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Swiss Chinese Law Association — Geneva

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Legal Observatory / Everyday Rights

Legal Update China Hong Kong SAR Rules in force

Hong Kong Department of Health Steps Up Enforcement Against Unregistered Injectables and Non-Exempted Human Tissue Products

The Hong Kong Department of Health raided four beauty premises and seized unregistered injectable pharmaceutical products and unapproved human tissue products, resulting in one arrest.

What Changed

  • Department of Health searched four beauty premises in Hong Kong SAR and seized over 100 vials of suspected Part 1 poisons and over 70 vials of unregistered pharmaceutical products.
  • A 38-year-old woman was arrested in Mong Kok on suspicion of unlawful possession of Part 1 poisons, unregistered pharmaceutical products, and illegal commercial dealing in human organs.
  • The DH confirmed that the seized product 'Elravie Re2O' has not been granted an exemption under the Human Organ Transplant Ordinance nor registered under the Pharmacy and Poisons Ordinance.

Beauty service providers, aesthetic health centres, pharmaceutical distributors, and healthcare practitioners operating in Hong Kong SAR face heightened scrutiny as the Department of Health (DH) intensifies enforcement against premises providing injection treatments using unregistered pharmaceutical products and non-exempted human tissue items. On October 16 and October 20, 2026, the DH executed raids across four beauty premises located in Tsim Sha Tsui, Mong Kok, Tsuen Wan, and Yuen Long.

During operations at the Tsim Sha Tsui and Mong Kok locations, enforcement officers seized over 100 vials/ampoules of suspected Part 1 poisons for injection and more than 70 vials/ampoules of suspected unregistered pharmaceutical injectables. The seized items included 20 vials of "Elravie Re2O", a Korean-packaged product claiming to contain human tissue. During a joint enforcement operation with the Hong Kong Police Force at the Mong Kok premises, a 38-year-old woman was arrested on suspicion of unlawful possession of Part 1 poisons and unregistered pharmaceutical products, as well as suspected unlawful commercial dealing in human organs.

Under the Human Organ Transplant Ordinance (Cap. 465), products manufactured from human tissue are classified as "regulated products" and require formal exemption approval from the Director of Health prior to sale in Hong Kong SAR. First convictions carry penalties up to a HK$50,000 fine and three months' imprisonment, increasing to a HK$100,000 fine and one year's imprisonment for subsequent offences. Additionally, under the Pharmacy and Poisons Ordinance (Cap. 138), all pharmaceutical products must satisfy statutory safety, efficacy, and quality standards and obtain registration with the Pharmacy and Poisons Board of Hong Kong before sale. Unlawful supply or possession carries a maximum fine of HK$100,000 and two years' imprisonment per offence.

The DH confirmed that while an exemption application for "Elravie Re2O" is currently being processed, no exemption has been granted to date, nor has any registration application as a pharmaceutical product been submitted. The DH reminded the public and trade operators that injection procedures constitute medical acts that must only be performed by registered medical practitioners or registered dentists.

Who May Be Affected

Beauty service providers, aesthetic clinics, medical practitioners, importers, and cosmetic product distributors operating in or exporting to Hong Kong SAR.

Cross-Border Context

Foreign cosmetics and pharmaceutical suppliers exporting injectables containing human tissue or specialized ingredients into Hong Kong SAR must comply strictly with domestic registration and exemption frameworks under Cap. 138 and Cap. 465.

What to check next

  • List of Registered Pharmaceutical Products maintained by the Pharmacy and Poisons Board of Hong Kong
  • List of Registered Medical Practitioners maintained by the Medical Council of Hong Kong
  • Exemption status of regulated human tissue products under the Human Organ Transplant Ordinance (Cap. 465)

This article provides general information and does not constitute legal advice. Consult the official text and obtain advice appropriate to your circumstances where needed.

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