SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Eunkyoung Lyu and Soo Yeon Park, Lee & Ko
6.2 Different Classifications Applicable to Pharmaceuticals Pharmaceuticals are classified into OTC drugs and prescription drugs under the PAA. OTC drugs refer to any of the following drugs, which meet the standards determined and publicly notified by the Minister of Food and Drug Safety, following consultations with the Minister of Health and Welfare: • a drug, the misuse or abuse of which is of little concern, and whose safety and efficacy 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 discretion 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 phar- macies. Conversely, prescription 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 treatment of rare dis- eases under the Rare Disease Management Act or drugs with a rare subject of application, whose alter- native drug does not exist or whose safety or efficacy has been significantly improved compared to its alter- native 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.
essary documents with the competent local district of MFDS. The relevant MFDS office reviews whether the applicant for manufacturing approval (or, in the case of a company, its representative) meets the require- ments, whether all necessary documents are satisfied, and whether the applicant has the necessary facilities and labour force. If the requirements are satisfied, the MFDS grants authorisation. Once granted, the author- isation remains valid without any other special renewal procedure unless grounds for revocation occur under the PAA or the MDA. Of note, separate from MFDS’s authority under PAA/ MDA with regard to requirements for facilities and labour force, other licences/authorisations will be required for plant construction (such as those related to environment and safety). 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices Wholesale of pharmaceuticals is subject to authori- sation from the head of Si/Gun/Gu (ie, the local gov- ernment) in Korea. To obtain such authorisation, the applicant must meet prescribed qualifications and have a place of business, warehouse and other facili- ties as prescribed by Presidential Decree of the PAA. In principle, an authorised wholesaler is required to employ a pharmacist to manage the relevant tasks. The authorised wholesaler may sell or acquire phar- maceuticals for sales, provided that such pharmaceu- ticals comply with the standards for quality manage- ment of pharmaceuticals in distribution. There is no validity period for the authorisation of wholesale of pharmaceuticals. Meanwhile, the wholesale of medical devices is sub- ject to a notification of distribution with the competent Special Self-Governing Mayor, Special Self-Governing Province Governor, or the head of a Si/Gun/Gu. Once such notification of distribution is accepted, the per- son can distribute medical devices. There is no period of validity for wholesale notification.
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