Enhanced Control of Skin Antiseptics containing Chlorhexidine

  The decision made by the Pharmacy and Poisons Board of Hong Kong (the Board) on enhancing the control of skin antiseptic products containing chlorhexidine will come into effect on 8 July 2020.

   In response to the incidents of bacterial contamination of chlorhexidine containing skin antiseptics, the Board reviewed the current definition of pharmaceutical products, in making reference to the overseas regulatory practice of antiseptic products, and decided in Oct 2019 that the sales control of chlorhexidine containing skin antiseptics should be tightened. In this connection, the “Guidance Notes on Classification of Products as Pharmaceutical Product” (the Guidance Notes) related to chlorhexidine is revised as follows:-

“Skin antiseptic products containing chlorhexidine for human or animal use are classified as pharmaceutical products unless otherwise stated, or except:
(i) they are clearly labelled in English and Chinese for washing hands only (or equivalent); or
(ii) chlorhexidine is used as preservative or antimicrobials in cosmetic products.”

   From 8 July 2020 onwards, antiseptic products containing chlorhexidine which fulfill the definition of pharmaceutical product must be registered with the Board before they can be legally sold in Hong Kong.

Video on Wound Care by the Elderly Health Service of the Department of Health

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