G/TBT/N/CAN/581  
 
2 April 2019  
(19-2067) 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 (ICS: 11.120)  
5. Title, number of pages and langua ge(s) of the notified document:  Regulations 
amending the Food and Drug Regulations (Improving Access to Generics) (24 pages, 
available in English and French).  
6. Description of content:  The regulatory proposal seeks to address cases where generic 
drug pro ducts sometimes differ from their Canadian Reference Product (CRP) (e.g., a 
different salt, hydrate, or solvate of the medicinal ingredient), leading to difficulties in 
determining whether drugs could or could not be approved via the Abbreviated New Drug 
Submission (ANDS) pathway. In certain cases, in both generic and brand name drugs, it 
is possible that there is a change in the form of a medicinal ingredient during 
manufacturing of a drug. This type of change is referred to as an “in -situ change.” In such  
cases, the form of the medicinal ingredient in the dosage form is different from the form 
of the “input ingredient” used in the manufacturing process (the active pharmaceutical 
ingredient). The regulatory proposal also suggests consequential changes to en sure the 
definition of   ‘new active substance’ remains aligned with the definition of ‘innovative 
drug’; and, the definition of ”new active substance” in the Fees in Respect of Drugs and 
Medical Devices Regulations remains aligned with the definition of “i nnovative drug” in 
the Food and Drug Regulations (FDR).  G/TBT/N/CAN/581  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objectives of the proposed regulations include the following:  
• to improve the access to safe, effective and high quality generic medicines by 
ensuring that the FDR reflect evolving science and regulatory decision making 
with respect to what Health Canada considers may be acceptable as an ANDS and 
for which a declaration of equivalence may be issued by clarifying  regulatory 
requirements under the ANDS pathway for generic drug products that contain 
different forms (e.g., different salt forms) of the medicinal ingredient in 
comparison to the CRP, and   
• to create greater consistency and transparency with respect to th e labelling and 
the identification of the medicinal ingredient for drugs approved under Part C, 
Division 8 of the FDR by codifying Health Canada’s position that the labelling 
should declare the medicinal ingredient in the dosage form.  
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)  
Canada Gazette , Part I, 30 March 2019, Pages 1283 -1306 (available in English and 
French)  
9. Proposed date of adoption:  On the date the amendments are registered, notification 
of registration will occur through publication in Canada Gazette, Part II, which is 
anticipated to be 18 months following publication in Canada Gazette, Part I.  
Proposed date of entry into force:  It is proposed these Regulations would come into 
force 90 days after the day on which they are published in the Canada Gazette, Part II.  
As a transitional provision, the proposed amended definition of "innovative drug" wil l not 
apply to a drug where the New Drug Submission (NDS) or Extraordinary Use New Drug 
Submission (EUNDS) was filed before the coming into force. Instead, the version of the 
"innovative drug" definition that was in effect at the time a NDS or EUNDS was fi led by 
the innovator is the version that applies for an "innovative drug".  
10. Final date for comments:  7 June 2019  
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 downloaded at:  
http://gazette.gc.ca/rp -pr/p1/2019/2019 -03-30/html/reg2 -eng.html  
http://gazette.gc.ca/rp -pr/p1/2019/2019 -03-30/html/reg2 -fra.html