WORLD TRADE
G/TBT/N/CAN/174
30 August 2006
ORGANIZATION
(06-4133)
Committee on Technical Barriers to Trade
Original: English/
French
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1.
Member to Agreement notifying: CANADA
If applicable, name of local government involved (Articles 3.2 and 7.2):
2.
Agency responsible: Department of Health
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:
Canadian Enquiry Point
200-270 Albert Street
Ottawa, Ontario
Canada, K1P 6N7
Tel.:
Fax.:
E-mail:
(+1 613) 238 3222
(+1 613) 569 7808
info@scc.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): Prescription status of
medicinal ingredients for veterinary use (ICS: 11.220)
5.
Title, number of pages and language(s) of the notified document: Proposed Amendment
to the Food and Drug Regulations (Project No. 1478 — Schedule F) (Available in English
and French, 3 pages)
6.
Description of content: This notification announces the availability of a letter that
provides an opportunity to comment on the proposed addition of resocortol and its
derivatives to Part I of Schedule F to the Food and Drug Regulations.
Description of the medicinal ingredient:
Resocortol and its derivatives - is a corticosteroid that is used topically in veterinary
medicine for the treatment of pyotraumatic dermatitis ("Hot Spots") in dogs. Resocortol
butyrate should be used only under the supervision of a veterinarian since professional
veterinary expertise is required to diagnose and treat pyotraumatic dermatitis. This
medicinal ingredient also possesses the potential for undesirable side effects at normal
therapeutic dosage levels, further reinforcing the need for veterinary supervision.
. /.
G/TBT/N/CAN/174
Page 2
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides
with the risk factors associated with this medicinal ingredient. Oversight by a veterinarian is
necessary to ensure that adequate risk/benefit information is considered before the drug
containing the medicinal ingredient is administered and that the drug therapy is properly
monitored.
Schedule F is a list of medicinal ingredients, the sale of which is controlled under sections
C.01.041 to C.01.049 of the Food and Drug Regulations. Part I of Schedule F lists
ingredients that require a prescription for human use and for veterinary use. Part II of
Schedule F lists ingredients that require a prescription for human use, but do not require a
prescription for veterinary use if so labelled or if in a form unsuitable for human use.
7.
Objective and rationale, including the nature of urgent problems where applicable:
Protection of animal health
8.
Relevant documents: Therapeutic Products Directorate (TPD) web site
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-avis/index_e.html
Project No. 1478, letter posted: 18 August 2006
9.
Proposed date of adoption: Normally within 6 to 8 months from the posting of the letter
on the TPD web site.
Proposed date of entry into force: On the date the measure is adopted.
10.
Final date for comments: 1 November 2006
11.
Texts available from: National enquiry point [ X ] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body: The electronic
version of Project No. 1478 can be downloaded at:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/noticeavis/project_projet_1478_e.html