G/TBT/N/CAN/484  
 
9 March 2016  
(16-1373)  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 : 
Canadas Notification Authority and Enquiry Point 
Global Affairs Canada 
Technical Barriers and Regulations Division (TIB) 111 Sussex Drive Ottawa, ON K1A 0G2 
Canada 
Telephone: (343)203-4273 Fax: (613)943-0346 
Email: 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): Methylphenidate, its 
salts, isomers, derivatives and analogues, as well as salts of the derivatives, isomers and 
analogues (ICS: 11.120) 
5. Title, number of pages and language(s) of the notified document: Notice to 
interested parties – Proposal regarding the scheduling of methylphenidate under the 
Controlled Drugs and Substances Act and its regulations (2 pages, available in English and French) 
6. Description of content: Methylphenidate is a stimulant currently listed with its salts in 
Schedule III to the Controlled Drugs and Substances Act  (CDSA). While methylphenidate 
has some abuse potential, methylphenidate is also used in the treatment of Attention 
Deficit Hyperactivity Disorder (ADHD) and narcolepsy. In recent years, there has been a significant increase in the emergence of new psychoactive substances which mimic the 
effects of controlled substances but which are created to circumvent existing drug 
legislation. Several substances related to methylphenidate have been identified as new psychoactive substances with similar effects to methylphenidate, but with no approved therapeutic uses. Health Canada is proposing to amend Schedule III to the CDSA by 
expanding the listing of methylphenidate and its salts to include its derivatives, isomers, 
and analogues, as well as salts of the derivati ves, isomers and analogues. Activities with 
methylphenidate and its salts are authorized under Part G to the FDR, where they are 
scheduled as controlled drugs. However, as the derivatives, isomers and analogues of 
methylphenidate (as well as salts of derivatives, isomers and analogues) have no approved therapeutic uses, Health Canada is proposing to list them under Part J to the FDR. 
Research or scientific use of these substances could be authorized under Part J of the FDR.  G/TBT/N/CAN/484 
 
- 2 - 
 
  7. Objective and rationale, including the nature of urgent problems where 
applicable: The purpose of these amendments is to protect public health and public safety 
8. Relevant documents: Canada Gazette , Part I, 27 February 2016 (available in English and 
French) 
9. Proposed date of adoption: Anticipated for Fall 2016 
Proposed date of entry into force: On the date the regulations are adopted   
10. Final date for comments: 27 April 2016 
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 this Notice can be downloaded at: http://www.gazette.gc.c a/rp-pr/p1/2016/2016-02 -27/pdf/g1-15009.pdf 
http://www.gazette.gc .ca/rp-pr/p1/2016/201 6-02-27/html/notice -avis-eng.php#nb14   
http://www.gazette.gc .ca/rp-pr/p1/2016/201 6-02-27/html/notice -avis-fra.php#nb3