G/TBT/N/CAN/452  
 
24 June 2015  
(15-3264)  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 telephon e 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 
Foreign Affairs, Trade and Development Canada 
Technical Barriers and Regulations Division (TIB) 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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Human drugs and 
biologics (ICS: 11.120) 
5. Title, number of pages and language(s) of the notified document: Regulations 
amending the Food and Drug Regulations (Shortages and Discontinuation of Sale of Drugs) (19 pages, in English and French) 
6. Description of content: The proposed amendments to the Food and Drug Regulations 
would introduce a mandatory drug shortage and discontinuation reporting system which 
would provide patients, practitioners, and other healthcare stakeholders with reliable and 
trustworthy information in a timely fashion, as well as a more accurate picture of which drugs are actively being sold on the Canadian market. This new mandatory reporting 
system would replace the voluntary reporting system that is currently in place.  
The proposed amendments would mandate reporting of drug shortages and 
discontinuations by authorization holders to a third-party website for certain categories of 
drugs that have the potential, in a shortage or discontinuation situation, to adversely affect 
the health of Canadians and the health system. These are drugs in the following 
categories: drugs included in Schedules I to V of the Controlled Drugs and Substances Act; drugs listed on the Prescription Drug List; biologic drugs listed on Schedule D to the Act; 
radiopharmaceutical drugs listed on Schedule C to the Act; and drugs that are permitted to 
be sold without a prescription, but administered only under the supervision of a practitioner. The proposed amendments woul d specify all mandatory information to be 
reported to the website, the timelines for providing it, a requirement that the 
information must be kept up to date, and a requirement that the resolution of a drug 
shortage also be reported. G/TBT/N/CAN/452 
 
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  A new provision would also be added to require authorization holders to notify Health 
C a n a d a  i f  a  d r u g  h a s  n o t  b e e n  s o l d  o n  t h e  C a n a d i a n  m a r k e t  f o r  a  p e r i o d  o f  t w e l v e  consecutive months. This requirement would apply to all drugs that have a drug 
identification number (DIN). It would not affect the license status of the drug, but would 
provide an accurate picture of drugs that are available on the Canadian market. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
The objective of this regulatory proposal is to establish a mandatory requirement to report anticipated or actual shortages or discontinuations for the categories of drugs specified in 
the regulation. 
8. Relevant documents: Food and Drug Regulations: 
http://laws-lois.justice.gc.ca/eng/r egulations/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)  
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 
occur within 12 months following publication in Canada Gazette, Part I 
Proposed date of entry into force: These Regulations come into force six months after 
the day on which they are registered 
10. Final date for comments: 3 September 2015 
11. Texts available from: Nati onal 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://www.gazette.gc.c a/rp-pr/p1/2015/2015-06 -20/html/reg2-eng.php  
http://www.gazette.gc.c a/rp-pr/p1/2015/2015-06 -20/html/reg2-fra.php  
http://www.gazette.gc.c a/rp-pr/p1/2015/2015-06 -20/pdf/g1-14925.pdf