skip to main contents skip to main menu

Government Legislation

  • Announcement for the production, import, or supply of national essential pharmaceutical products
    • Competent Ministry : Ministry of Health and Welfare
    • Advance Publication of Legislation : 2022-02-25
    • Opinion Submission Deadline : 2022-03-21

1. Reason for amendment

  The aim is that, if the production, import, or supply of national essential pharmaceutical products designated under Article 2.19 of the Pharmaceutical Affairs Act and Article 34-8.1 of its Enforcement Decree are suspended, such fact shall be reported to the head of the Ministry of Food and Drug Safety in order to stabilize pharmaceutical product supply and take prior measures against possible threats to people’s health and safety caused by problems in essential pharmaceutical product supply.



2. Main contents

A. Not only the list of essential pharmaceutical products recommended by WHO but also the national essential pharmaceutical products designated under Article 2.19 of the Pharmaceutical Affairs Act and Article 34-8.1 of its Enforcement Decree are designated as the subject pharmaceutical products to be reported for stabilization of essential pharmaceutical product supply (Draft for Article 2.1.6)



Regulatory effect assessment
  • 생산·수입·공급 중단 보고대상 의약품 고시(규제영향분석서)_20220216.hwp [download]
Legislative proposal (draft)
  • 생산ㆍ수입ㆍ공급 중단 보고대상 의약품 고시 일부개정고시안.hwp [download]