PAL definition: Biological Product
PAL
Article 2 (Definitions)
Paragraph 9. The term "biological product"used in this law refers to a drug, quasi-drug, cosmetic or medical device designated by the Minister of MHLW after seeking the opinion of Pharmaceutical Affairs and Food Sanitation Council (PAFSC), as manufactured (including repackaging; the same hereinafter) with materials derived from humans or other organisms (excluding plant) as the source materials, and requiring special caution from the viewpoint of the public health and hygiene.
