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Republic of Korea - Proposed amendments to the "Regulation on Quasi-drug Approval, Notification and Review"

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Republic of Korea - Proposed amendments to the "Regulation on Quasi-drug Approval, Notification and Review"

Ministry of Food and Drug Safety has notified proposed amendments to the Regulation on Quasi-drug Approval, Notification and Review. The proposed amendments are as follows;

  • Adjusting range and type of paraoxybenzate (preserving agent) for quasi-drug such as toothpaste, mouth freshener and wet tissue for oral hygiene
  • Prohibiting the use of benzalkonium chloride as preserving agent for contact lens care item
  • Expanding designation of safety and efficacy issue products such as toothpaste, mouth freshener and wet tissue for oral hygiene using triclosan

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

Final date for comments: 60 days from notification

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures, so that these can be taken up suitably.






 


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