WORLD TRADE
G/TBT/N/CAN/218
29 October 2007
ORGANIZATION
(07-4674)
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: enquirypoint@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 human use (ICS: 11.120).
5.
Title, number of pages and language(s) of the notified document: Proposed Amendment
to the Food and Drug Regulations (Project No. 1540 - Schedule F) (4 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 five medicinal ingredients to Part I of Schedule F to
the Food and Drug Regulations.
Description of the medicinal ingredients:
- Dasatinib is indicated for the treatment of adults with chronic myeloid leukemia
(CML) who are no longer benefitting from other available therapies for CML. Dasatinib
should be given under the supervision of a practitioner experienced in the use of anticancer drugs. Dasatinib may cause undesirable or severe side effects at normal
therapeutic dosage levels. The patient may also require routine laboratory monitoring.
G/TBT/N/CAN/218
Page 2
- Deferasirox is used to treat chronic iron overload caused by blood transfusions for the
treatment of anemia. Therapy with deferasirox should be initiated and maintained by a
practitioner experienced in the treatment of chronic iron overload due to blood
transfusions. Individualized instructions and/or direct supervision by a practitioner is
required for treatment with deferasirox. The patient may also require routine laboratory
monitoring.
- Lumiracoxib is a non-steroidal anti-inflammatory drug (NSAID) that is used to treat
pain and swelling in adults, such as osteoarthritis of the knee. Treatment with
lumiracoxib requires individualized instructions or direct supervision by a practitioner,
particularly in patients with heart or liver disease. The patient may also require
treatment with other drugs and routine laboratory monitoring. Lumiracoxib may cause
undesirable or severe side effects at normal therapeutic dosage levels.
- Posaconazole is an antifungal agent that kills or stops the growth of some types of
fungi that can cause infections in humans. Posaconazole is indicated for adult patients
who have weakened immune systems due to other medicines or diseases. Individualized
instructions or direct supervision by a practitioner are required. Posaconazole may have
undesirable or severe side effects at normal therapeutic dosage levels.
- Telbivudine is indicated for the treatment of Hepatitis B in adults with chronic
hepatitis B infection and active liver inflammation. Treatment with telbivudine requires
practitioner supervision and routine lab monitoring particularly in patients with kidney
disease. Telbivudine may have undesirable or severe side effects at normal therapeutic
dosage levels.
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 practitioner
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 human 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. 1540, letter posted: 3 October 2007.
9.
10.
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.
Final date for comments: 17 December 2007
G/TBT/N/CAN/218
Page 3
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. 1540 can be downloaded at:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/noticeavis/project_projet_1540_e.html