WORLD TRADE G/TBT/Notif.98.128
9March 1998
ORGANIZATION
(98-0917)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: JAPAN
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: Ministry ofHealth andWelfare
Agency orauthority designated tohandle comments regarding thenotification shallbe
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):
Drugs (HS:30)
5. Title, number ofpages andlanguage(s) ofthenotified document: Revision ofthe
Minimum Requirements forAntibiotic Products ofJapan (2pages, available inEnglish)
6. Description ofcontent: Under theprovision ofArticle 42paragraph 1ofPharmaceutical
Affairs Law, theMinister ofHealth andWelfare willrevise theMinimum Requirements
forAntibiotic Products ofJapan.
7. Objective andrationale, including thenature ofurgent problems where applicable: To
revise thecompendial testmethods andspecifications (manufacturing, description,
quality andstorage) forantibiotic products which have been already approved bythe
Minister inaccordance withthetechnical development
8. Relevant documents: Thebasic lawisthePharmaceutical Affairs Law. These revisions
willbemade public in"KAMPO" (Official Government Gazette) when adopted
9. Proposed dateofadoption:
Proposed dateofentry intoforce:June1998
10. Final dateforcomments: 31May1998
11. Texts available from: National enquiry point [X]oraddress, e-mail andtelefax number
ofother body: