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Government Legislation

  • Rules on the Manufacture and Sale Management of Biological Products, etc.
    • Competent Ministry : Ministry of Food and Drug Safety
    • Advance Publication of Legislation : 2020-12-22
    • Opinion Submission Deadline : 2021-02-01

A. Strengthen the storage and transport management of biological products, etc. (Articles 5 and 6)

- (Storage) Store biological products, etc., so they do not touch the ground, regularly test/calibrate automatic temperature loggers in refrigerators and freezers, and maintain such records. 

- (Transport) Prepare a device that can minimize physical impact during the transport of biological products, etc., and place automatic temperature loggers in transport facilities, while requiring the seller to sell with transport equipment in place.

B. Alleviate obligations to store a shipment certificate (Article 6 paragraph 1 subparagraph 6)

- Implement the following modifications: change from requiring the seller to have the recipient of biological products, etc., keep a shipment certificate to requiring the seller to store a shipment certificate, and alleviate the record-keeping burden for shipment certificates by allowing them to be stored as electronic documents.



Regulatory effect assessment
  • (규제영향분석서)_생물학적+제제+등의+제조·판매관리+규칙(수정).hwp [download]
Legislative proposal (draft)
  • 생물학적 제제 등의 제조ㆍ판매관리 규칙 일부개정안(결재본).hwp [download]