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WORLD TRADE
G/TBT/N/CAN/217
29 October 2007
ORGANIZATION
(07-4673)
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.: (+1) 61 3238 3222
Fax.: (+1) 61 3569 7808
E-mail: [email protected]
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. 1530 - Schedule F) (3 pages, available in
English and French).
6.
Description of content:
This notification announces the availability of a letter that provides an opportunity to
comment on the proposed addition of two medicinal ingredients to Part I of Schedule F to
the Food and Drug Regulations.
Description of the medicinal ingredients:
- Pimobendan is a cardiovascular drug for use in dogs. It is indicated for the treatment
of congestive heart failure associated with a weakened heart and heart valves. Direct
supervision by a veterinarian is required to diagnose congestive heart failure and
identify the underlying disease. The animal may also require treatment with other drugs.
Pimobendan is known to have undesirable or severe side effects at normal therapeutic
dosage levels.
. /.
G/TBT/N/CAN/217
Page 2
- Pirlimycin and its salts is an antimicrobial indicated for the treatment of mammary
gland infection in lactating dairy cows caused by the bacteria, Staphylococcus aureus.
Diagnosis by a veterinarian is required prior to use because pirlimycin and its salts
should not be used in animals with mastitis caused by other bacterial strains.
Individualized instruction by a veterinarian is required to demonstrate the correct use of
the drug because incorrect use may result in more severe mastitis.
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides
with the risk factors associated with each medicinal ingredient. Oversight by a veterinarian
is necessary to ensure that appropriate 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) website:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-avis/index_e.html,
Project No. 1530, letter posted: 3 October 2007.
9.
Proposed date of adoption:
Normally within 6 to 8 months from the
posting of the letter on the TPD website.
Proposed date of entry into force:
On the date the measure is adopted.
10.
Final date for comments: 17 December 2007
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. 1530 can be downloaded at:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/noticeavis/project_projet_1530_e.html