G/TBT/N/CAN/456  
 
1 July 2015  
(15-3390)  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 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 SPS & TBT 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, wher e applicable): Tampering of 
prescription drugs (ICS: 11.120) 
5. Title, number of pages and langua ge(s) of the notified document: Pre-Consultation 
Notice – Draft Tamper-Resistant Properties of Drugs Regulations (3 pages, in English and French) 
6. Description of content: In order to address risks associated with tampering of 
prescription drugs for abuse purposes, in particular drugs containing controlled substances, 
Health Canada proposes to establish a regulatory framework under the Controlled Drugs 
and Substances Act  (CDSA) which would require certain formulations of drugs to have 
tamper resistant properties before being authorized to be marketed in Canada.  
This Notice, further to the Notice of Intent to  Interested Parties – Tamper Resistance under 
the Controlled Drugs and Substances Act  published in Canada Gazette , Part I on 28 June 
2014, outlines Health Canada's intent with re spect to its regulatory proposal and seeks 
additional input from the public regarding the proposed regulatory framework. Public 
feedback will be considered by the Government  when initiating the regulatory development 
process. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health 
8. Relevant documents: Canada Gazette , Part I, June 28, 2014 – Vol. 148, No.26 (pages 
1620-1622) http://www.gazette.gc.ca/rp-pr/p1/ 2014/2014-06-28/pd f/g1-14826.pdf  G/TBT/N/CAN/456 
 
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  9. Proposed date of adoption: Not stated 
Proposed date of entry into force: The proposed regulations are expected to be 
published in June 2016 and the coming into force of the final regulations is anticipated three 
years after final publication 
10. Final date for comments: 10 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 text can be downloaded at: 
http://www.gazette.gc .ca/rp-pr/p1/2015/201 5-06-27/html/notice -avis-eng.php#ne10  
http://www.gazette.gc .ca/rp-pr/p1/2015/201 5-06-27/html/notice -avis-fra.php#ne10  
http://www.gazette.gc.c a/rp-pr/p1/2015/2015-06 -27/pdf/g1-14926.pdf