G/TBT/N/CAN/637  
7 April 2021  
(21-2877) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  English /French  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  CANADA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Health Canada  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
Canada's Notification Authority a nd Enquiry Point  
Technical Barriers and Regulations Division  
Global Affairs Canada  
111 Sussex Drive  
Ottawa, Ontario, K1A 0G2  
Canada  
Telephone: (343)203 -4273 
Fax: (613)943 -0346 
Email: enquirypoint@int ernational.gc.ca  
3. Notified under Article 2.9.2 [   ], 2.10.1 [X], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Drugs; 
Pharmaceutics (ICS 11.120)  
5. Title, number of pages and language(s) of the notified document:  Regulations 
Amending the Food and Drug Regulations (Interim Order Respecting the Importation, 
Sale and Advertising of Drugs for Use in Relation to COVID -19), 51 pages, (available in 
English and French)  
6. Description of content:  In order to address the immediate COVID -19 public health 
emergency the Minister of Health made the Interim Order Respecting the Importation, 
Sale and Advertising of Drugs for Use  in Relation to COVID -19 (Interim Order) on 16 
September 2020. The Interim Order creates flexibilities in the authorization process, 
import and distribution of COVID -19 drugs and is valid for 12 months. Upon expiry, all 
authorizations and licences issued u nder the IO also expire, unless regulations are 
brought into place beforehand to ensure Canadians continue to have uninterrupted access 
to COVID -19 drugs.  
The Regulations  Amending the Food and Drug Regulations (Interim Order Respecting the 
Importation,  Sale and Advertising of Drugs for Use in Relation to COVID -19),introduce 
amendments to the Food and Drug Regulations  (FDR) to  incorporate optional flexibilities, 
related to market authorization, drug establishment licensing, and pre -positioning for 
COVID -19 drugs, that were available under the Interim Order. Furthermore, they allow 
for the continued sale of COVID -19 drugs authorized under the Interim Order.  
These amendments to the FDR:  G/TBT/N/CAN/637  
 
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  • Allow continued and timely access to safe and effective COVID -19 drugs for 
Canadians by normalizing the review, authorization and oversight of COVID -19 
drugs under the FDR;  
• Enable the sale and advertising of COVID -19 drugs that were authorized under 
the Interim Order, not including those generic drugs authorized to alleviate 
shortages, to continue without interruption after the Interim Order ceases to 
have effect;  
• Enable new COVID -19 drugs that had not been authorized under the Interim 
Order, to seek authorization under the FDR with similar flexibilities as had been 
provided u nder the Interim Order;  
• Permit continuity of the post -market regulatory obligations placed on 
authorization holders, manufacturers and importers after expiration of the 
Interim Order;  
• Provide a legal pathway that allows the early importation of a promisin g COVID -
19 drug for placement in Canadian facilities (pre -positioning), for which a 
Government of Canada contract for its procurement is in place, prior to that 
drug receiving market authorization in Canada; and  
• Enable continuity of a flexible approach for  Drug Establishment Licenses (DELs) 
that authorize regulated activities in respect of COVID -19 drugs.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  These amendments to the Food and Drug Regulations  are necessary to 
maintain a mechanism by which COVID -19 drugs are accessible to Canadians throughout 
the ongoing pandemic, while also providing adequate oversight. Furthermore, the 
regulatory agilities introduced in these amendments minimize burden to industry and 
reduce t rade barriers, facilitating trade.; Protection of human health or safety  
8. Relevant documents:   
Health Canada website:  
https://www.canada.ca/en/health -canada/services/drugs -health -produc ts/drug -
products/applications -submissions/guidance -documents/food -drug-regulations -
amendments -covid-19.html  (English)  
https://www.canada.ca/fr/sante -canada/services/medicaments -produits -
sante/medicaments/demandes -presentations/lignes -directrices/reglement -aliments -
drogues -modifications -covid-19.html  (French)  
Canada Gazette , Part II, Volume 155, 31 March 2021, pages 723 to 773 (available in 
English and French):   
https://canadagazette.gc.ca/rp -pr/p2/2021/2021 -03-31/pdf/g2 -15507.pd f 
9. Proposed date of adoption:  31 March 2021 ; On the date of publication  
Proposed date of entry into force:  Some of the amendments to the FDR and 
transitional provisions will come into force upon registration to make the flexibilities 
accorded to COVID -19 drugs available as soon as possible. The remainder of the 
amendments and transitional provisions will come into force on the day that the Interim 
Order ceases to have effect (16 September 2021).  
10. Final date for comments:  Non applicable (These regulations have been granted an 
exemption from publication in Canada Gazette, Part I, and therefore a pre -consultation 
was not conducted.)  G/TBT/N/CAN/637  
 
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  11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
The electronic version of the regulatory text can be found at:  
https://canadagazette.gc.ca/rp -pr/p2/2021/2021 -03-31/html/sor -dors45 -eng.html   
https://canadagazette.gc.ca/rp -pr/p2/2021/2021 -03-31/html/sor -dors45 -fra.html