RESTRICTED
WORLD TRADE G/TBT/Notif.95.226
25July1995
ORGANIZATION(95-2157)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: JAPAN
Ifapplicable, name oflocal government involved (Articles 3.2and7.2):
2. Agency responsible: Ministry ofAgriculture, Forestry andFisheries
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):
Animal antibiotics (HS :3004.10-010, 3004.20-000)
5. Title andnumber ofpages ofthenotified document: Amendment totheMinimum Requirements
forAntibiotic Products forAnimal Use(available inJapanese, 1page)
6. Description ofcontent: Addstandards forthefollowing products totheMinimum Requirements
forAntibiotic Products forAnimal Use:
(1) Ampicillin injection inoilysuspension (animal)
(2) Bicozamycin forinjection (animal)
(3) Chloramphenicol injection inaqueous suspension (animal)
(4) Dihydrostreptomycin sulfate injection (animal)
(5) Dihydrostreptomycin sulfate forinjection (animal)
(6) Erythromycin injection (animal)
(7) Mecillinam forinjection (animal)
(8) Oxytetracycline hydrochloride injection (animal)
(9) Benzylpenicillin procaine injection inaqueous suspension (animal)
(10) Spectinomycin hydrochloride injection (animal)
(11) Tiamulin oilyinjection (animal)
(12) Terudecamycin forinjection (animal)
(13) Tylosin injection (animal)
(14) Tylosin tartrate forinjection (animal)
(15) Benzylpenicillin procaine-benzylpenicillin benetamine injection inaqueous suspension
(animal)
(16) Dihydrostreptomycin sulfate-benzylpenicillin procaine injection (animal)
(17) Oleandomycin phosphate-tetracycline hydrochloride forinjection (animal)
./.G/TBT/Notif.95.226
Page2
6. Description ofcontent: (cont'd)
(18) Ampicillin forintrauterine infusion (animal)
(19) Cefaronium oilyintramammary suspension (animal)
(20) Cefazorine oilyintramammary suspension (animal)
(21) Cloxacillin sodium oilyintramammary suspension (animal)
(22) Cloxacillin benzathine oilyintramammary suspension (animal)
(23) Cefuroxime sodium oilyintramammary suspension (animal)
(24) Dicloxacillin sodium oilyintramammary suspension (animal)
(25) Dicloxacillin sodium forintramammary aerosol infusion (animal)
(26) Erythromycin oilyintramammary suspension (animal)
(27) Kanamycin sulfate intratracheal aerosol (animal)
(28) Sodium nafcillin monohydrate oilyintramammary suspension (animal)
(29) Oxytetracycline hydrochloride intramammary solution (animal)
(30) Oleandomycin phosphate-oxytetracycline hydrochloride oilyintramammary suspension
(animal)
(31) Dihydrostreptomycin sulfate-benzylpenicillin procaine oilyintramammary suspension
(animal)
(32) Dihydrostreptomycin sulfate-benzylpenicillin procaine oily intramammary aerosol
(animal)
(33) Dihydrostreptomycin sulfate-benzylpenicillin procaine forintratracheal infusion (animal)
(34) Dihydrostreptomycin sulfate-benzylpenicillin procaine oilyintrauterin suspension (animal)
(35) Fradiomycin sulfate-benzylpenicillin procaine oilyintramammary suspension (animal)
(36) Kanamycin sulfate-benzylpenicillin procaine oilyintramammary suspension (animal)
(37) Kanamycin sulfate-benzylpenicillin procaine oilyintramammary aerosol (animal)
(38) Sodium nobobiosine-benzylpenicillin procaine oilyintramammary suspension (animal)
(39) Ampicillin suppository (animal)
(40) Chlortetracycline hydrochloride intrauterine andintravaginal tablet (animal)
(41) Oxytetracyline hydrochloride intrauterine andintravaginal tablet (animal)
(42) Nanafrocin oilysolution (animal)
(43) Kanamycin sulfate intranasal solution (animal)
(44) Thiostrepton-griseofulvin-fradiomycin sulfate ointment (animal)
(45) Gliseofulvin external solution (animal)
(46) Chloramphenicol aerosol (animal)
(47) Fradiomycin sulfate external solution (animal)
(48) Dihydrostreptomycin sulfate-potassium benzylpenicillin tablet forsemen dilution (animal)
7. Objective andrationale: Toensure thequality ofantibiotic products foranimal use.
8. Relevant documents: Thebasic lawisthePharmaceutical Affairs Law. Thesaidstandards will
appear in"KAMPO" (Official Government Gazette) when adopted.
9. Proposed dateofadoption andentry intoforce: October 1995
10. Final dateforcomments: 21September 1995
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother body: