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Government Legislation

  • Regulations on the storage and transportation of biological products, etc.
    • Competent Ministry : Ministry of Food and Drug Safety
    • Advance Publication of Legislation : 2022-02-25
    • Opinion Submission Deadline : 2022-03-17

1. Reason for establishment 

  With the revision of the Rules on the management of manufacture and sales of biological products, etc. (Prime Minister's Decree No. 1717, July 16, 2021), the aim is to decide the matters delegated by the Prime Minister's Decree on the procedures and methods, etc. needed for the storage and transportation of biological products, etc.



2. Main contents


A. Detailed matters needed for calibration such as establishment of calibration plans for the automatic temperature recorders installed in storage facilities and transportation equipment of biological products, etc. are prescribed (Draft for Article 2).


B. Conditions, etc. to minimize physical influences on the transportation equipment of biological products, etc. are prescribed (Draft for Article 3).


C. Detailed matters needed for verification such as establishment of verification plans for the transportation equipment of biological products, etc. are prescribed (Draft for Article 4).

Regulatory effect assessment
  • 생물학적 제제 등의 보관 및 수송 등에 관한 규정(규제영향분석서)_20220223.hwp [download]
Legislative proposal (draft)
  • 22-0222 생물학적 제제 등의 보관 및 수송에 관한 규정(행정예고안)(보고).hwp [download]