SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Jeonghoon Hong and Soo Yeon Park, Lee & Ko
while the Korean Customs Service enforces the relevant regulations at the point of entry for imports. 7.2 Importer of Record of Pharmaceuticals and Medical Devices Only those with an import business licence from the MFDS for pharmaceuticals or medical devic- es can act as their importer of record. In order to receive an import business licence for either pharmaceuticals or medical devices, the entity applying for the licence must fulfil certain requirements, such as having the required stor- age facilities, quality testing facilities and equip- ment, and personnel such as import managers and safety managers. Additionally, local pres- ence is required in order to hold an import busi- ness licence for pharmaceuticals and medical devices. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices In principle, only entities with an import busi- ness licence and marketing authorisation for the particular imported product can import pharma- ceuticals or medical devices into Korea. Exceptions of varying degrees to this rule include imports for the treatment of rare diseases, emer- gency use, clinical trials, research and testing, and personal use. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports The Customs Act requires those who import products required by law to have approval, licence, labelling or fulfil other requirements for their importation to show proof of the fulfilment of such conditions to the head of the competent customs office, which for pharmaceuticals and medical devices are the requirements imposed
by either the PAA (for pharmaceuticals) or the MDA (for medical devices), see 7.1 Governing Law for the Import and Export of Pharma- ceuticals and Medical Devices and Relevant Enforcement Bodies to 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices . Whether the imported product is subject to the regulations and requirements of either the PAA or MDA would be determined by whether the product satisfies the criteria for pharmaceuticals or medical devices as defined in the respective acts. 7.5 Trade Blocs and Free Trade Agreements As of February 2025, Korea has entered into 22 economic partnership agreements and free trade agreements with other countries, all 22 of which (the RCEP and FTAs with Chile, Singa- pore, EFTA, ASEAN, India, the European Union, Peru, the United States, Türkiye, Australia, Canada, China, New Zealand, Vietnam, Colom- bia, MERCOSUR, the United Kingdom, RCEP, Israel, Cambodia, Indonesia and Philippines) are in force. 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices The government’s price control for pharmaceu- ticals is based on the relevant laws such as the National Health Insurance Act (NHIA), the Rules on the Standards of National Health Insurance Medical Benefits, and the Standards for Decision or Adjustment on Drugs. Also, the government’s price control for medical devices is in accord- ance with NHIA, the Rules on the Standards
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