KOR/891
WTO/TBT
KR South Korea
  • 30 - Pharmaceutical products
2020-06-26
2020-04-28

Biological Products; - Other (HS 300190); - Other (HS 300490)

The enactment of enforcement rules for advanced biological products regarding safety and support (208 page(s), in Korean)

- As the Act regarding safety and support in advanced regenerative medicine and advanced biological products is established, "Enforcement rules for advanced biological products regarding safety and support" is enacted to prescribe the matters delegated by the Act and the matters required for its enforcement on the authorization and safety control of advanced biological products.

- Article 10, Article 22 to Article 24: to prescribe notification for importing businesses of advanced biological products, the approval process for imported products, obligations, etc.

- Article 27 to Article 31: to prescribe approval requirements, processes, and obligations, among others, for human cell management businesses, etc.