TBT BSN | Notification

Notification Detail :: G/TBT/N/JPN/784

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Partial amendment to the Minimum Requirements for Biological ProductsPartial amendment to The Public Notice on National Release Testing.

Objective

Other (TBT)

Product Covered

 Pharmaceutical products (HS: 30)

Document Notification

Link to ePing

HSCODE

30 - PHARMACEUTICAL PRODUCTS

ICSCODE

11.120 - Pharmaceutics

Keywords

Human health

Specific Regions

Description

The Minimum Requirements for Biological Products will be amended as follows: The standard for “Frozen Human Red Blood Cells” that is to be newly approved will be added. And regarding the standard for “Recombinant Respiratory Syncytial virus Vaccine”, the section of “Cell Bank” and “Identification test on cultured CHO cell” will be partially amended. In addition, regarding the standard for “Coronavirus (SARS-CoV-2) RNA Vaccine”, the section such as “Descriptive definition” , “Bulk material” and “Identity test” will be partially amended.The Public Notice on National Release Testing will be amended as follows: The quantity for “Coronavirus (SARS-CoV-2) RNA Vaccine” will be partially amended. And, the criterion, fee and quantity for “Freeze-dried Gas Gangrene Antitoxin, Equine”, “Freeze-dried Diphtheria Antitoxin, Equine”, “Freeze-dried Recombinant Herpes Zoster Vaccine (Prepared from Chinese Hamster Ovary Cells)”, “Freeze-dried Habu Antivenom, Equine”, “Freeze-dried Botulism Antitoxin, Equine” and “Freeze-dried Mamushi Antivenom, Equine” will be partially amended. In addition, “Adsorbed Diphtheria-purified Pertussis-tetanus Combined Vaccine (bulk material)” and “Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio Combined Vaccine (bulk material)” will be deleted.

Notified Document

1:File here

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

Back

Notification Detail :: G/TBT/N/JPN/784

Link to ePing

App Settings