RESTRICTED
WORLD TRADE G/TBT/Notif.95.232
2August 1995
ORGANIZATION
(95-2292)
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 Health 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 (Schedule No.774)(pages 2262-2265)
6. Description ofcontent: Thisregulatory proposal amends theFood andDrug Regulations
toensure thefollowing standards forallparenteral drugs:
(1) except forthose parenteral drugs which areinherently pyrogenic, allparenteral
drugs must befreefrom pyrogens (fever-producing substances) including drugs
where theindividual dose recommended bythemanufacturer islessthan
fivemillilitres;
(2) thatpackaging components donotaffect thepurity orpotency ofthecontents;
(3) protection ofthedrugproduct from degradation sources suchasgases, lightand
micro-organisms;
(4) thatcontainers, whether plastic orglass, permit theinspection ofthecontents
either visually orbyother means;
(5) thatthere beasufficient quantity ofthedruginthecontainer marketed toallow
thewithdrawal ofthelabelled amount.
7. Objective andrationale: Protection ofhuman health
8. Relevant documents: Canada Gazette, PartI,8July1995.
9. Proposed dateofadoption andentry intoforce: Notstated
10. Final dateforcomments: 7August 1995
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: