WORLD TRADE G/TBT/Notif.98.179
15April 1998
ORGANIZATION
(98-1495)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: MEXICO
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: Ministry ofHealth
Agency orauthority designated tohandle comments regarding thenotification shall be
indicated ifdifferent from above: Contact point
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): Generic drugs
5. Title, number ofpages andlanguage(s) ofthenotified document: Mexican Official
Emergency Standard NOM-EM-003-SSA1-1998, Interchangeable Generic Drugs. Test
Criteria andRequirements toDemonstrate Interchangeability andRequirements tobe
MetbyAuthorized Third Parties (21pages, Spanish)
6. Description ofcontent: This Mexican Official Emergency Standard laysdown the
criteria andrequirements tobesatisfied fortheconduct oftests todemonstrate the
interchangeability ofdrugs, aswellastherequirements tobeobserved byestablishments
which carry outsuch tests. Compliance with thisMexican Official Standard is
mandatory inMexican territory forallestablishments which carry outtests to
demonstrate theinterchangeability ofdrugs.
7. Objective andrationale, including thenature ofurgent problems where applicable:
Safety
8. Relevant documents: Diario Oficial delaFederación (Official Journal) of
25March 1998
9. Proposed dateofadoption:
Proposed dateofentry intoforce:26March 1998
10. Final dateforcomments: Notapplicable
11. Texts available from: National enquiry point [X]oraddress, e-mail andtelefax number
ofother body: