G/TBT/N/CAN/588  
 
4 June 2019  
(19-3829) 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:  Department of Health  
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 and Enquiry Point  
Global Affairs Canada  
Technical Barri ers and Regulations Division  
111 Sussex Drive, Ottawa, ON K1A 0G2  
Canada  
Telephone: (343)203 -4273 
Fax: (613)943 -0346 
E-mail: enquirypoint@international.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 – Prescription and Non -prescription; Medical device s products; Veterinary drugs 
(ICS: 11.120, 11.220)  
5. Title, number of pages and language(s) of the notified document:  Fees in Respect 
of Drugs and Medical Devices Order (90 pages, available in English and French) and 
Regulations Amending and Repealing Ce rtain Regulations Made Under the Financial 
Administration Act (8 pages, available in English and French)  
6. Description of content:  Health Canada is embarking on a process to modernize its cost 
recovery regime for health products.  
The Budget Implementation Act, 2017 amended the Food and Drugs Act to provide Health 
Canada with new authorities to establish an agile cost recovery system capable of 
supporting regulatory system delivery and transformation, while maintaining 
transparency and account ability principles.  
Applicable fee regulations under the Financial Administration Act have been repealed and 
new fee regulations are established under the Food and Drugs Act. Health Canada has 
used these new authorities to update and revise existing fees f or human drugs, veterinary 
drugs and medical devices to better reflect costs of program delivery.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The regulations will revise the fee structure and cost recovery framewo rk for 
drugs and medical devices to ensure that Health Canada has an agile modernized system 
that supports effective and responsive service delivery, a fair and consistent approach to G/TBT/N/CAN/588  
 
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  program funding, while at the same time alleviating the costs of regulat ory services on 
Canadian taxpayers.  
8. Relevant documents:   
• Food and Drug Regulations:  
http://laws -lois.justice.gc.ca/eng/regulations/c.r.c.,_c._870/index.html  
(English)  
http://laws -lois.justice.gc.ca/fra/reglements/C.R.C.%2C_ch._870/index.html  
(French)  
• Medical Devices Regulations:  
https://laws -lois.justice.gc.ca/eng/regulations/  sor-98-282/ (English)  
https://laws -lois.justice.gc.ca/fra/reglements/DORS -98-282/ (French)  
•  Canada Gazette , Part II, 29 May 2019, pages 1795 -1884, 1987 -1994 (available 
in English and French)  
9. Proposed date of adoption:  29 May 2019  
Proposed date of entry into force:  1 April 2020  
10. Final date for comments:  Not applicable  
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 proposal can be found at:  
http://gazette.gc.ca/rp -pr/p2/2019/2019 -05-29/html/sor -dors124 -eng.html   
http://gazette.gc.ca/rp -pr/p2/2019/2019 -05-29/html/sor -dors124 -fra.html  
http://gazette.gc.ca/rp -pr/p2/2019/2019 -05-29/html/sor -dors134 -eng.html  
http://gazett e.gc.ca/rp -pr/p2/2019/2019 -05-29/html/sor -dors134 -fra.html