Health supplements are classified as prepackaged food, drug, or proprietary Chinese medicine. In considering the category of the product, the Department of Health takes into consideration the composition of the product, dosage form, and the nature of the claims made.
Products containing ingredients such as fish oil, CoQ10, grape seed extract etc may be categorized as food, but if the product carries medicinal claims it would be classified as a pharmaceutical product. Food products do not require registration, but are required to comply with Food and Drug (Composition and Labelling) Regulations. The responsibility of ensuring the safety and quality of the products rests with the importer/distributor.
Drugs are regulated by the Drug Office within the Department of Health, and registration is mandatory. Prior to 1st January 2016, products containing vitamins, fish liver oil, glucosamine were considered drug products in Hong Kong, but these are now permitted in the prepackaged food category, except certain vitamins with a daily dose exceeding published limits. Registration of drug products takes on average five months assuming the Drug Office is satisfied with all submitted dossiers. Registration costs HKD$2,470.
A Proprietary Chinese medicine is a product which only contains ingredients that are customarily used by the Chinese, or found in Chinese herbal publications. Such products are regulated under Chinese Medicine Ordinance and need pre-market approval.
Cosmetics in Hong Kong are governed by Chapter 456 Consumer Goods Safety Ordinance. Pre-marketing authorization is not required. No strict regulations are imposed on the import of cosmetics into Hong Kong. Manufacturers can use any ingredients except those prohibited or restricted by US FDA or EU Cosmetic Directive. The company or person responsible for marketing the products takes full responsibility of the product’s safety and quality. Many manufacturers adopt USA, EU and /or Japanese standards. Warnings or cautions on the label must be present in both English and Chinese.
NHP Consulting will provide all regulatory documentation and required Chinese translation to achieve market compliance for the Hong Kong marketplace, and our regulatory expertise is based in Hong Kong.