JPN/743
WTO/TBT
JP Japan
  • 30 - Pharmazeutische Erzeugnisse
2022-08-10
2022-07-14

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;To add the standard, criterion, fee and quantity for a vaccine product to be newly approved; "Meningococcal tetravalent polysaccharide tetanus toxoid conjugate vaccine", "Pneumococcal 15-valent conjugate vaccine". Partially amended to "Meningococcal tetravalent polysaccharide diphtheria toxoid conjugate vaccine", "Pneumococcal Vaccine Polyvalent", "Pneumococcal 13-valent conjugate vaccine", "Smallpox Vaccine Prepared in Cell Culture", "Freeze-dried Smallpox Vaccine Prepared in Cell Culture". To delete "Pneumococcal 10-valent conjugate vaccine", "Smallpox Vaccine", "Freeze-dried Smallpox Vaccine". 

The Public Notice on National Release Testing will be amended as follows; To add the criterion, fee and quantity for a vaccine product to be newly approved; "Meningococcal tetravalent polysaccharide tetanus toxoid conjugate vaccine", "Pneumococcal 15-valent conjugate vaccine". Partially amended to "Meningococcal tetravalent polysaccharide diphtheria toxoid conjugate vaccine", "Pneumococcal Vaccine Polyvalent", "Pneumococcal 13-valent conjugate vaccine", "Smallpox Vaccine Prepared in Cell Culture", "Freeze-dried Smallpox Vaccine Prepared in Cell Culture". To delete "Pneumococcal 10-valent conjugate vaccine", "Smallpox Vaccine", "Freeze-dried Smallpox Vaccine".