PHARMACEUTICAL PRODUCTS (HS 30)

1) Partial amendment to the Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, and 2) Partial amendment to the Public Notice on Designated Biological Products under Article 197, Paragraph 2 of the Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (1 page(s), in English)

The Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, and the Public Notice on Designated Biological Products under Article 197, Paragraph 2 of the Regulation for Enforcement will be partially amended to reflect the World Health Organization (WHO) standard on Summary Lot Protocol (SLP).