SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Jeonghoon Hong and Soo Yeon Park, Lee & Ko
6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices Wholesale of pharmaceuticals is subject to authorisation from the head of Si/Gun/Gu (ie, the local government) in Korea. To obtain such authorisation, the applicant should meet qualifi- cations and have a business place, warehouse and other facilities as prescribed by Presidential Decree of the PAA. The authorised wholesaler is in principle required to employ a pharmacist to manage the relevant tasks. Such authorised wholesaler can sell or acquire pharmaceuticals for sales purposes which comply with the stand- ards for quality management of pharmaceuticals in distribution. There is no validity period for the authorisation of wholesale of pharmaceuticals. For the wholesale of medical devices, the whole- saler should file 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 notifica- tion of distribution is accepted, the person can distribute medical devices and there is no period of validity for wholesale notification. 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 pub- licly 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
MFDS may request additional data from domes- tic trials if it is deemed difficult to directly apply foreign clinical trial data. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices A manufacturing plant of pharmaceutical prod- ucts is subject to an authorisation for manufac- turing pharmaceuticals under the PAA, and a manufacturing plant of medical devices needs an authorisation for manufacturing medical devices under the MDA. The MFDS grants such authorisation. When a person, who intends to manufacture pharmaceuticals or medical devic- es, prepares and files the application for manu- facturing authorisation and necessary docu- ments with the local district of MFDS to which the manufacturer belongs, such local district MFDS reviews whether the applicant for manu- facturing approval (in the case of a company, the representative) is qualified, whether all nec- essary documents are satisfied, and assesses whether the applicant has necessary facilities and labour force, and if appropriate, it grants authorisation. Once authorisation is granted, it will be 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 facili- ties and labour force, other licences/authorisa- tions will be required for plant construction (such as those related to environment and safety).
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