RESTRICTED
WORLD TRADE G/TBT/Notif.96.13
31January 1996
ORGANIZATION
(96-0395)
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 may beprovided inaddition, where applicable): In-vitro diagnostic
products
5. Title andnumber ofpages ofthenotified document: Ordinance Concerning In-Vitro
Diagnostic Products
6. Description ofcontent: TheOrdinance of24February 1993 Concerning In-Vitro
Diagnostics covers onlythose products forthedetection ofinfectious diseases which use
astheir testprinciple animmunological reaction (thedetection ofanantigen or
antibody). Itstipulates forthese products either apre-marketing notification, orinthe
caseoftests forthedetection ofHIV, Hepatitis BorHepatitis C,apre-marketing
approval.
Newly included intheOrdinance areallin-vitro diagnostics, e.g.testsforthe
detection ofinfectious agents which arebased onmethods other thanimmunological
reactions (e.g. thePolymerise Chain Reaction), pregnancy tests, andtests forthe
determination ofblood groups.
Apre-marketing approval willberequired foralltestsdesigned forthedetection
ofHIV, Hepatitis BandHepatitis C;forallother tests, apre-marketing notification
willberequired.
7. Objective andrationale: TheFederal Resolution concerning thecontrol ofblood, blood
products andtransplants withanalteration oftheEpidemic Lawof18December 1970
(theparliamentary consultation isexpected tobeconcluded inMarch 1996).
./.G/TBT/Notif.96.13
Page2
7. Objective andrationale (cont'd): The Resolution oftheFederal Council of
9November 1994 concerning thefuture Medicines Control Act.
8. Relevant documents: Revised Edict: theOrdinance of24February 1993 Concerning
In-Vitro Diagnostics
9. Proposed dateofadoption andentry intoforce: 1July1996
10. Final dateforcomments: 25March 1996
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: