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 ActFootnote b, makes the annexed Interim Order Respecting Epinephrine Auto-injectors.
La ministre de la Santé,
Ginette Petitpas Taylor
Minister of Health
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.
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.
4 The provisions in the Regulations respecting importation do not apply to the importation of epinephrine auto-injectors if
- the epinephrine auto-injectors are imported directly from the United States by a person who holds an establishment licence
- that authorizes the person to import pharmaceuticals in a sterile dosage form, and
- that is not suspended; and
- 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.
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.
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.
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