In case an emergency situation posing risks to public health such as the occurrence of contagious diseases occurs, the smooth supply and use of quasi-drugs such as sanitary masks and hand sanitizers are necessary.

Unlike for drugs, however, the Pharmaceutical Affairs Act does not contain provisions regarding the obligation of quasi-drug manufacturers and sellers to maintain distribution order nor provisions regarding emergency manufacture and supply, etc. of quasi-drugs.

Therefore, to enable prompt response to public health emergencies, this proposal aims to have quasi-drug manufacturers and sellers, when supplying quasi-drugs necessary for the prevention or treatment, etc., of contagious diseases, to comply with matters prescribed by the Minister of Food and Drug Safety that are necessary for maintaining distribution order, while also providing the Minister of Food and Drug Safety with the ability to enable a manufacturer to manufacture or an importer to import quasi-drugs without approval or reports to appropriately handle national emergencies such as an epidemic (Articles 47 (1), 85-2).

Prescribe that to enable prompt response to public health emergencies, a manufacturer or seller of quasi-drugs, when supplying quasi-drugs necessary for the prevention or treatment, etc., of contagious diseases, shall comply with matters prescribed by the Minister of Food and Drug Safety that are necessary to maintain distribution order (Article 47 (1)).