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Press Release

Mandatory registration of proprietary Chinese medicines to take effect from December 3

2 Dec 2010

The public is reminded that the legislation under the Chinese Medicine Ordinance (Cap 549, the Ordinance) concerning the mandatory registration of proprietary Chinese medicines (pCm) will come into force tomorrow (December 3) as an additional legal measure to protect Hong Kong’s public health.

A spokesman for the Department of Health (DH) said that it is stipulated in section 119 of the Ordinance that all pCm must be registered by the Chinese Medicines Board (CMB) of the Hong Kong Chinese Medicine Council (CMC) before they can be sold, imported or in possession.

He explained that to be registered, any pCm must satisfy the CMB’s requirements in terms of its safety, quality and efficacy.

The spokesman said that upon the implementation of section 119, the sale, import or possession of unregistered pCm in Hong Kong will be an offence, liable on conviction to a maximum fine of $100,000 and two years' imprisonment.

He emphasised that the primary aim of the legislation is to protect the public against threats posed by unregistered pCm. Addressing concerns for special circumstances, the spokesman replied that there are provisions in the Ordinance for both defence and exemptions.

“In any proceedings for a contravention of section 119, it shall be a defence for a person charged to prove that he did not know, had no reason to suspect, and could not with reasonable diligence have discovered that the pCm was not registered.

“Moreover, the CMB may provide exemptions for pCm required for education or scientific research, including clinical trial; or imported for re-export; or prepared for or compounded by a registered or listed Chinese Medicine practitioner for supply or administer to a patient under his direct care,” he continued.

As regards concerns for information through labelling and package insert which will only become mandatory from December 1, 2011 onward, the spokesperson explained that such a date has been arrived at after balancing consumer’s right to know and operational feasibility. In fact, this interval approach is a widely adopted international practice.

In the interim, lists of pCm which met the requirements of the CMB have already been posted up on the CMB's website at . Members of the public can also call telephone 2319 5119 to enquire if in doubt.

The Ordinance was enacted in July 1999 to provide a statutory framework for the regulation of both the practice of Chinese Medicine as well as the use of Chinese drugs in Hong Kong.

“The Chinese medicine practitioners and traders and other stakeholders, have been kept informed and involved at different stages of development of the entire regulatory framework. The requirement for mandatory registration of pCm is but another important milestone,” the spokesman said.

Other crucial measures already in place include the registration of Chinese medicine practitioners, the registration of pCm traders, a control system for the import and export of pCm, market surveillance, alert scheme and drug recall system.

"We are encouraged that the implementation of the legislation has gained much acceptance from both user and providers. Indeed, both the Consumer Council and major pCm trade associations have indicated their support, not only by working closely with DH throughout the preparatory stage, but also through writing to the Legislative Council to register their commitment.

“After all, it will only be in Hong Kong’s interest to use pCm which are safe, of quality and efficacious," the spokesman concluded.

02 December 2010