PHARMACEUTICAL PRODUCTS (HS code(s): 30)

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

The Minimum Requirements for Biological Products will be amended as follows:

･ GENERAL RULES

Regarding the standard for "Nasally Live Attenuated Influenza Vaccine", the section of "Attenuation Assay" will be deleted. And the standard for "Purified Typhoid Vi Polysaccharide Vaccine" that is to be newly approved will be added.

・STANDARDS

The section of "Standard Antimeasles Serum" will be partially amended.

The Public Notice on National Release Testing will be amended as follows:
The criterion, fee, and quantity for "Purified Typhoid Vi Polysaccharide Vaccine" that is to be newly approved will be added. And the criterion, fee, and quantity for "Human Serum Albumin" and "Freeze-dried Human Blood Coagulation Factor Ⅷ Concentrate" will be partially amended. In addition, the criterion and fee for "Human Plasma Protein Fraction" will be partially amended.