Enhanced Control of Skin Antiseptics containing Chlorhexidine

  The Pharmacy and Poisons Board of Hong Kong (the Board) has decided to enhance the control of skin antiseptic products containing chlorhexidine.

   In response to the recent incidents of bacterial contamination of chlorhexidine containing skin antiseptics, the Board has started to review the current definition of pharmaceutical products, in making reference to the overseas regulatory practice of antiseptic products, and decided 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.”

   In order to allow the traders to have sufficient time to adjust the marketing plan of their products, the Board decided that the above revision will take effect nine months from the date of issuance of this letter (the effective date would be 8th July 2020). Since then, 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.

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