./.WORLD TRADE
ORGANIZATIONG/TBT/N/CAN/34
7 May 2002
(02-2562)
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.:  +1 613 238 3222,
ext. 491, Fax.:  +1 613 569 7808, E-mail:  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):   Human plasma
(ICS:  11.120)
5. Title, number of pages and language(s) of the notified document:   Proposed Amendment
to the Food and Drug Regulations (Schedule No. 1100) (pages 1150-1152;  English andFrench)
6. Description of content:   This notice is to advise the public of our intention to proceed with
the amendment of the regulatory provisions respecting Human Plasma Collected by
Plasmapheresis located in Part C, Division 4 of the Food and Drug Regulations  (FDR or the
Regulations). This proposed initiative will, among other things, bring the regulatory
requirements up to date to reflect current practices and advances in technology.
Human plasma is collected by plasmapheresis either for transfusion purposes or as a bulk
process intermediate used in the manufacturing of blood products (e.g., products used totreat burn victims or patients with life threatening infections).
This regulatory initiative only applies to human plasma collected by plasmapheresis for
further manufacturing. Requirements for plasma intended for transfusion will be
incorporated into a separate regulatory initiative for blood and blood components which is
currently under development.
The intent of the plasmapheresis regulatory requirements are two-fold:
(1) To contribute towards maintaining the health of the plasma donor;  and
(2) to contribute to the goal of ensuring the quality and safety of human plasma collected
by plasmapheresis for further manufacturing.G/TBT/N/CAN/34
Page 2
7. Objective and rationale, including the na ture of urgent problems where applicable:
Protection of human health
8. Relevant documents:   Canada Gazette, Part I, 27 April 2002
9. Proposed date of adoption:
Proposed date of entry into force: }Not stated
10. Final date for comments:   26 June 2002
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 this document can be downloaded at: http://canada.gc.ca/gazette/part1/pdf/g1-
13617.pdf