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  • Partial Amendment to the Enforcement Rule of the Pharmaceutical Affairs Act
    • Competent Ministry : Ministry of Health and Welfare
    • Advance Publication of Legislation : 2024-02-19
    • Opinion Submission Deadline : 2024-04-01

1. Reasons for Amendment 

 This Amendment prescribes operating hours, designation and revocation standards and procedures, and other detailed operating standards for public late-night pharmacies newly inserted in the amended Pharmaceutical Affairs Act (Act No. 19359; promulgated on April 18, 2023). It deletes the “place of registration” item from the forms used for pharmacy establishment, status succession, and registration (change registration) of distributors of safe and readily available drugs, thereby aiming to protect personal information and simplify administrative procedures.  


2. Major Provisions

A. Prescribe operating hours, designation and revocation standards and procedures, and other detailed operating standards for public late-night pharmacies.

B. Delete the “place of registration” item from the forms for pharmacy establishment and registration, status succession, and registration (change registration) of distributors of safe and readily available drugs.

Regulatory effect assessment
  • 약사법 시행규칙(규제영향분석서)_20240222.hwp [download]
Legislative proposal (draft)
  • 약사법 시행규칙 일부개정령(안) 입법예고 공고안.hwpx [download]