TBT BSN | Notification

Notification Detail :: G/TBT/N/JPN/791

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 Products_x000D_
Partial amendment to The Public Notice on National Release Testing.

Objective

Other (TBT)

Product Covered

Pharmaceutical products (HS: 30)

Document Notification

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HSCODE

30 - PHARMACEUTICAL PRODUCTS

ICSCODE

11.120 - Pharmaceutics

Keywords

Specific Regions

Description

The Minimum Requirements for Biological Products will be amended as follows:･ GENERAL RULESThe standard for “Tissue Culture Tick-borne Encephalitis Virus Vaccine”, “Pneumococcal 20-valent Conjugate Vaccine” and “Freeze-dried Human Protein C Concentrate” those are to be newly approved will be added. ・GENERAL TESTS Regarding the standard for “Antibody Assay against Measles Virus”, “Enzyme-linked Immunosorbent Assay” will be added.The Public Notice on National Release Testing will be amended as follows: The criterion, fee, and quantity for “Tissue Culture Tick-borne Encephalitis Virus Vaccine”, “Pneumococcal 20-valent Conjugate Vaccine” and “Freeze-dried Human Protein C Concentrate” that are to be newly approved will be added. And the criterion, fee, and quantity for “Freeze-dried Inactivated Tissue Culture Rabes Vaccine”, “Freeze-dried Human Fibrinogen”, “Freeze-dried Polyethylene Glycol-treated Normal Human Immunoglobulin” and “Freeze-dried Human Antithrombin Ⅲ Concentrate” will be partially amended. In addition, the criterion and fee for “Human Haptoglobin” will be partially amended.

Notified Document

1:File here

Link to Notification

EN:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/JPN/791

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