04 Mar Guidance Notes on Classification of Products as “Pharmaceutical Products” under the Pharmacy and Poisons Ordinance (Cap. 138):
After two years of communication and discussion with the Pharmaceutical Services of Department of Health, the Product Classification Guidance Notes have been finalized and became effective July 2008. The Guidance Notes are particularly helpful in improving the knowledge of industry in product and provide exemption on certain ingredients from product registration, e.g. Biotin, amino acids, chondroitin, Coenzyme Q10, fish oil, lactobacillus, bioflavonoids, brewer’s yeast and more, provided the products containing these exempted ingredients do not make any medical claims. The Guidance Notes has provided some examples of medical claims for reference. For registration of health food as pharmaceutical product, clinical trials will not be required. Only relevant literature reference on efficacy for the usage claims of the composition of the product is required. Supporting data to prove safety and quality of the products are also required. If the authorities of the country of origin cannot certify the manufacturer to drug GMP, food GMP certification can be acceptable. Applicants can lodge registration applications while the stability studies are still on-going and the results of the completed studies have to be provided for evaluation prior to registration approval of the product concerned. This may help reducing the approval time.