G/TBT/N/CAN/644  
17 June 2021  
(21-4959) Page: 1/2 
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  
Tel: (343)203 -4273 
Fax: (613)943 -0346 
Email: enquirypoint@internatio nal.gc.ca   
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 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):  Drug 
Products - Pharmaceutics; Pharmaceutics (ICS 11.120)  
5. Title, number of pages and language(s) of the notified document:  Proposed 
Regulations Amending the Food and Drug Regulations (Exports and Transhipments of 
Drugs); (25 pages, available in French  and English).  
6. Description of content:  The proposed amendments to the Food and Drug Regulations  
would apply regulatory requirements to drugs manufactured in Canada solely for export 
that are otherwise exempt from the application of the Food and Drugs A ct and the Food 
and Drug Regulations  under section 37 of the Food and Drugs Act . Manufacturers, 
packagers/labellers, testers, distributors and wholesalers of drugs solely for export would 
be required to hold a drug establishment licence and comply with goo d manufacturing 
practices. The proposed amendments would also clarify that drugs transhipped through 
Canada must be in bond.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objectives of this proposal are to impro ve oversight of drugs 
manufactured, packaged/labelled, tested, distributed or wholesaled in Canada solely for 
export and align Canadian regulation of exported drugs with that of international partners. 
The proposed regulations also aim to clarify requireme nts respecting drugs transhipped 
through Canada.; Other  G/TBT/N/CAN/644  
 
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  8. Relevant documents:   
Canada Gazette , Part I, Volume 155, 12 June 2021, pages 2758 -2782 (available in English 
and French)  : https://canadagazette.gc.ca/rp -pr/p1/2021/2021 -06-12/pdf/g1 -
15524.pdf    
9. Proposed date of adoption:  The day that is six months after the day these regulations 
are published in the Canada Gazette, Part II.  
Proposed date of entry into force:  These regulations would come into force six months 
after the day they are published in the Canada Gazette, Part II. An additional transition 
period of three months would allow a person who conducts a licensable activity with a 
drug solely for export to submit an application for a drug establishment licence and come 
into complian ce with the regulations.  
10. Final date for comments:  26 August 2021  
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 texts can be found at:  
https://canadagazette.gc.ca/rp -pr/p1/2021/2021 -06-12/html/reg3 -eng.html  
https://canadagazette.gc.ca/rp -pr/p1/2021/2021 -06-12/html/reg3 -fra.html