Advanced bio-medicine and human cells

Basic information

1

Outline of the system

By embracing the principle of free trade, Korea has continued to reduce its trade-related regulations. In this context, restrictions on trade, if any, are limited to the very minimum necessary.

As a general rule, no licensing (since 1 July 1993), registration (since 1 March 1997) or notification (since 1 January 2000) is required for importers and exporters.

The Foreign Trade Act is the basic law that governs international trade between Korea and other countries. Specific items for which exports and/or imports are restricted are listed under the Export-Import Notice published by the Ministry of Trade, Industry & Energy (MOTIE). However, at present, no item is subject to import restrictions under the Export-Import Notice except aircraft parts.

In addition to the Foreign Trade Act, 60 separate laws also stipulate approval or authorization requirements for certain items, and such items can be imported by obtaining certifications and approval. These requirements are in place mostly for the protection of morals, human health, hygiene and sanitation, animal and plant life, aquatic animal and aquatic plant health, environmental conservation or essential security interests in compliance with domestic legislation obligations or international commitments.

To enhance transparency and for the convenience of trading companies, MOTIE has updated the Consolidated Public Notice containing all export and import certification requirements covered by the 60 separate laws.

2

Product coverage

As of September 2011, there are no quantitative import restrictions. In addition, rice has not been subject to quantitative import restrictions since 2015 due to "tariffication". Import-related requirements provided by the 60 separate laws pertain to petroleum, agricultural fertilizers, crop seeds, animals and animal products, nuclear materials, narcotics, foods and food additives, firearms and explosives, etc.

Advanced bio-medicine and human cells. See Products

Nature of licensing

Automatic

3

If Automatic, administrative purpose

Non-Automatic

4

If Non-Automatic, description of the notified Non-Automatic Licensing regime

Non-automatic licensing to protect human, animal or plant life and health

5

Products under restriction as to the quantity or value of imports

No import-related regulations are intended to restrict the quantity or value of imports. Rather, they are maintained in order to protect national security, human, animal or plant life or health, and the environment, etc. in accordance with the provisions of Articles XX and XXI of GATT 1994, other WTO Agreements and other international rules or agreements.

6

Questions for products under restriction as to the quantity or value of imports

Not applicable

7

The system applies to products originating from which country?

The system applies to goods originating in and coming from all countries.

8

Expected duration of licensing procedure

There is no related regulation

Eligibility of applicants

12

Is there a system of registration of persons or firms permitted to engage in importation?

No licensing (since 1 July 1993), registration (since 30 December 1996) or notification (since 1 January 2000) is required to become and importer or exporter.

13

What persons or firms are eligible to apply for a licence?

For statistical purposes only, the Korea International Trade Association (KITA), a private organization, assigns upon request a trade business number to anyone who wishes to carry out trade business.

14

Is there a registration fee?

15

Is there a published list of authorized importers?

Contact point for information on eligibility

16

Ministry/Authority

Ministry of Food and Drug Safety, Regional Office of Food and Drug Safety; Korea Pharmaceutical Traders Association

17

Address

187, Osongsaengmyeong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea, 28159/33, Magokdong-ro, Gangdeo-gu, Seoul, Republic of Korea, 07806

18

Telephone

+82-43-719-3304/+82-2-2162-8000

19

Fax

20

E-mail address

22

Contact officer

Submission of an application

23

Administrative body(ies) for submission of an application

Ministry of Food and Drug Safety, Regional Office of Food and Drug Safety; Korea Pharmaceutical Traders Association

Documentation requirements

24

What information is required in applications?

An offer sheet or a copy of the contract and other necessary documents must be submitted together with the application. Please see attached Sample Form

N3KOR14 - sample forms.pdf
25

What documents is the importer required to supply with the application?

An offer sheet or a copy of the contract and other necessary documents must be submitted together with the application. Please see attached Sample Form

Window of submission of an application

26

How far in advance of importation must application for a licence be made?

Not applicable.

27

Are there any limitations as to the period of the year during which application for licence can be made? If so, explain

Not applicable.

Issuing the license

28

Can a licence be granted immediately on request?

Not applicable.

29

Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence

Not applicable.

30

Which administrative body is responsible for approving application of licences?

Ministry of Food and Drug Safety, Regional Office of Food and Drug Safety; Korea Pharmaceutical Traders Association

31

Must the applications be passed on to other organs for visa, note or approval?

Not applicable.

32

Are there any other conditions attached to the issue of a licence?

There are no other conditions associated with the issuing of a licence.

Fees and other administrative charges

33

Is there any licensing fee or administrative charge?

There is no licensing fee or administrative charge.

34

What is the amount of the fee or charge?

35

Is there any deposit or advance payment required associated with the issue of licences?

There is no deposit or advance payment requirement associated with the issue of licences.

36

Amount or rate?

37

Is it refundable?

38

What is the period of retention?

39

What is the purpose of this requirement?

Refusal of an application

40

Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?

An application for approval cannot be rejected if it satisfies the established criteria.

41

Are the reasons for any refusal given to applicants?

42

Have applicants a right of appeal in the event of refusal to issue a licence?

43

If so, to what bodies and under what procedures?

Importation

44

Are there any limitations as to the period of year during which importation may be made?

Not applicable.

45

What documents are required upon actual importation?

In the case of import-restricted items, the import declaration, import approval, commercial invoice, Bill of Lading and other necessary documents must be submitted.

46

Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?

There are no other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation.

Conditions of licensing

47

What is the period of validity of a licence? Can the validity be extended? How?

In principle, the period of validity for import approval is one year. However, the period can be extended or shortened, depending on specific circumstances, when the approval is issued by the relevant administrative agency.

48

Is there any penalty for the non-utilization of a licence or a portion of a licence?

There is no penalty for the non-utilisation of a licence or a portion of a licence.

49

Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?

Licences are not transferable between importers.

Foreign Exchange

50

Is foreign exchange automatically provided by the banking authorities for goods to be imported?

Foreign exchange is provided automatically for goods to be imported under the standard settlement method.

51

Is a licence required as a condition to obtaining foreign exchange?

52

Is foreign exchange always available to cover licences issued?

53

What formalities must be fulfilled for obtaining the foreign exchange?