Government proposes to amend Chinese Medicine Ordinance
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"Despite the fact that relevant licensed traders of Chinese medicines have already been required by law to set up and maintain a system of recall for proprietary Chinese medicines (pCms), Chinese herbal medicines (Chms) and intermediate products generated in the course of manufacturing a pCm according to the Chinese Medicines Regulation (Cap. 549F) (CMR), the Court held in a judicial review case that the Director did not have the statutory power to order the recall of relevant products. Moreover, we have reviewed the CMO and found that there is currently no provision under the CMO or its subsidiary legislation providing that an unlicensed trader must, as directed by the Director, carry out recall actions regarding pCms or Chms which may pose threats to public health, such as Chms being distributed without licence as well as unregistered pCms being distributed, etc. We consider it necessary to amend the CMO and its subsidiary legislation to strengthen control," a spokesman for the Food and Health Bureau said today (May 31).
Apart from empowering the Director to make a Chinese medicine safety order, the Government also proposes to introduce an appeal mechanism to the CMO to allow a person bound by a Chinese medicine safety order to appeal against the decision of the Director.
Amendments to the CMR are also proposed by the Government to adjust the system of control required to be maintained by licensed Chinese medicines traders to enable rapid and, as far as practicable, complete recall of Chms, pCms and intermediate products.
On penalty, the Government proposes that a person bound by a Chinese medicine safety order who fails or refuses to comply with any requirements set out in the order commits an offence, and is liable to a fine at level six (i.e. $100,000) and imprisonment for two years. The proposed penalty is the same as the existing penalty for not complying with most other provisions under the CMO.
The Chinese Medicine (Amendment) Bill 2017 will be gazetted on June 2 and introduced into the Legislative Council on June 14.
Ends/Wednesday, May 31, 2017
Issued at HKT 16:15
Issued at HKT 16:15
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