G/TBT/N/CAN/435
11 December 2014 
(14-7223)  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 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): Prescription status of 
medicinal ingredients for human use (ICS: 11.120; HS: 3004.90) 
5. Title, number of pages and language(s) of the notified document: Notice of 
Consultation- Prescription Drug List (PDL): Mometasone Furoate Monohydrate (2 pages, in 
English and French) 
6. Description of content: The purpose of this Notice of Consultation is to provide an 
opportunity to comment on the proposal to revise the listing for Adrenocortical hormones 
on the Prescription Drug List (PDL) to allow the nonprescription use of Mometasone furoate monohydrate for the conditions listed below. Only the human part of the PDL is proposed 
to be revised. The proposed wording of the new listing is:  
Drugs containing the following: Adrenocortical hormones or their salts or derivatives Including (but not limited to): Hydrocortisone, Hydrocortisone acetate, Hydrocortisone 
valerate, Hydrocortisone sodium succinate, Clobetasone butyrate, Difluprednate and 
Mometasone furoate monohydrate 
Qualifier: Mometasone furoate monohydrate for the treatment of allergic rhinitis in a nasal 
spray that delivers 50 micrograms (mcg)/spray for those 12 years of age and older. 
If all comments not in favour of this change can be addressed, a Notice of Intent to Amend 
will be posted on the Health Canada website. This Notice will address these comments and inform stakeholders of Health Cana da's intention to revise the PDL. G/TBT/N/CAN/435 
 
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  7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of human health or safety  
8. Relevant documents:  Health Canada website: http://www.hc-sc.gc.ca/dhp-
mps/prodpharma/pdl-ord/notice-avis-eng.php posted on 27 November 2014 (available in 
English and French) 
9. Proposed date of adoption:   9 February 2015 
Proposed date of entry into force:   9 August 2015    
10. Final date for comments: 9 February 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 Notice of Consultation can be downloaded at:  http://www.hc-sc.gc.ca/dh p-mps/consultation/drug-
medic/pdl_ldo_consult_mometasone_furoate_mono-eng.php   
http://www.hc-sc.gc.ca/dh p-mps/consultation/drug-
medic/pdl_ldo_consult_mometasone_furoate_mono-fra.php