JAPAN: ANIMAL ANTIBIOTICS The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif. 95.226. 1. Member to Agreement notifying: Japan. If applicable, name of local government involved (Articles 3.2 and 7.2): 2. Agency responsible: Ministry of Agriculture, Forestry and Fisheries. 3. Notified under Article 2.9.2. 4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Animal antibiotics (HS: 3004.10-010, 3004.20-000). 5. Title and number of pages of the notified document: Amendment to the Minimum Requirements for Antibiotic Products for Animal Use (available in Japanese, 1 page). 6. Description of content: Add standards for the following products to the Minimum Requirements for Antibiotic Products for Animal Use: (1) Ampicillin injection in oily suspension (animal), (2) Bicozamycin for injection (animal), (3) Chloramphenicol injection in aqueous suspension (animal), (4) Dihydrostreptomycin sulfate injection (animal), (5) Dihydrostreptomycin sulfate for injection (animal), (6) Erythromycin injection (animal), (7) Mecillinam for injection (animal), (8) Oxytetracycline hydrochloride injection (animal), (9) Benzylpenicillin procaine injection in aqueous suspension (animal), (10) Spectinomycin hydrochloride injection (animal), (11) Tiamulin oily injection (animal), (12) Terudecamycin for injection (animal), (13) Tylosin injection (animal), (14) Tylosin tartrate for injection (animal), (15) Benzylpenicillin procaine-benzylpenicillin benetamine injection in aqueous suspension (animal), (16) Dihydrostreptomycin sulfate-benzylpenicillin procaine injection (animal), (17) Oleandomycin phosphate-tetracycline hydrochloride for injection (animal), (18) Ampicillin for intrauterine infusion (animal), (19) Cefaronium oily intramammary suspension (animal), (20) Cefazorine oily intramammary suspension (animal), (21) Cloxacillin sodium oily intramammary suspension (animal), (22) Cloxacillin benzathine oily intramammary suspension (animal), (23) Cefuroxime sodium oily intramammary suspension (animal), (24) Dicloxacillin sodium oily intramammary suspension (animal), (25) Dicloxacillin sodium for intramammary aerosol infusion (animal), (26) Erythromycin oily intramammary suspension (animal), (27) Kanamycin sulfate intratracheal aerosol (animal), (28) Sodium nafcillin monohydrate oily intramammary suspension (animal), (29) Oxytetracycline hydrochloride intramammary solution (animal), (30) Oleandomycin phosphate-oxytetracycline hydrochloride oily intramammary suspension (animal), (31) Dihydrostreptomycin sulfate-benzylpenicillin procaine oily intramammary suspension (animal), (32) Dihydrostreptomycin sulfate-benzylpenicillin procaine oily intramammary aerosol (animal), (33) Dihydrostreptomycin sulfate-benzylpenicillin procaine for intratracheal infusion (animal), (34) Dihydrostreptomycin sulfate-benzylpenicillin procaine oily intrauterin suspension (animal), (35) Fradiomycin sulfate-benzylpenicillin procaine oily intramammary suspension (animal), (36) Kanamycin sulfate-benzylpenicillin procaine oily intramammary suspension (animal), (37) Kanamycin sulfate-benzylpenicillin procaine oily intramammary aerosol (animal), (38) Sodium nobobiosine-benzylpenicillin procaine oily intramammary suspension (animal), (39) Ampicillin suppository (animal), (40) Chlortetracycline hydrochloride intrauterine and intravaginal tablet (animal), (41) Oxytetracyline hydrochloride intrauterine and intravaginal tablet (animal), (42) Nanafrocin oily solution (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 for semen dilution (animal). 7. Objective and rationale: To ensure the quality of antibiotic products for animal use. 8. Relevant documents: The basic law is the Pharmaceutical Affairs Law. The said standards will appear in ``KAMPO'' (Official Government Gazette) when adopted. 9. Proposed date of adoption and entry into force: October 1995. 10. Final date for comments: 21 September 1995. (227)

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