RESTRICTED
WORLD TRADE G/TBT/Notif.95.137/Rev.1
22December 1995
ORGANIZATION
(95-4148)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: BELGIUM
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: Ministry ofPublic Health andtheEnvironment
Therapeutic Practice Service
Quartier Vésale V.605
1010 Brussels
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): Human blood andlabile
blood products, i.e.blood derivatives fortherapeutic usewhich areonlyviable fora
short period oftimeiftheyarenolonger stored properly.
5. Title andnumber ofpages ofthenotified document: Royal Order ontheTaking,
Preparing, Storing andDelivering ofHuman Blood andBlood Products
6. Description ofcontent: Thisdraftimplements theLawof5July1994 onhuman blood
andblood products. Itfixesthecriteria forapproving centres andestablishments which
take, prepare, store anddeliver human blood andblood products. Thecriteria for
approval areparticularly aimed atguaranteeing self-sufficiency inassuring availability
andquality. Forthispurpose, thedraft specifies theobligations ofthecentres and
establishments, theconditions under which theymust operate, themethods ofdonor
recruitment, theconditions forstoring andpreparing blood andblood products, aswell
asquality criteria. Italsospecifies theconditions foruseofplastic containers.
7. Objective andrationale: Thepurpose ofthedraft Order istodefine theterms of
implementation oftheLawof5July1994 onhuman blood andblood products. The
aimofthemeasures taken istoensure self-sufficiency ofsupply, toguarantee thepurity
oftheproduct.
./.G/TBT/Notif/95.137/Rev.1
Page2
8. Relevant documents: Lawof5July1994 onhuman blood andblood products.
Royal Order of10November 1971 onthetaking, preparing, storing and
delivering ofhuman blood andblood products fortherapeutic use,andamending
legislation.
9. Proposed dateofadoption andentry intoforce: 60days
10. Final dateforcomments:
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: CIBELNOR