World Trade Organization

Import Licensing Procedures

Advanced Regenerative Medicine and Advanced Biomedicine Safety and Support Act

Notifying member
Korea, Republic of
Title
Advanced Regenerative Medicine and Advanced Biomedicine Safety and Support Act
First published
27/08/2019
First EIF
28/08/2020
Latest published
In force to
Latest notification
G/LIC/N/3/KOR/16
Product categories
List of products subject to licensing

300190Dried glands and other organs for organo-therapeutic uses, whether or not powdered; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, n.e.s.

3002Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products

3003Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006)

3004Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those for transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006)

Attachment
Nature of licensing

Non-automatic

Administrative purpose/measure being implemented
  • Protect human, animal or plant life and health; protect environment
Administrative body(ies) for submission of applications
Ministry of Food and Drug Safety
187, Osongsaengmyeong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea, 28159
https://www.mfds.go.kr/eng/index.do
82-43-719-3304
Contact point for information on eligibility
Korea Pharmaceutical Traders Association
33, Magokdong-ro, Gangdeo-gu, Seoul, Republic of Korea, 07806
http://www.kpta.or.kr/eng/main/main.asp
82-2-2162-8000
Expected duration of licensing procedure
There is no related regulation
Found by secretariat
No
Links
Related document symbols
  • G/LIC/N/2/KOR/41
Source
Notes

  • G/LIC/N/2/KOR/41


    Only in Korean

    The purpose of this Act is to contribute to the improvement of public health and quality of life by preparing a system for securing safety of advanced regenerative medicine and measures for innovation and practical use of technology, and by prescribing matters necessary for securing the quality, safety, effectiveness, and support for commercialization of advanced bio-medicine.

    Those who import advanced bio-medicine and human cells must obtain permission from the Ministry of Food and Drug Safety (Regional Food and Drug Administration). And the importer can import them after completing the standard customs clearance report to the Korea Pharmaceutical Traders Association at each import.


    3001.90.1010, 3001.90.9020, 3002.11.0000, 3002.12.1000, 3002.12.9021, 3002.12.9022, 3002.12.9040, 3002.12.9090, 3002.13.9000, 3002.14.9000, 3002.15.0000, 3002.19.9000, 3002.30.9000, 3002.90.1000, 3002.90.2000, 3002.90.3010, 3002.90.3020, 3002.90.3090, 3002.90.4000, 3002.90.5000, 3002.90.9000, 3003, 3004


    Items related to advanced bio-medicine and human cells


    Imports may be carried out under the following condition: Those who import advanced bio-medicine and human cells must obtain permission from the Ministry of Food and Drug Safety (Regional Food and Drug Administration). And the importer can import them after completing the standard customs clearance report to the Korea Pharmaceutical Traders Association at each import.