RESTRICTED
WORLD TRADE G/TBT/Notif.95.1
16January 1995
ORGANISATION Special Distribution
(95-0031)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: CANADA
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: Department ofNational Wealth andWelfare
3. Notified under Article 2.9.2 [X],2.10.1 [],5.6.2 [],5.7.1 [],other:
4. Products covered (HSorCCCN where applicable, otherwise national tariff heading.
ICSnumbers maybeprovided inaddition, where applicable): Drugs
5. Titleandnumber ofpages ofthenotified document: Proposed Amendment totheFood
andDrug Regulations (pages 4787-4799)
6. Description ofcontent: This initiative establishes aregulatory framework for
abbreviated newdrugsubmissions. Theamendment provides adefinition foraCanadian
reference product thereby providing manufacturers andconsumers withaclearly defined
standard. Thisregulatory initiative alsodefines specific requirements foranabbreviated
newdrugsubmission.
7. Objective andrationale: Protection andhuman safety
8. Relevant documents: Canada Gazette, PartI,24December 1994
9. Proposed dateofadoption andentry intoforce: Notstated
10. Final dateforcomments: 22February 1995
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: