SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Jeonghoon Hong and Soo Yeon Park, Lee & Ko
7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies The PAA and MDA are the primary laws govern- ing the import and export of pharmaceuticals and medical devices, while the Customs Act and Integrated Public Announcement promulgated by the Ministry of Trade, Industry and Energy (MOTIE) pursuant to the Foreign Trade Act, apply the requirements of the PAA and MDA to the actual customs process. In principle, pharmaceuticals and medical devic- es manufactured abroad are subject to the same regulations as those manufactured domestically. The importers of such products are responsible for obtaining the necessary licences from the MFDS, such as import business licences and marketing authorisation for particular products, and complying with all obligations under the PAA or MDA, such as quality testing. In addi- tion to the above, importers also need to register overseas manufacturing facilities and undergo inspections of those facilities. A manufacturing business licence and manufac- turing authorisations for particular products are required for the manufacture of pharmaceuticals or medical devices, whether for domestic use or export. However, manufacturing authorisations for pharmaceuticals or medical devices that are only exported, and not sold or distributed domestically, are exempted from certain require- ments and do not require renewal. The MFDS regulates licences and authorisations for both pharmaceuticals and medical devices,
can be expected even when used without a prescription by a physician; • a drug that may be used to treat a disease without a physician’s or dentist’s professional knowledge; and/or • a drug which has a relatively small side effect on human bodies in light of their dosage form and pharmacological action. Emergency drugs among the OTC drugs are used mainly for minor symptoms at the sole dis- cretion of patients, and are publicly notified and prescribed by the Minister of Health and Welfare. Such emergency drugs can be purchased at places other than pharmacies. Conversely, pre- scription drugs mean drugs which are not OTC drugs and require a physician’s prescription. Meanwhile, orphan drugs mean either drugs used for the purposes of diagnosis or treat- ment of rare diseases under the Rare Disease Management Act or drugs with rare subject of application, whose alternative drug does not exist or whose safety or efficacy has been sig- nificantly improved compared to its alternative drug, which are designated by the Minister of Food and Drug Safety. Other than the above, drugs essential for health and medical treatment, whose stable supply is difficult based only on market function, are designated and managed as national essential drugs.
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