Press Release

Deregistration of oral pharmaceutical products containing ketoconazole to take effect from July 1, 2014

16 June 2014

The Department of Health (DH) today (June 16) reminded members of the public that oral pharmaceutical products containing ketoconazole would be deregistered and would not be available in the market with effect from July 1, 2014.

After taking into consideration that the incidence and seriousness of liver injury with oral ketoconazole were higher than with other anti-fungals, the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee (Registration Committee) of the Pharmacy and Poisons Board of Hong Kong decided at its meeting on February 26, 2014, to deregister oral pharmaceutical products containing ketoconazole. To allow sufficient time for doctors to review treatment plans and switch to suitable alternative treatments for their patients, the Registration Committee decided that the deregistration would not take effect until July 1, 2014. A This link will open in a new windowpress release on the Registration Committee's decision was issued on February 27, 2014, with a list of the 21 affected pharmaceutical products (see This link will open in a new windowattachment). The DH had also notified healthcare professionals of the Registration Committee's decision and related recommendations, and requested manufacturers and wholesalers concerned to recall the pharmaceutical products from the market.

"Patients who are still using the pharmaceutical products should contact their doctors immediately for switching to suitable alternative treatments. The DH has issued letters of reminder to healthcare professionals, manufacturers and wholesalers concerned on the commencement date of deregistration of the pharmaceutical products," a spokesman for the DH said.

"With effect from July 1, 2014, all drug manufacturers, wholesalers, retailers and healthcare professionals must stop selling or supplying oral pharmaceutical products containing ketoconazole. The manufacturers and wholesalers must also recall all affected pharmaceutical products from the market by June 30, 2014, after which the DH will take enforcement action against any illegal possession or sale of these unregistered pharmaceutical products," the spokesman said.

Under the Pharmacy and Poisons Ordinance (Cap 138), the sale and possession of unregistered pharmaceutical products are both criminal offences. The maximum penalty for each offence is a fine of $100,000 and two years' imprisonment.