(1) Reasons for Proposal
This Partial Amendment aims to additionally define the pharmaceutical wholesaler’s obligations and compliance to enhance quality control standards during drug distribution, clarify requirements for documentation so that drug substances registered with drug products can be reviewed together, prepare the basis to prepare a specific procedure to expeditiously introduce drugs, and improve and supplement some shortcomings observed in the operation of the current system.
(2) Major Provisions
A. Clarify requirements to submit documentation for drug substances registered in the marketing authorization of drug products (Article 4 paragraph 1 subparagraph 7)
Review drug products and drug substances used to manufacture the drugs for quality and clarify the scope of documentation to be submitted for registered drug substances among other documents required for submission in filing for the marketing authorization of drug products.
B. Prepare the basis to prepare a specific procedure to expeditiously introduce pharmaceuticals during import (Article 57 paragraph 3)
Prepare the basis to prepare a specific procedure to improve efficiency and transparency in the system while emergency introduction is currently used to supply pharmaceuticals (including alternative drugs) if they are not available in Korea.
C. Enhance the drug wholesaler’s obligations and compliance during drug distribution (attached Table 6)
Require the market authorization holder, the importer, and the pharmaceutical wholesaler to maintain a suitable temperature during pharmaceutical storage and transport and prevent the installation of temperature control devices on thermostats, add health functional food and cosmetics to the list of products that can be stored in storage facilities, specify the frequency of voluntary inspection, require all wholesalers except for qualified ones to complete training from the Korea Pharmaceutical Distribution Association, and require the outsourcing party to manage and supervise the outsourced party in an effort to enhance and update the drug wholesaler’s obligations and compliance during drug distribution and improve the quality of distributed drugs.
