To safeguard public health in the safe and proper use of all skin antiseptic products containing substances other than chlorhexidine, the Department of Health of Hong Kong decided that under the current regulatory control of pharmaceutical products with antiseptic ingredients, the sales control of skin antiseptic products containing benzalkonium salts, benzethonium salts, cetrimide, hydrogen peroxide and iodine/povidone iodine should be tightened after reviewing the existing definition of pharmaceutical products and taking reference of overseas regulatory practices for antiseptic products. In this connection, the “Guidance Notes on Classification of Products as Pharmaceutical Products” (the Guidance Notes) under the Pharmacy and Poisons Ordinance (Cap. 138) related to skin antiseptic products containing the aforementioned substances have been revised as follows:-
2) Unless otherwise stated, skin antiseptic products for human or animal use without any claims but containing well established active ingredients documented to be effective antiseptics, which include the following:
– Benzalkonium salts
– Benzethonium salts
– Hydrogen peroxide or
are classified as pharmaceutical products regardless of their concentration.
(b) General toiletry or cosmetic products containing antiseptic substances as preservatives, or intended for general cleansing or sanitary use, such as hand wash, body wash, cleanser and shampoo are generally not considered as pharmaceutical products.
To allow the traders to have sufficient time to adjust the marketing plan of their products, the Department of Health decided that the above revision will take effect 18 months from the date of issuance of this letter (the effective date would be 11 June 2022). When the new regulatory control takes effect, skin antiseptic products containing benzalkonium salts, benzethonium salts, cetrimide, hydrogen peroxide and iodine/povidone iodine that fulfil the definition of pharmaceutical product must be registered with the Department of Health before they can be legally sold in Hong Kong.
For more information, please refer to Drug Office website.