JPN/751
WTO/TBT
JP Japon
  • 30 - Produits pharmaceutiques
2022-12-01
2022-11-01

Pharmaceutical products (HS code(s): 30)

Partial amendment to the Minimum Requirements for Biological Products (1 page, available in English). Partial amendment to The Public Notice on National Release Testing.

The Minimum Requirements for Biological Products will be amended as follows; The test for abnormal toxicity ("test for freedom from abnormal toxicity") will be deleted from monographs for "Influenza HA Vaccine", "Diphtheria Toxoid", "Adsorbed Diphtheria Toxoid", "Adsorbed Diphtheria-tetanus Combined Toxoid", "Tetanus Toxoid", "Adsorbed Tetanus Toxoid", "Adsorbed Purified Pertussis Vaccine", "Adsorbed Diphtheria-purified Pertussis-tetanus Combined Vaccine", "Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine", and "Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Salk Vaccine) Combined Vaccine".

The Public Notice on National Release Testing will be amended as follows; Partially amended to"Influenza HA Vaccine", "Diphtheria Toxoid", "Adsorbed Diphtheria Toxoid", "Adsorbed Diphtheria Toxoid for Adult Use", "Adsorbed Diphtheria-tetanus Combined Toxoid", "Tetanus Toxoid", "Adsorbed Tetanus Toxoid", "Adsorbed Purified Pertussis Vaccine", "Adsorbed Diphtheria-purified Pertussis-tetanus Combined Vaccine", "Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine", "Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Salk Vaccine) Combined Vaccine", with the amendment of The Minimum Requirements for Biological Products.