KR Südkorea
  • 30 - Pharmazeutische Erzeugnisse

Advanced Biological Products (HS: 3004-90-9900); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic purposes, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. medicaments containing antibiotics, medicaments containing hormones or steroids used as hormones, but not containing antibiotics, medicaments containing alkaloids or derivates thereof but not containing hormones or antibiotics and medicaments containing provitamins, vitamins or derivates thereof used as vitamins) (HS 300490)

The draft regulation on the "Review and Approval of Advanced Biological Products" (94 page(s), in Korean)

As the Act on the Safety and Support of Advanced Biological Products was established, the Regulations on the Review and Approval of Advanced Biological Products was enacted to stipulate document requirements and evaluation criteria for the approval of advanced biological products.