In response to the covid-19 pandemic, the minister of health made interim orders pursuant to the Food and Drugs Act to address the significant risk to health posed by shortages in 2020 and 2021 (for further details, see "Regulatory amendments provide permanent measures to address therapeutic product shortages"). In anticipation of the expiry of Interim Order No. 2, the Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) (the Regulations) were promulgated in 2021, with some provisions set to come into force later. Health Canada has issued a notice regarding the Regulations, which includes an explanation of how the amendments differ from the previous, now-expired, interim orders.
On 2 March 2022, provisions of the Regulations regarding the following subjects, among others, came into force:
- exceptional import and sale of drugs and medical devices;
- amendment to the Certificate of Supplementary Protection Regulations (to carve out from the definition of "authorisation for sale" permission to sell a drug under the Regulations); and
- mandatory reporting of shortages and discontinuations of specified medical devices and the power to compel information on medical device shortages.
Health Canada has announced a new guidance for drugs: Guide to the exceptional importation and sale of drugs in response to drug shortages (GUI-0148). All products on the List of drugs for exceptional importation and sale, including existing products, will now have an end of import date, but are allowed to be sold in Canada until the product expires.
Health Canada has also released related guidance documents for medical devices:
- Guide to reporting medical device shortages and discontinuations; and
- Guidance for exceptional importation and sale of medical devices.
Additionally, on 21 February 2022, Health Canada made a further interim order regarding medical devices: Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (for further details, see "Health Canada facilitates availability of COVID-19 health products").
For further information on this topic please contact Urszula Wojtyra at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.