Requirements for labelling and package insert of proprietary Chinese medicines to take effect from December 1
30 Nov 2011
Members of the public are reminded that provisions under the Chinese Medicine Ordinance (Cap 549, the Ordinance) concerning requirements for labelling and package insert of proprietary Chinese medicines (pCm) will come into force tomorrow (December 1) as an additional legal measure to protect public health in Hong Kong.
By then, all provisions under the Ordinance for regulation of Chinese medicines and Chinese medicine practitioners will have been put into effect.
A spokesman for the Department of Health (DH) said that it is stipulated in sections 143 and 144 of the Ordinance that no person shall sell or have in his possession for the purpose of selling, any pCm unless the package of the pCm is labelled in the prescribed manner, and with a package insert which complies with the prescribed requirements.
He explained that the detailed requirements are carried in sections 26 to 28 of the Chinese Medicines Regulation.
According to the Chinese Medicines Regulation, the container or package of a registered pCm must be properly labelled with the required terms (at least in Chinese) including name of medicine, name of main *(Note) active ingredients, country of origin, registration number, name of registration holder or product manufacturer, packing specification, dosage and method of usage, expiry date, and batch number.
Moreover, the package insert of a registered pCm must be supplied with the product, and contain the specified particulars (at least in Chinese) including name of medicine, name and quantity of main (Note) active ingredients, name of registration holder or product manufacturer, dosage and method of usage, functions/pharmacological action, indications (if any), contraindication (if any), side effects (if any), toxic effects (if any), precautions (if any), storage instructions, and packing specification.
The spokesman said that the maximum penalty for contravention of sections 143 and 144 is a fine of $100,000 and two years' imprisonment.
Exemptions provided under the Ordinance include pCm supplied or used for the purposes of import for re-export, scientific research, education, clinical trial and treating patients under direct care of Chinese medicine practitioners. Locally manufactured pCm for export only are not required to have package insert but still have to affix a label showing the name of the product, the name of the registration holder and the registration number.
The spokesman emphasised that the primary aim of the legislation is to facilitate the public to choose suitable pCm and use them safely and appropriately. Members of the public can call DH hotline 2319 5119 if in doubt, or visit the Chinese Medicine Council’s website at This link will open in a new windowwww.cmchk.org.hk for product details.
The Ordinance was enacted in July 1999 to provide a statutory framework for the regulation of both the practice and use of Chinese Medicine in Hong Kong.
"Chinese medicine practitioners, traders and other stakeholders have been kept informed and involved at different stages of development of the entire regulatory framework. The mandatory requirements for labelling and package insert of pCm is another important milestone," the spokesman said.
Other crucial regulatory measures already in place include the registration of Chinese medicine practitioners, the registration of pCm traders, registration of pCm, a control system for the import and export of pCm, market surveillance, an alert scheme and drug recall system.
*NOTE: If the medicine is composed of less than three kinds (i.e. one or two) of active ingredients, it should be each kind of active ingredient; or if composed of three or more kinds of active ingredients, it should be more than half of the total number of kinds of active ingredients.