WORLD TRADE G/TBT/Notif.97.129
15April 1997
ORGANIZATION
(97-1618)
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
Agency orauthority designated tohandle comments regarding thenotification canbe
indicated ifdifferent from above:
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): Medicinal products,
blood andblood products, transplants, medical devices andinvitrodiagnostic devices
5. Title, number ofpages andlanguage(s) ofthenotified document: Federal Medicines Act
6. Description ofcontent: Thelawregulates:
-Thecontrol ofthequality, safety andefficacy ofmedicines bymeans ofanalytical,
conformity andregistration procedures, thecontrol ofmanufacturing practices
(GMP), andpost-marketing surveillance;
-thecontrol oftheimport andexport ofmedicines;
-theofficial monitoring oftheclinical trials (GCP);
-establishment ofasystem ofcontrol ofmedicines inSwitzerland andthe
establishment ofaSwiss Institute forMedicines.
7. Objective andrationale: Inorder toprotect thehealth ofhumans andanimals, thelaw
ensures thatmarketed medicines areofahighquality, safety andefficacy andwillbe
usedcorrectly. Thisactprovides auniform regulation ofthemedicines inSwitzerland.
8. Relevant documents: Regulations governing theimplementation oftheAct,ifnotyetin
force, willbeissued atalaterdateintheform ofdecrees.
9. Proposed dateofadoption:
Proposed dateofentry intoforce:1July2000
10. Final dateforcomments: 9June1997
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: