This presentation discusses the roles and responsibilities of parties involved in obtaining and maintaining Korean product licenses, including license holders, representatives, and agents. It defines key terms like license holder and outlines duties around customs clearance, reporting changes, and communication channels. The presentation notes that changing the license holder can be done cooperatively via contract or requires reregistering all products. It also discusses options for companies like using a distributor, registration specialist, or establishing their own Korean branch to become the license holder.

1. Presented by Nicolas Clary
(Kobridge Consulting Ltd.)

2. Agenda :
Definitions
Duties of parties involved
Changing representation
Becoming license holder
Distributing products
Impact on KGMP
Different options

4. Definitions
Korean License
Holder
European
Representative
US Agent

5. Definitions
License holder = established
place of business in Korea
responsible to place the product
on the market

6. Definitions
License holder can be involved
in the registration of the
product (not an obligation)

7. License
Holder =
owner of
product
licenses

8. Legal
responsibi
lities -
penalties

10. Duties of the parties involved
What are the License holder
duties ?

11. Customs
Clearance

12. Duties of the parties involved
Importer = License holder
BUT
Clearance and inspection can be
subcontracted to distributor

13. Duties of the parties involved
Report any
design/manufacturing changes
to the MFDS

14. Duties of the parties involved
Communication
Channel for
Recalls, events…
Manufacturer
License
Holder
MFDS

16. Changing license holder
Cooperative Mode Non-cooperative mode
Contract
between
former and
new license
holder
All products
have to be
registered
again

17. Changing license holder
Cycle time for the transfer:
A couple of weeks

19. Becoming a license holder
2 things are needed

20. Place of
business
in Korea

21. QA
manager

23. Impact on KGMP
KGMP also has to be
transferred.
Can be done at the same time
OR after product license
transfer

25. Different options
Distributor
• Ease in
handling
• Experience
• Cost
RA specialist
• Experience
• Flexibility
• Post-market
Branch
• Flexibility
• Post-market
• Ownership

27. Breaking
free from
the
distributor

28. How can we help ?
We provide all submitted
documents to our clients
In our contract we make sure
any change is possible

29. The future ?
We want to provide our clients
a “one-stop” service for them to
establish a branch in Korea and
then become license holder

30. Nicolas Clary
Kobridge Consulting
+82 2 3450 1690
Nicolas.clary@kobridgeconsulting.com
www.kobridgeconsulting.com