01.

Sale

5 The provisions in the Regulations respecting sale do not apply to the sale of an epinephrine auto-injector if the package of the epinephrine auto-injector that is sold is identified by a label that bears the NDC 60842-022-01 or 60842-023-01.

Part C of Regulations

6 Subject to sections 8 to 10, the provisions of Part C of the Regulations do not apply in respect of the epinephrine auto-injectors that are referred to in sections 4 and 5.

Requirement — Information Handout

Sale to consumer

7 A person must not sell an epinephrine auto-injector to a consumer unless the epinephrine auto-injector is accompanied by the information handout entitled Patient Information — Auvi-Q® (epinephrine injection) Auto-Injector For Allergic Emergencies (Anaphylaxis), published in 2018 by the Government of Canada on its website.

Application of Certain Provisions of the Regulations

Prohibition — sale

8 (1) Subject to subsection (2), the prohibition set out in section C.01.016 of the Regulations applies to the sale of the epinephrine auto-injectors that are referred to in sections 4 and 5.

Serious adverse drug reaction reporting

(2) The manufacturer of the epinephrine auto-injectors is required to comply only with the requirement set out in section C.01.017 of the Regulations.

Recalls

9 Section C.01.051 of the Regulations applies in respect of the epinephrine auto-injectors that are referred to in sections 4 and 5.

Activities ordered under section 21.32 of Act

10 Section C.01.053 of the Regulations applies in respect of the epinephrine auto-injectors that are referred to in sections 4 and 5.