The Chinese Medicines Board has so far received about applications, of which also applied for transitional registration.

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1 Chinese Medicines Board to issue Notice of confirmation of transitional registration of proprietary Chinese medicine ********************************************************************* The Chinese Medicines Board of Chinese Medicine Council of Hong Kong today (March 31) starts to issue the Notice of confirmation of transitional registration of proprietary Chinese medicine to applicants of the products fulfilling the transitional registration requirements. The notice will also carry a transitional registration number for the respective product. Speaking at a press conference today, Member of the Chinese Medicine Board, Dr Gloria Tam, said: The registration system for proprietary Chinese medicines is an important milestone in the development of Chinese medicine. Through the registration system, the safety, quality and efficacy of proprietary Chinese medicines can be assured, and public health can be protected.." According to the Chinese Medicine Ordinance (Cap 549), all proprietary Chinese medicines manufactured or sold in Hong Kong must be registered. They must fulfill the registration requirements as prescribed by the Chinese Medicines Board in safety, quality and efficacy in order to get registration. The system of registration of proprietary Chinese medicines was implemented on December 19, A transitional registration arrangement is provided under the Ordinance. Where a proprietary Chinese medicine was, on 1 March 1999, manufactured or sold in Hong Kong, the relevant manufacturer, importer or local agent/representative of a manufacturer outside Hong Kong, may apply for transitional registration of the concerned product before June 30, The Chinese Medicines Board has so far received about applications, of which also applied for transitional registration. Dr Tam said: The Chinese Medicine Board and its Chinese Medicines Committee have processed all the applications. Today, we will provide an update on the progress made. About applications that fulfilled the transitional registration requirements will be issued the Notice of confirmation of transitional registration of proprietary Chinese medicine. For about applications for non-transitional registration

2 where the basic information for safeguarding public health has been provided, the respective applicant will receive a Notice of confirmation of (non-transitional) registration application of proprietary Chinese medicine. Moreover, there are 850 applications withdrawn by their respective applicants, and about applications which fail to provide the basic information for safeguarding public health will be rejected. Applicants of the remaining applications will be requested to provide the relevant information within a specified period for the Board s assessment. Also present in the press conference, the Chairman of The Chinese Medicines Committee, Mr Li Ying-sang, said the Notice of confirmation of transitional registration of proprietary Chinese medicine issued by the Board contained a transitional registration number with the format of HKP-XXXXX. Following the implementation of the relevant provisions of the Ordinance, the applicant should affix or print a label with the transitional registration number and other registered particulars on the external package of the respective proprietary Chinese medicine. Mr Li explained that the Chinese Medicines Committee had carried out an initial assessment on the applications for non-transitional registration. The Board will issue Notice of confirmation of (non-transitional) registration application of proprietary Chinese medicine to applications with the basic information for safeguarding public health provided. The confirmation notice contains a serial number with the format of HKNT-XXXXX. As this serial number is not a registration number, the applicant should not affix or print a label carrying the words proprietary Chinese medicine registration number or registration number on the external package of the respective proprietary Chinese medicine when using the number. The Chinese Medicines Board reminded members of the public to note the following when using Chinese proprietary medicines: 1. Proprietary Chinese medicine is a type of medicine and should be used with caution. 2. The use of any medicine (including proprietary Chinese medicine) may have side

3 effect. 3. Should get a clear idea of one s need before taking any medicine arbitrarily. 4. Natural product may not be safe. Members of the public should be careful about this point. 5. Even proprietary Chinese medicine will have interacting effects with other medicines. Patients should inform their healthcare providers about one s history of taking medicines. 6. Keep all medicines, including Chinese proprietary medicine, out of the reach of children. 7. Study carefully the label and instruction insert of the proprietary Chinese medicine. Don t buy medicines from dubious source; and 8. Seek medical advice promptly if adverse reaction arises or symptoms persist after the use of proprietary Chinese medicine. For enquires on the notices and registration numbers, Chinese medicines traders or members of the public may call the hotline set up by the DH on , or visit the website of the Chinese Medicine Council of Hong Kong ( End/Monday, March 31, 2008

4 Brief on Issue of Notice of Confirmation of Transitional Registration of Proprietary Chinese Medicine 1. The Chinese Medicines Board of Chinese Medicine Council of Hong Kong (the Chinese Medicines Board) starts to issue the Notice of confirmation of transitional registration of proprietary Chinese medicine today. 2. According to Chinese Medicine Ordinance, Cap. 549 of Laws of Hong Kong (the Ordinance), proprietary Chinese medicine refers to any proprietary product composed solely of any Chinese herb as the active ingredient, formulated in a finished dose form and known or claimed to be used for the diagnosis, treatment, prevention or alleviation of any disease, regulation of the functional states of the human body. 3. The Ordinance stipulates that all proprietary Chinese medicines manufactured or sold in Hong Kong must be registered, in order to protect public health. 4. According to the system of registration of proprietary Chinese medicine established under the Ordinance, any proprietary Chinese medicine must fulfill the registration requirements as prescribed by the Chinese Medicines Board in safety, quality and efficacy in order to get registration. 5. A transitional registration arrangement is provided under the Ordinance. Where a proprietary Chinese medicine was, on 1 March 1999, manufactured or sold in Hong Kong, the relevant manufacturer, importer or local agent/representative of a manufacturer outside Hong Kong, may apply for transitional registration of the proprietary Chinese medicine before 30 June The system of registration of proprietary Chinese medicine was implemented on 19 December, Up to the first quarter of 2008, the Chinese Medicines Board has received about 16,200 applications for registration of proprietary Chinese medicine, of which 14,000 applications have also applied for transitional registration. About 850 applications were withdrawn by the applicants subsequently. 7. Other than the applications withdrawn by their respective applicants, all of the applications for registration of proprietary Chinese medicines have been assessed. The Chinese Medicines Board has decided -

5 I. Transitional registration (1) to issue a Notice of confirmation of transitional registration of proprietary Chinese medicine to applicants of 5,700 proprietary Chinese medicines that fulfill the transitional registration requirements; (2) to issue a Notice of ineligible for transitional registration of proprietary Chinese medicine to applicants of 100 applications that do not fulfill the transitional registration requirements; (3) to refuse 3,000 applications where the applicants have not provided the basic information for safeguarding public health; and (4) to request applicants of 4,500 applications where the necessary business documents are not yet submitted, to provide the relevant information within a specified period. II. Non-transitional registration (1) to issue a Notice of confirmation of (non-transitional) registration application of proprietary Chinese medicine to applicants of 1,800 applications where the basic information for safeguarding public health has been provided; and (2) to request applicants of 250 applications where the basic information for safeguarding public health is not yet submitted, to provide the relevant information within a specified period. 8. The Notice of confirmation of transitional registration of proprietary Chinese medicine contains a transitional registration number with the format of HKP-XXXXX. The applicant should affix or print a label with the transitional registration number and other registered particulars on the external package of the respective proprietary Chinese medicine. 9. The Notice of confirmation of (non-transitional) registration application of proprietary Chinese medicine contains a serial number with the format of HKNT-XXXXX. As this serial number is not a registration number, the applicant should not affix or print a label carrying the words such as proprietary Chinese medicine registration number or registration number on the external package of the respective proprietary Chinese medicine when using the number.

Recall Guidelines. for Chinese Medicine Products

Recall Guidelines. for Chinese Medicine Products Recall Guidelines for Chinese Medicine Products April 2018 Recall Guidelines for Chinese Medicine Products Chinese Medicines Board Chinese Medicine Council of Hong Kong Compiled in September 2005 1 st