Part IPublic NoticePublished: April 11, 2020

Interim Order on COVID-19 Supplies; Agri‑food Dates

Canada Gazette, Part I, Volume 154, Number 15: GOVERNMENT NOTICES

The Gazette published two government notices: an Interim Order from Health Canada (March 30, 2020) that temporarily allows exceptional importation and, in limited cases, sale of certain drugs, medical devices and foods for special dietary purposes to address COVID‑19 related shortages; and amended ministerial instructions setting the agri‑food immigration instructions' effective period. The Interim Order also creates mandatory short‑age reporting for specified medical devices, requires five‑day pre‑import notification for eligible products, and expedites some authorizations for biocide drugs such as hand sanitizers and disinfectants.

Published
April 11, 2020
Department
Unavailable
Section
DEPARTMENT OF CITIZENSHIP AND IMMIGRATION
Comment deadline
Unavailable
Effective date
March 30, 2020
Publication part
Part I

Summary

Summary#

  • The Canada Gazette published two government notices from late March 2020. One updates the timing for the agri‑food immigration instructions. The other is an interim order from Health Canada called the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (made March 30, 2020) that temporarily changes rules to address shortages tied to the COVID‑19 pandemic.
  • The interim order lets Canada speed up access to certain drugs, medical devices, and special‑diet foods by allowing exceptional importation and sale when domestic supplies are short.

What it does#

  • Ministerial Instructions Amending the Ministerial Instructions Respecting the Agri-food Immigration Class:

    • Sets the effective period for those immigration instructions from May 15, 2020 to May 14, 2023. (This is a timing/administrative update.)
  • Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (Health Canada):

    • Allows the exceptional importation and, in limited cases, sale of certain drugs, medical devices, and foods for special dietary purposes that do not fully meet Canadian regulatory requirements but are manufactured to comparable standards.
    • Creates and maintains government lists (on a Health Canada website) of products and categories eligible for this exceptional pathway.
    • Requires importers to notify the Minister at least five days before importing an eligible product and to provide specified information about the shipment and manufacturer.
    • Requires manufacturers and importers of certain medical devices to report a shortage or an anticipated shortage within five days, and to update changes within two days; they must also notify the Minister within two days when the shortage ends.
    • Eases some application and licensing requirements to speed up approval and availability of biocide drugs (for example, hard surface disinfectants and hand sanitizers). It removes the need for an establishment licence for persons doing only biocide activities, while keeping basic good‑manufacturing rules in place.

Who's affected#

  • Manufacturers and importers of:
    • drugs (including hand sanitizers and hard surface disinfectants),
    • medical devices (for example, personal protective equipment such as masks and gowns),
    • foods for special dietary purposes (for example, infant formula).
  • Health‑care providers, hospitals, distributors, group purchasing organizations, and provincial/territorial authorities involved in sourcing these products.
  • Consumers who rely on these products (patients needing medical devices, people needing special‑diet foods, or the public seeking disinfectants and sanitizers).
  • The changes to the agri‑food immigration instructions primarily affect people and employers involved in the agri‑food immigration class (the notice sets the instruction’s effective dates).

Why it matters#

  • These measures were introduced because of shortages and supply‑chain disruptions tied to the COVID‑19 pandemic. They let Canada bring in needed supplies faster from trusted foreign sources when domestic or usual suppliers cannot meet demand.
  • The new reporting rules for medical‑device shortages give the government earlier visibility into supply problems. That can help prioritize which products to allow in under the exceptional import route.
  • Faster access to products like sanitizers, disinfectants, masks, medical devices, and infant formula can directly affect patient care and public health during the pandemic. At the same time, some products may not meet all normal Canadian regulatory requirements, though Health Canada limits this to situations where comparable standards are met and retains certain safety reporting and quality rules.

Key topics

Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19Food and Drugs ActFood and Drug RegulationsMedical Devices RegulationsList of Medical Devices — Notification of ShortagesList of Drugs for Exceptional Importation and Salebiocide drugshand sanitizershard surface disinfectantsmedical device shortage reportingMinisterial Instructions Respecting the Agri-food Immigration ClassImmigration and Refugee Protection ActIRPADepartment of Citizenship and ImmigrationHealth Canada

Source: Canada Gazette

Official source