Interim Order Respecting Naloxone Hydrochloride Nasal Spray

Interpretation

Definitions

1 The following definitions apply in this Interim Order.

naloxone hydrochloride nasal spray means the drug naloxone hydrochloride nasal spray 4 mg that is approved for sale in the United States and identified in that country by the brand name NARCAN® Nasal Spray. (vaporisateur nasal de chlorhydrate de naloxone)

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, including the distribution, of naloxone hydrochloride nasal spray for use in the emergency treatment of known or suspected opiod overdose.

Non-application

Importation

4 The provisions in the Regulations respecting importation do not apply to the importation of naloxone hydrochloride nasal spray if

1. the spray is imported directly from the United States;
2. the lot or batch of the spray that is imported is identified by a label that bears the United States National Drug Code (NDC) 69547-353-02; and
3. each package of the spray is accompanied by a label that includes instructions for use of the spray and that is approved by the U.S. Food and Drug Administration.

Sale

5 The provisions in the Regulations respecting sale and distribution do not apply to the sale or distribution of naloxone hydrochloride nasal spray if each package of the spray that is sold or distributed is identified by a label that bears the NDC 69547-353-02 and if the package is accompanied by the label referred to in paragraph 4(c), by the French version of that label, published by the Minister of Health, and by the document Important Supplementary Information for NARCAN® Nasal Spray 4 mg, published in 2016 by the Minister of Health, in English and French.

Part C of Regulations

6 Subject to sections 7 and 8, the provisions of Part C of the Regulations do not apply in respect of the naloxone hydrochloride nasal spray that is referred to in sections 4 and 5.

Application of Certain Provisions of the Regulations

Prohibition – sale

7 (1) Subject to subsection (2), the prohibition set out in section C.01.016 of the Regulations applies to the sale of the naloxone hydrochloride nasal spray that is referred to in sections 4 and 5.

Serious adverse drug reaction reporting

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

Recalls

8 Section C.01.051 of the Regulations applies in respect of the naloxone hydrochloride nasal spray that is referred to in sections 4 and 5.