RESTRICTED
WORLD TRADE G/TBT/Notif.96.12
29January 1996
ORGANIZATION
(96-0331)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: SWITZERLAND
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: Federal Office ofPublic Health
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): Blood, blood components
andtransplants
5. Titleandnumber ofpages ofthenotified document: Ordinance Concerning theControl
ofBlood, Blood Components andTransplants
6. Description ofcontent: TheOrdinance isvalid foralltransactions involving blood,
blood products andtransplants, withtheexception ofthose areas inthemanufacturing,
storage, registration andbatch release ofstabile blood products which arealready
controlled bylaw, andproducts which arenotintended foruseinman (in-vitro
diagnostics).
TheOrdinance covers therequirements forgranting licences, anddefines the
precautions tobetaken when dealing withblood, blood products andtransplants, suchas
thecriteria governing acceptability ofblood donors, therequirements forconducting
testsforinfectious agents, labelling, documentation andstorage requirements, andthe
procedures anddocumentation required forhandling product complaints andrecalling
defective products.
Afundamental requirement isestablished toobtain andmanufacture blood and
labile blood products according totherules ofGood Manufacturing Practice, asbased
upon therules oftheEuropean Council, theWHO andtheDutch RedCross.
./.G/TBT/Notif.96.12
Page2
7. Objective andrationale: TheFederal Resolution concerning thecontrol ofblood, blood
products andtransplants (theparliamentary consultation isexpected tobeconcluded in
March 1996).
TheResolution oftheFederal Council of9November 1994 concerning the
future Medicines Control Act.
8. Relevant documents: Revised Edict: theOrdinance of9April 1986 concerning the
prevention oftransmission ofdangerous infective diseases bymeans ofblood andblood
products.
9. Proposed dateofadoption andentry intoforce: 1July1996
10. Final dateforcomments: 25March 1996
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: